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Latest FDA New Drug Application News

Verastem Oncology Announces the Initiation of a Rolling Submission of NDA to FDA Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

May 24
Last Trade: 4.12 -8.06 -66.17

Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of follow-up, in the second half of 2024 Plan to present the mature dataset from RAMP 201 at a medical conference in the second half of 2024 Avutometinib and defactinib combination have continued to show robust and durable response rates in ongoing RAMP 201 trial in patients with recurrent low-grade serous ovarian cancer Company to host...Read more


Amphastar Pharmaceuticals Receives FDA Approval for Albuterol Sulfate Inhalation Aerosol

May 22
Last Trade: 43.26 -0.09 -0.21

RANCHO CUCAMONGA, CA / ACCESSWIRE / May 22, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) today announced that the U.S. Food and Drug Administration ("FDA") has granted approval for the Company's Abbreviated New Drug Application ("ANDA") for Albuterol Sulfate Inhalation Aerosol, previously known as AMP-008. This product is for the treatment or prevention of bronchospasm in patients four years of age and older with reversible...Read more


Elite Pharmaceuticals Receives FDA Approval for Generic Methotrexate

May 20
Last Trade: 0.17 0.0015 0.89

NORTHVALE, NJ / ACCESSWIRE / May 20, 2024 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for generic Methotrexate Sodium 2.5 mg tablets. Methotrexate belongs to a class of drugs known as antimetabolites and will...Read more


CASI Pharmaceuticals Receives FDA Clearance On The Investigational New Drug (IND) Application For CID-103 In Immune Thrombocytopenia (ITP)

May 15
Last Trade: 3.55 0.31 9.44

BEIJING, May 15, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products announced today the following: On April 12, 2024 CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP). On May 13, 2024 CASI...Read more


Can-Fite BioPharma: FDA Grants IND Clearance for Namodenoson to Treat MASH Patients in a Phase IIb Study

RAMAT GAN, Israel / May 09, 2024 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson, for the treatment of patients with metabolic...Read more


BioAtla Announces FDA Clearance of Investigational New Drug Application for BA3361, a CAB-Nectin-4 Antibody Drug Conjugate for the Treatment of Multiple Tumors

May 6
Last Trade: 1.71 -0.39 -18.57

SAN DIEGO, May 06, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate BA3361 (CAB-Nectin-4) antibody drug conjugate (ADC) for the...Read more


VYNE Therapeutics Announces FDA Clearance of IND Application for VYN202, a Novel BD2-Selective BET Inhibitor

May 6
Last Trade: 2.58 -0.05 -1.90

In preclinical studies, VYN202 achieved consistent reductions in pro-inflammatory and disease-related biomarkers and improvements in disease severity across a variety of inflammatory and fibrotic models Phase 1a SAD/MAD trial expected to start this quarter BRIDGEWATER, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing...Read more


Context Therapeutics Announces FDA Clearance of IND Application for a Phase 1 Clinical Trial of CTIM-76

May 2
Last Trade: 2.00 0.05 2.56

CTIM-76 Phase 1 clinical trial to focus on CLDN6-positive gynecologic and testicular cancers Company expects to enroll first patient in mid-2024 PHILADELPHIA, May 02, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared its Investigational New Drug...Read more


Palatin Technologies Announces FDA Clearance of IND Application for the Co-Administration of Bremelanotide with Tirzepatide (GLP-1) for the Treatment of Obesity

May 2
Last Trade: 2.01 0.02 1.01

Phase 2 clinical study expected to begin in mid-calendar year 2024 Topline data expected by calendar year-end 2024 Hosting virtual KOL event "Beyond GLPs" on May 8, 2024 Focus will be on Company's metabolic program and the multiple roles for novel melanocortin receptor 4 agonists in treating obesity and weight loss maintenance CRANBURY, N.J., May 2, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE...Read more


Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)

April 30
Last Trade: 3.58 -0.02 -0.56

Company anticipates 10-month review for potential approval in Q1 2025 Eton expects ET-400 and Alkindi Sprinkle® to achieve potential combined peak sales of more than $50 million annually Product has patent protection through 2043  DEER PARK, Ill., April 30, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and...Read more


Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem

April 29
Last Trade: 1.35 -0.04 -2.88

First Oral Penem in the U.S. and Second New Oral Treatment for uUTIs in Over 25 Years, if approved Potential Approval Early Q4 2024 DUBLIN, Ireland and CHICAGO, April 29, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and...Read more


NKGen Biotech Announces FDA Clearance of Investigational New Drug (IND) Application for SNK01 NK Cell Therapy in Parkinson’s Disease

April 29
Last Trade: 1.42 -0.44 -23.66

NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson’s disease. The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024. SANTA ANA, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of...Read more


Prime Medicine Announces FDA Clearance of Investigational New Drug (IND) Application for PM359 for the Treatment of Chronic Granulomatous Disease (CGD)

April 29
Last Trade: 6.93 -0.02 -0.29

First-Ever Open IND for Prime Editing Technology PM359 is Prime Medicine’s Ex Vivo Product Candidate Designed to Correct a Prevalent Disease-Causing Mutation of CGD Initial Data Expected in 2025 CAMBRIDGE, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated, one-time curative genetic therapies, today announced that the U.S. Food...Read more


MannKind Announces IND Clearance From U.S. FDA to Start Phase 3 Study of Clofazimine Inhalation Suspension for Nontuberculous Mycobacterial (NTM) Lung Disease

April 29
Last Trade: 4.78 -0.04 -0.83

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for MNKD-101...Read more


XOMA Earns $9 Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)

April 25
Last Trade: 24.91 -0.17 -0.68

XOMA is entitled to a mid-single digit royalty on global OJEMDA™ sales First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and...Read more


HOOKIPA Pharma Announces FDA Clearance of its Investigational New Drug Application for HB-700 for the Treatment of KRAS-Mutated Cancers

April 24
Last Trade: 0.80 -0.24 -23.08

NEW YORK and VIENNA, Austria, April 24, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, today announced that the Company has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of...Read more


Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024

April 22
Last Trade: 8.27 -0.08 -0.96

BOSTON and LONDON, April 22, 2024 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy....Read more


PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine

April 18
Last Trade: 0.22 0.00 0.00

TORONTO, April 18, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced receipt of a Complete Response Letter (“CRL”) for its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022...Read more


IMUNON’s IND Application Cleared to Begin Human Testing of IMNN-101

April 18
Last Trade: 1.51 0.06 4.14

Company expects enrollment in Phase 1 proof-of-concept study of DNA-based vaccine technology to begin in the second quarter LAWRENCEVILLE, N.J., April 18, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces receipt of clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase...Read more


PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine

April 16
Last Trade: 0.22 0.00 0.00

TORONTO, April 16, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024. As announced...Read more


TransCode Therapeutics Announces FDA Clearance To Initiate Phase 1/2 Clinical Trial with TTX-MC138 in Patients with Advanced Solid Tumors

April 15
Last Trade: 1.79 0.40 28.78

BOSTON, April 15, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company’s Investigational New Drug (IND) application and concluded that the company may proceed with its Phase 1/2 multicenter, open-label, dose-escalation and...Read more


UroGen Pharma Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

April 15
Last Trade: 13.24 0.39 3.04

UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024 Anticipated advantages include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process, simplify the reconstitution procedure, and potentially extend intellectual property protection until as late as December 2041 PRINCETON, N.J. / Apr 15, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a...Read more


Ocugen Announces U.S. FDA Clearance of IND Amendment to Initiate OCU400 Phase 3 Clinical Trial — First Gene Therapy to Enter Phase 3 with a Broad Retinitis Pigmentosa Indication

April 8
Last Trade: 1.75 -0.03 -1.69

MALVERN, Pa., April 08, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) amendment to initiate a Phase 3 clinical trial of OCU400, a modifier gene therapy product...Read more


Caribou Biosciences Expands Clinical Development of CB-010 with FDA Clearance of IND in Lupus

April 4
Last Trade: 2.97 -0.04 -1.33

FDA has cleared Caribou’s IND application for CB-010 in lupus nephritis and extrarenal lupus; GALLOP Phase 1 clinical trial expected to initiate by YE 2024  Driven by encouraging initial safety and efficacy in the ongoing ANTLER trial for r/r B-NHL, CB-010 clinical development has expanded to include autoimmune diseases  Advancing ANTLER Phase 1 trial for 2L LBCL; initial dose expansion data to be shared at a medical...Read more


Context Therapeutics Submits IND Application to Evaluate CTIM-76 in Claudin 6-Positive Cancers

April 1
Last Trade: 2.00 0.05 2.56

PHILADELPHIA, April 01, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced that on March 28, 2024, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration to begin a first-in-human clinical study of CTIM-76. The IND supports the initiation of a Phase 1 dose...Read more


Sol-Gel’s Technologies Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream

April 1
Last Trade: 0.80 0.00 0.00

NESS ZIONA, Israel, April 01, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company pioneering treatments for patients with severe skin conditions, conducting a Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced that Padagis Israel Pharmaceuticals Ltd (“Padagis”), Sol-Gel’s...Read more


Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

March 28
Last Trade: 4.08 0.04 0.99

NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic...Read more


FDA Expands Indication for Gilead's Vemlidy (Tenofovir Alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six

March 28
Last Trade: 65.68 -0.49 -0.74

Efficacy and Safety Profile of Once-Daily Vemlidy Demonstrated in Children Six Years of Age (Weighing at Least 25kg) and Older  FOSTER CITY, Calif. / Mar 28, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic...Read more


Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia

March 28
Last Trade: 1.71 -0.04 -2.29

MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal...Read more


Syndax Pharmaceuticals Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia

March 26
Last Trade: 20.28 0.17 0.85

PDUFA action date set for September 26, 2024  NDA being reviewed under FDA's RTOR program  WALTHAM, Mass., March 26, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for revumenib, the...Read more


Amneal Pharmaceuticals Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

March 25
Last Trade: 6.45 0.01 0.16

Product references branded Ciprodex Represents another complex, high value new product BRIDGEWATER, N.J. / Mar 25, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This product is a combination of...Read more


Vertex Pharmaceuticals Announces FDA Clearance of Investigational New Drug Application for VX-407 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

March 21
Last Trade: 456.95 6.15 1.36

ADPKD is the most common inherited kidney disease, with no treatments currently available that address the underlying cause of disease Vertex to initiate a Phase 1 clinical trial in healthy volunteers this month ADPKD is Vertex’s 10th disease area in the clinic, further expanding the company’s pipeline of potentially transformative medicines for serious diseases BOSTON / Mar 21, 2024 / Business Wire / Vertex Pharmaceuticals...Read more


Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

March 19
Last Trade: 13.12 0.10 0.77

ICLUSIG Becomes the First and Only Targeted Treatment Approved in the U.S. for Frontline Ph+ Acute Lymphoblastic Leukemia (ALL) in Combination with Chemotherapy First FDA Approval in Ph+ ALL Based on Novel Primary Endpoint of Minimal Residual Disease (MRD)-negative Complete Remission (CR) Accelerated Approval Based on Data from the Phase 3 PhALLCON Trial, in which ICLUSIG Demonstrated Superiority in MRD-negative Complete Remission Rates...Read more


Journey Medical Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea

March 18
Last Trade: 3.60 0.00 0.00

SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, announced today that the FDA has accepted the Company’s New Drug...Read more


Imunon Files IND Application to Begin Human Testing of IMNN-101

March 13
Last Trade: 1.51 0.06 4.14

Company expects enrollment in Phase 1 proof-of-concept study of DNA-based vaccine technology to begin in Q2 The application follows guidance provided to IMUNON in Pre-IND meeting with the FDA  LAWRENCEVILLE, N.J., March 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces it has filed...Read more


Aprea Therapeutics Announces FDA Clearance of IND for APR-1051, its Next Generation WEE1 Kinase Inhibitor for Cyclin E Overexpressing Cancers

March 11
Last Trade: 5.30 0.28 5.58

Company plans to initiate Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) clinical trial evaluating, highly selective, oral WEE1 inhibitor, for monotherapy treatment of Cyclin E overexpressing cancers including breast and ovarian cancers Update from the ACESOT-1051 clinical trial expected in Q4 2024 DOYLESTOWN, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Aprea...Read more


Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

March 11
Last Trade: 6.16 -0.18 -2.84

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) to full approval. In February 2023, the FDA granted accelerated approval to FILSPARI as the first and only...Read more


Lexicon Pharmaceuticals Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA

March 11
Last Trade: 1.62 0.01 0.62

Preparations Underway for Resubmission of New Drug Application for Sotagliflozin as an Adjunct to Insulin Therapy for Glycemic Control in Patients with Type 1 Diabetes and Chronic Kidney Disease Resubmission is Anticipated Mid-2024 THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit...Read more


Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

March 6
Last Trade: 5.23 0.32 6.52

WASHINGTON, March 6, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation. In July 2023, the FDA had...Read more


Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

March 5
Last Trade: 0.65 -0.0053 -0.81

PITTSBURGH, March 05, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: “LIPO”) (“Lipella,” “our, “us” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for clinical testing of LP-410 in the treatment of oral Graft-Versus-Host Disease...Read more


Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients

March 4
Last Trade: 78.22 -0.78 -0.99

BEDFORD, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow® disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY® (Perflutren Lipid Microsphere) as an ultrasound...Read more


Zevra Therapeutics Provides FDA Update on the PDUFA Action Date for Arimoclomol as a Treatment for Niemann-Pick Disease Type C

March 4
Last Trade: 4.66 0.17 3.79

The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is September 21, 2024 CELEBRATION, Fla., March 04, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for arimoclomol, an investigational orally...Read more


SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

March 4
Last Trade: 42.38 -0.43 -1.00

STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with neurofibromatosis...Read more


Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma

March 1
Last Trade: 24.13 1.48 6.53

Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies Follows ongoing clinical study of CLN-619 alone and in combination with pembrolizumab in solid tumors, with anticipated updated clinical data in Q2 2024 CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company...Read more


Atara Biotherapeutics Receives FDA Clearance of IND Application in Lupus Nephritis for ATA3219, an Allogeneic CAR T Therapy

February 29
Last Trade: 0.62 -0.03 -4.00

Second IND Clearance for ATA3219 Following Non-Hodgkin’s Lymphoma (NHL) and First in an Autoimmune Disease Indication Initial Clinical Data in NHL Anticipated in H2 2024 and for Lupus Nephritis in H1 2025 THOUSAND OAKS, Calif. / Feb 29, 2024 / Business Wire / Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative...Read more


Spero Therapeutics Announces Clearance of IND for SPR206 to Treat MDR Gram-negative Bacterial Infections

February 28
Last Trade: 1.47 -0.01 -0.68

CAMBRIDGE, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it has received clearance by the U.S. Food and Drug Administration (FDA) for its investigational new drug...Read more


Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia

February 28
Last Trade: 4.08 0.04 0.99

PDUFA target action date of August 28, 2024 MAA validated and accepted for review by EMA in December 2023 NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has...Read more


Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

February 27
Last Trade: 2.44 -0.08 -3.12

BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in...Read more


Milestone Pharmaceuticals Announces Plan to Resubmit NDA for Etripamil for the Treatment of PSVT

February 26
Last Trade: 1.71 -0.04 -2.29

Resubmission of NDA expected 2Q2024 Operating Runway Extended Into Mid-2025 with Cash Conservation Measures MONTREAL and CHARLOTTE, N.C., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced plans to resubmit the New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT). Following the previously...Read more


U.S. Food And Drug Administration Grants Priority Review To Harmony Biosciences' Application For WAKIX® (pitolisant) In Pediatric Narcolepsy

February 21
Last Trade: 29.95 0.60 2.04

Prescription Drug User Fee Act date is June 21, 2024 PLYMOUTH MEETING, Pa., Feb. 21, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) granted priority review for its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients 6 years of age and older...Read more


Bristol-Myers Squibb: U.S. Food and Drug Administration (FDA) Accepts Supplemental New Drug Application for KRAZATI® (adagrasib) in Combination with Cetuximab as Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated...

February 20
Last Trade: 41.24 -0.30 -0.72

U.S. FDA has assigned a target action date of June 21, 2024 Application based on results from the Phase 1/2 KRYSTAL-1 study PRINCETON, N.J. / Feb 20, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients...Read more


Atara Biotherapeutics Announces Submission of Investigational New Drug Application for ATA3219 for Treatment of Lupus Nephritis

February 14
Last Trade: 0.62 -0.03 -4.00

ATA3219 is an Allogeneic CAR T-Cell Therapy Targeting CD19+ B Cells to Potentially Address the Root Cause of Lupus Nephritis (LN) ATA3219 Is Designed to Combine the Natural Biology of Unedited T Cells and the Benefits of an Allogeneic CAR T Approach With Preclinical Data Demonstrating Potential Efficacy in LN Second IND Submission for ATA3219, Following Non-Hodgkin’s Lymphoma (NHL) IND Clearance Received in Q3 2023 THOUSAND OAKS,...Read more


U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Augtyro™ (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors

February 14
Last Trade: 41.24 -0.30 -0.72

Application based on results from the TRIDENT-1 and CARE trials, in which Augtyro demonstrated clinically meaningful response rates If approved, Augtyro will provide a new, next-generation option for patients with NTRK-positive locally advanced or metastatic solid tumors who have high unmet medical needs The U.S. Food and Drug Administration assigned a target action date of June 15, 2024 PRINCETON, N.J. / Feb 14, 2024 / Business Wire...Read more


Merrimack Pharmaceuticals Reports Ipsen Announcement of Approval By The US FDA of Onivyde® (Irinotecan Liposome Injection) Plus 5 Fluorouracil/Leucovorin and Oxaliplatin (NALIRIFOX) as a First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma...

February 13
Last Trade: 15.13 0.00 0.00

FDA Approval Triggers $225 Million Milestone Payment from Ipsen to Merrimack Merrimack Expects to Hold Special Meeting of Stockholders to Approve Plan of Dissolution in May 2024 Following Approval of Plan of Dissolution, Merrimack Expects to Issue a Liquidating Dividend Currently Estimated to be Between $14.65 and $15.35 per Share in the Late Spring or Early Summer CAMBRIDGE, Mass. / Feb 13, 2024 / Business Wire / Merrimack...Read more


Lineage Cell Therapeutics Announces FDA Clearance of IND Amendment for OPC1 Cell Transplant for the Treatment of Spinal Cord Injury

February 13
Last Trade: 1.04 0.01 0.97

The DOSED Clinical Study Will Evaluate a Novel Delivery Device in Subacute and Chronic Spinal Cord Injury Patients CARLSBAD, Calif. / Feb 13, 2024 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New...Read more


CymaBay Therapeutics Announces FDA Acceptance of NDA and Priority Review for Seladelpar for the Treatment of Primary Biliary Cholangitis

February 12
Last Trade: 32.48 0.00 0.00

FDA has granted Priority Review with a target PDUFA date of August 14  NEWARK, Calif., Feb. 12, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for...Read more


PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine

February 12
Last Trade: 0.22 0.00 0.00

TORONTO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, provides an update of its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine that was accepted by the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of April 29, 2024. The ANDA...Read more


OKYO Pharma Receives FDA Approval of IND for OK-101 in Neuropathic Corneal Pain

February 9
Last Trade: 1.32 -0.16 -11.06

OK-101 is the first IND clearance granted by FDA for a drug to begin clinical studies specifically to treat patients suffering with neuropathic corneal pain (NCP), a major unmet medical need The initial trial of OK-101 to treat NCP is designed as a randomized, placebo-controlled, double-masked Phase 2 clinical trial and is planned to begin in 2Q 2024 NCP is an Orphan disease as listed in the National Organization for Rare Disorders...Read more


Aprea Therapeutics Announces Submission of IND Application for APR-1051, a Next Generation WEE1 Kinase Inhibitor

February 6
Last Trade: 5.30 0.28 5.58

DOYLESTOWN, Pa., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) to initiate clinical trials of APR-1051. APR-1051 is an oral inhibitor of WEE1 kinase,...Read more


Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia

February 5
Last Trade: 5.23 0.32 6.52

WASHINGTON, Feb. 5, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on February 4, 2024, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation, the FDA has identified...Read more


BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

February 5
Last Trade: 27.94 0.18 0.65

Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application Marketing Authorization Application accepted by the European Medicines Agency (EMA) with additional global regulatory submissions planned In ATTRibute-CM, acoramidis treatment demonstrated an 81% absolute survival rate and a 0.29 observed mean annual...Read more


Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VTR-297 a Topical Antifungal Candidate for the Treatment of Onychomycosis

January 31
Last Trade: 5.23 0.32 6.52

WASHINGTON, Jan. 31, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VTR-297 for the treatment of onychomycosis. Onychomycosis, or tinea unguium, is a fungal infection of the nail. Onychomycosis can result in discoloration of the nail, onycholysis (nail separation from the...Read more


Filament Health Announces FDA Opening Of Investigational New Drug Application For Substance Use Disorders

January 31
Last Trade: 0.05 0.00 0.00

The active IND allows initiation of US research with Filament's botanical psilocybin drug candidate for the potential treatment of substance use disorders including OUD VANCOUVER, BC, Jan. 31, 2024 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical‐stage natural psychedelic drug development company, today announced that the U.S. Food and Drug Administration (FDA) has...Read more


23andMe Announces FDA Clearance of IND Application for its Dual Mechanism Antibody, 23ME-01473, Targeting ULBP6

January 31
Last Trade: 0.51 0.0036 0.71

23ME-01473 (‘1473) seeks to treat cancer by restoring anti-tumor immunity through NK and T cells ‘1473 has dual mechanisms of blocking the immunosuppressive effects of soluble ULBP6, and inducing Fc receptor-mediated killing of ULBP6-expressing cancer cells through enhanced effector function Phase 1 clinical study in patients with solid tumors to commence in H1 2024 The target for ‘1473 was discovered through 23andMe’s proprietary...Read more


Lexaria Bioscience Submits Investigational New Drug Application

January 30
Last Trade: 3.12 0.24 8.33

KELOWNA, BC / ACCESSWIRE / January 30, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX; LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces that, on January 29, it submitted its much-anticipated Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its planned U.S. phase 1b hypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD. This IND submission...Read more


Liquidia Provides Update on New Drug Application for YUTREPIA™ (treprostinil) inhalation powder

January 25
Last Trade: 12.42 -0.42 -3.27

MORRISVILLE, N.C., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) provided an update on its review of the New Drug Application (NDA) for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA informed the Company that...Read more


UroGen Pharma Initiates Submission of a Rolling NDA to the FDA for UGN-102

January 24
Last Trade: 13.24 0.39 3.04

PRINCETON, N.J. / Jan 24, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the submission of the Chemistry, Manufacturing, and Controls (CMC) section of the New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution to the U.S. Food and Drug Administration (FDA). "The...Read more


CytomX Therapeutics Announces FDA Clearance of IND Applications for CX-2051, a Probody® Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a Conditionally Activated Interferon Alpha-2b

January 24
Last Trade: 1.75 -0.08 -4.37

Initiation of CX-2051 Phase 1 clinical study in EpCAM positive tumors including colorectal cancer anticipated in 1H 2024  Initiation of CX-801 Phase 1 clinical study in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma also anticipated in 1H 2024  SOUTH SAN FRANCISCO, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally...Read more


Vanda Pharmaceuticals Receives FDA Approval to Proceed with Investigational New Drug VCA-894A, a Novel Antisense Oligonucleotide Candidate for the Treatment of Charcot-Marie-Tooth Disease, Type 2S

January 23
Last Trade: 5.23 0.32 6.52

WASHINGTON, Jan. 23, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate VCA-894A for the treatment of a patient with Charcot-Marie-Tooth disease, axonal, type 2S (CMT2S), caused by cryptic splice site variants within the IGHMBP2 gene. CMT2S is a rare subtype of...Read more


ANI Pharmaceuticals Announces the FDA Approval and Launch of Indomethacin Oral Suspension, USP

January 16
Last Trade: 61.32 0.96 1.59

BAUDETTE, Minn., Jan. 16, 2024 (GLOBE NEWSWIRE) --  ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP. ANI’s Indomethacin OS is the generic version of the Reference Listed Drug (RLD) Indocin® Oral Suspension. The current annual U.S. market for...Read more


Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)

January 11
Last Trade: 78.22 -0.78 -0.99

BEDFORD, Mass., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that its Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (177Lu-PNT2003), a generic version of LUTATHERA® (lutetium Lu 177 dotatate),...Read more


Corbus Pharmaceuticals Announces FDA Clearance of IND Application for its anti-αvβ8 monoclonal antibody (CRB-601)

January 9
Last Trade: 45.02 3.64 8.80

CRB-601 is designed to block the activation of latent TGFβ in the tumor microenvironment Phase 1 clinical study set to commence H1 2024 Pre-clinical data presented demonstrates robust anti-tumor activity in solid tumor models NORWOOD, Mass., Jan. 09, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today announced...Read more


Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors

January 8
Last Trade: 3.08 0.00 0.00

NUV-1511 is the first clinical candidate from the company’s novel drug-drug conjugate platform Company anticipates initiating a Phase 1/2 clinical study of NUV-1511 in 1H 2024 NEW YORK / Jan 08, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, announced today that the U.S. Food and Drug...Read more


Veru Submits IND Application to FDA for the Development of Enobosarm to Prevent Muscle Loss While Augmenting Fat Loss in Combination with GLP-1 Drugs for Weight Loss

January 8
Last Trade: 1.23 -0.04 -3.15

MIAMI, FL, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, oncology, and viral induced acute respiratory distress syndrome, today announced submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for the development of enobosarm for obesity. Glucagon-like peptide-1...Read more


Zevra Therapeutics Receives FDA Acceptance of Resubmission of NDA for Arimoclomol as a Treatment for Niemann-Pick Disease Type C

January 8
Last Trade: 4.66 0.17 3.79

Arimoclomol NDA has been assigned a PDUFA action date of June 21, 2024 CELEBRATION, Fla., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra or the Company), a rare disease therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for arimoclomol as an orally-delivered, first-in-class...Read more


Sana Biotechnology Announces FDA Clearance of Investigational New Drug Application for SC262, a Hypoimmune-modified, CD22-directed Allogeneic CAR T Therapy, for Patients with Relapsed or Refractory B-cell Malignancies

January 5
Last Trade: 8.02 0.04 0.50

SEATTLE, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate a study of SC262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior...Read more


Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea

January 5
Last Trade: 3.60 0.00 0.00

If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea NDA submission supported by positive Phase 3 clinical data SCOTTSDALE, Ariz., Jan. 05, 2024 (GLOBE NEWSWIRE) --  Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling...Read more


Coya Therapeutics Announces Successful Pre-IND and Type C Meetings with the FDA to Advance the Development of COYA 302 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

January 5
Last Trade: 7.91 -0.24 -2.94

Coya has a clear path towards submission of the IND application to the FDA in the second quarter of 2024, with a planned initiation of a well-controlled, double-blind clinical trial of COYA 302 in patients with ALS upon acceptance of the IND HOUSTON / Jan 05, 2024 / Business Wire / Coya Therapeutics, Inc. (“Coya”), a clinical-stage biotechnology company today announced successful meetings with the U.S. Food and Drug Administration...Read more


BridgeBio Pharma announces FDA clearance of IND application for BBO-8520, a first-in-class direct inhibitor of KRASG12C (ON)

January 3
Last Trade: 27.94 0.18 0.65

The United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for BBO-8520, a first-in-class orally bioavailable and potentially highly potent small molecule direct inhibitor of KRASG12C that binds to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRASG12C BBO-8520 is expected to significantly improve outcomes for patients with KRASG12C driven...Read more


Applied Therapeutics Announces MAA Validation and NDA Submission of Govorestat (AT-007) for Treatment of Classic Galactosemia

January 3
Last Trade: 4.08 0.04 0.99

NDA submitted to FDA and MAA validated by EMA in December 2023 Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term clinical outcomes benefit across a range of functional measures and favorable safety profile NEW YORK, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a...Read more


Pasithea Therapeutics Announces FDA Acceptance of IND Application to Evaluate PAS-004 in Advanced Cancer Patients

January 2
Last Trade: 6.40 -0.15 -2.29

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials  Phase 1 dose escalation study in patients with MAPK pathway driven advanced solid tumors to begin in Q1 2024 Initial readout expected as early as Q3 2024  SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) --  Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the...Read more


NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

December 28
Last Trade: 4.13 0.16 3.90

CAMBRIDGE, Mass., Dec. 28, 2023 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The IND application supports a Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that...Read more


Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration

December 27
Last Trade: 4.66 0.17 3.79

CELEBRATION, Fla., Dec. 27, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (NDA) for arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (NPC) to the U.S. Food and Drug Administration (FDA) on December 22, 2023. Based on standard NDA resubmission review timelines, an...Read more


Amgen Provides Regulatory Update On Status Of Lumakras® (Sotorasib)

December 26
Last Trade: 305.84 -0.66 -0.22

FDA Has Issued New Postmarketing Requirement LUMAKRAS Dosing Confirmed at 960 mg Once-Daily for Patients With KRAS G12C-Mutated NSCLC Under Accelerated Approval THOUSAND OAKS, Calif., Dec. 26, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib). This review,...Read more


Elite Pharmaceuticals Files ANDA with US FDA to Market Central Nervous System Stimulant

December 26
Last Trade: 0.17 0.0015 0.89

NORTHVALE, NJ / ACCESSWIRE / December 26, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today announced the US Food and Drug Administration's (FDA) acceptance for review of an Abbreviated New Drug Application (ANDA) on December 21, 2023, for an undisclosed generic drug product in a class of...Read more


Milestone Pharmaceuticals Receives Refusal to File Letter from U.S. FDA for New Drug Application for Etripamil in the Treatment of PSVT

December 26
Last Trade: 1.71 -0.04 -2.29

MONTREAL and CHARLOTTE, N.C., Dec. 26, 2023 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) announced today that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for self-administered etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Upon preliminary review, the FDA determined that the...Read more


Senti Biosciences Announces FDA Clearance of IND Application for SENTI-202 for the Treatment of Relapsed or Refractory Hematologic Malignancies Including Acute Myeloid Leukemia

December 22
Last Trade: 0.34 -0.01 -3.11

First patient in Phase 1 clinical trial expected to be treated in Q2 2024  Initial clinical efficacy data expected by year-end 2024 and durability data expected in 2025  SENTI-202 is a potential first-in-class off-the-shelf CAR-NK cell therapy using Logic Gated Gene Circuits to selectively target cancer cells while sparing healthy bone marrow cells  SOUTH SAN FRANCISCO, Calif., Dec. 22, 2023 (GLOBE NEWSWIRE) -- Senti...Read more


Merck Provides U.S. Regulatory Update on Gefapixant

December 20
Last Trade: 129.49 -1.60 -1.22

RAHWAY, N.J. / Dec 20, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or...Read more


Aurinia Pharmaceuticals Submits IND Application to US Food & Drug Administration for AUR 200

December 20
Last Trade: 5.21 -0.03 -0.57

AUR200, a potent recombinant fusion protein, has a clinically validated MOA with a high affinity for targeting both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand) Upon FDA clearance of the IND, AUR 200 will be studied in a Phase 1 first-in-human trial in healthy volunteers, marking a significant advancement for Aurinia’s emerging autoimmune pipeline ROCKVILLE, Md. & EDMONTON, Alberta / Dec 20, 2023 /...Read more


Panbela Therapeutics Announces US WorldMeds NDA Approval for Eflornithine (DFMO) in Pediatric Neuroblastoma

December 18
Last Trade: 0.36 -0.75 -67.57

MINNEAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that US WorldMeds®1 (USWM), a Kentucky-based specialty pharmaceutical company to whom it divested certain assets in its eflornithine pediatric neuroblastoma program, received FDA approval of its New Drug...Read more


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