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Latest Biotech and Pharma FDA News

FILTER BY TOPIC:     FDA Approvals   FDA 510(k) Clearance   New Drug Application   Fast Track Designation   Orphan Drug Designation   Biologics License Application   Breakthrough Therapy Designation   Emergency Use Authorization   Advanced Therapy Designation  

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


Guardant Health: FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option

May 23
Last Trade: 25.52 3.01 13.37

The advisory committee offers valuable non-binding recommendations for the FDA Blood test offers a convenient non-invasive screening option that overcomes barriers associated with current non-invasive screening tests Shield remains on track to become the first FDA-approved blood test that meets performance requirements for Medicare coverage1 PALO ALTO, Calif. / May 23, 2024 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a...Read more


Theriva™ Biologics Announces Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer

May 23
Last Trade: 0.30 -0.03 -10.06

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve...Read more


Cartesian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Descartes-08 for the Treatment of Myasthenia Gravis

May 22
Last Trade: 24.57 -0.89 -3.50

GAITHERSBURG, Md., May 22, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for Descartes-08 for the treatment of myasthenia gravis (“MG”). Descartes-08, the Company’s lead...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


DURECT Receives FDA Breakthrough Therapy Designation for Larsucosterol in Alcohol-Associated Hepatitis

May 21
Last Trade: 1.30 0.04 3.17

DURECT plans to confirm the efficacy and safety of larsucosterol in a registrational Phase 3 clinical trial  CUPERTINO, Calif., May 21, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury and cancer, today announced that the U.S. Food and...Read more


Bristol Myers Squibb Announces Updated Action Date by the U.S. Food and Drug Administration for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

May 21
Last Trade: 41.24 -0.30 -0.72

Updated Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024 PRINCETON, N.J. / May 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with...Read more


Roche: FDA Grants Breakthrough Therapy Designation to Genentech’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting  Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment  This is the 29th Breakthrough Therapy Designation for Genentech’s...Read more


Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA

May 20
Last Trade: 0.62 -0.03 -4.00

First Allogeneic T-Cell Therapy BLA Submission to U.S. Food and Drug Administration If Approved, Tab-cel Would be First Approved Therapy in U.S. for EBV+ PTLD Acceptance of BLA Will Trigger $20 Million Milestone Payment from Pierre Fabre Laboratories, with Potential for Additional $60 Million Milestone Upon FDA Approval THOUSAND OAKS, Calif. / May 20, 2024 / Business Wire / Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in...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


Amgen: FDA Approves Imdelltra™ (Tarlatamab-dlle), The First And Only T-cell Engager Therapy For The Treatment of Extensive-stage Small Cell Lung Cancer

May 16
Last Trade: 305.84 -0.66 -0.22

Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study Amgen to Host Webcast Investor Call on May 20, 2024 at 1:00 p.m. PT THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug...Read more


Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-655

May 16
Last Trade: 67.95 1.27 1.90

CAMBRIDGE, Mass., May 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell...Read more


Axogen Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®

ALACHUA, Fla. and TAMPA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, is pleased to announce that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for licensure of Avance Nerve Graft® on May 15, 2024. “Today’s milestone...Read more


Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma

May 15
Last Trade: 41.24 -0.30 -0.72

95.7% of patients responded to Breyanzi in the TRANSCEND FL trial Breyanzi provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months Breyanzi is a personalized therapy with a differentiated profile, offering durable responses and a consistent safety profile across trials PRINCETON, N.J. / May 15, 2024 / Business Wire / Bristol Myers Squibb...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


Roche announces FDA approval of one of the first HPV self-collection solutions in the U.S., expanding access and screening options to help eliminate cervical cancer

May 15
Last Trade: 31.60 -0.19 -0.60

More than half of all U.S. cervical cancer patients are underscreened1, which makes reducing barriers to sample collection and increasing access to screenings crucial to ultimately helping eliminate this deadly disease. Each year in the U.S., more than 13,000 patients are diagnosed with cervical cancer and approximately 4,000 die from this preventable disease, caused by HPV infection.1 Roche’s human papillomavirus (HPV) self-collection...Read more


Biogen and Eisai Initiate Rolling Biologics License Application to US FDA for LEQEMBI® (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status

May 14
Last Trade: 217.81 -0.25 -0.11

TOKYO and CAMBRIDGE, Mass., May 14, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand...Read more


Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism

May 14
Last Trade: 130.41 0.97 0.75

Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to August 14, 2024 COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH...Read more


Dynavax Technologies Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S.

May 14
Last Trade: 11.39 -0.46 -3.88

EMERYVILLE, Calif., May 14, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) today provided a regulatory update for the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response...Read more


Profound Medical Receives U.S. FDA 510(k) Clearance for ‘Contouring Assistant’ AI Module that Enables Creation of an Automated TULSA Treatment Plan

May 14
Last Trade: 7.35 -0.07 -0.94

Prostate segmentation using a deep learning convolutional neural network  Model uses 24,611,072 parameters extracted from 7,466 training images  Validated in standalone and multi-reader, multi-case clinical studies conducted by world-renowned experts  Urologists testing this TULSA-AI module improved their segmentation accuracy and were 32% faster in their contours  TORONTO, May 14, 2024 (GLOBE NEWSWIRE) --...Read more


PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™

May 14
Last Trade: 37.20 0.07 0.19

PDUFA target action date of November 13, 2024  WARREN, N.J., May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency. The application has been granted Priority Review with a target regulatory action date of November 13, 2024. "We are...Read more


Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication

May 13
Last Trade: 33.90 -0.10 -0.29

Clinolipid provides calories and essential fatty acids for parenteral nutrition Expanded indication demonstrates Baxter’s continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates to adults DEERFIELD, Ill. / May 13, 2024 / Business Wire / Baxter International Inc. (NYSE:BAX), a global leader in nutrition therapy, today announced U.S. FDA approval of an expanded indication for Clinolipid (Lipid...Read more


Merus: Petosemtamab granted Breakthrough Therapy Designation by the U.S. FDA

May 13
Last Trade: 59.99 15.92 36.12

Petosemtamab granted BTD for the treatment of previously treated HNSCC UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for...Read more


Tiziana Life Sciences Files for Orphan Drug Designation for Intranasal Foralumab

May 13
Last Trade: 0.81 0.07 9.34

NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). This request would make...Read more


QIAGEN receives FDA clearance for QIAstat-Dx respiratory syndromic testing panel for fast and accurate results

May 13
Last Trade: 43.73 0.56 1.30

Germantown, Maryland, and Venlo, the Netherlands, May 13, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use. The QIAstat-Dx Respiratory Panel Plus is designed to support clinical decision-making in diagnosing upper respiratory infections and covers 21 viral and...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)

If approved, Dupixent would be the first treatment in the U.S. indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell Current treatment options for adolescents with CRSwNP leave many patients with uncontrolled disease and often result in the recurrence of nasal...Read more


PharmaTher Announces Assigned FDA Approval Goal Date of its Priority Original Abbreviated New Drug Application for Ketamine

May 10
Last Trade: 0.22 0.00 0.00

TORONTO, May 10, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced receipt of an Amendment Acknowledgment Letter (“AAL”) for its Priority Original Abbreviated New Drug Application (“ANDA”) for Ketamine from the U.S. Food and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal...Read more


Moderna Announces Update on Investigational RSV Vaccine

May 10
Last Trade: 166.61 2.60 1.59

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024 Agency has indicated it expects to complete the review by end of May CAMBRIDGE, MA / ACCESSWIRE / May 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that due to administrative constraints, the agency...Read more


Orthofix Medical Announces FDA 510(k) Clearance for the Rodeo Telescopic Nail

May 9
Last Trade: 14.89 0.02 0.13

LEWISVILLE, Texas / May 09, 2024 / Business Wire / Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative device indicated to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta (OI). The nail...Read more


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

May 9
Last Trade: 2.46 0.02 0.82

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


Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Etedesiran (AOC 1001) for Treatment of Myotonic Dystrophy Type 1

May 8
Last Trade: 27.45 -0.02 -0.07

Avidity initiating global Phase 3 HARBOR™ study for delpacibart etedesiran this quarter Delpacibart etedesiran data from MARINA-OLE™ showed reversal of disease progression in multiple functional measures in DM1 compared to END-DM1 natural history data SAN DIEGO, May 8, 2024 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA...Read more


Precision BioSciences Announces Receipt of FDA Fast Track Designation for ECUR-506, iECURE’s Program for the Treatment of Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

May 7
Last Trade: 12.74 -0.26 -2.00

DURHAM, N.C. / May 07, 2024 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, elimination, and excision, today announced that its partner iECURE has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ECUR-506. ECUR-506...Read more


Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC

May 6
Last Trade: 59.99 15.92 36.12

UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab...Read more


Crofelemer, Jaguar Health’s Prescription Drug Conditionally Approved by the FDA for Chemotherapy-Induced Diarrhea in Dogs, is the Subject of the Company’s Investigational New Animal Drug Application for the Indication of General Diarrhea in Dogs

May 6
Last Trade: 4.63 -0.50 -9.75

Diarrhea is one of the most common reasons for veterinary visits for dogs and the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat canine diarrhea SAN FRANCISCO, CA / ACCESSWIRE / May 6, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it has established a new Investigational New Animal Drug (INAD) file with the Center...Read more


Masimo Receives FDA Clearance for Stork™ Over-the-Counter (OTC) Baby Monitoring System

May 6
Last Trade: 127.00 2.25 1.80

With This Clearance, Stork Provides Continuous Monitoring of Oxygen Saturation, Pulse Rate, and Skin Temperature, with Alarms, for Babies up to 18 Months, at Home, Without a Prescription IRVINE, Calif. / May 06, 2024 / Business Wire / Masimo (NASDAQ: MASI), a global leader in innovative monitoring technologies currently celebrating its 35th anniversary, announced FDA clearance of Stork™, a baby monitoring system that provides alarms to...Read more


Outset Medical's TabloCart with Prefiltration Receives FDA 510(k) Clearance

May 6
Last Trade: 3.87 -0.12 -3.01

SAN JOSE, Calif. / May 06, 2024 / Business Wire / Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of TabloCartTM with prefiltration, an innovative optional accessory for the Tablo® Hemodialysis System. Outset has resumed distribution...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


U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

May 6
Last Trade: 41.24 -0.30 -0.72

Application based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor The FDA assigned a target action date of February 28, 2025 PRINCETON, N.J. / May 06, 2024 /...Read more


MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease

May 6
Last Trade: 4.78 -0.04 -0.83

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 06, 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 granted Fast Track designation of Clofazimine Inhalation Suspension (MNKD-101) for the...Read more


OrthoPediatrics Receives “Breakthrough Device” Designation from FDA for eLLi™ Growing Rod System for Pediatric Patients with Scoliosis

WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received the “Breakthrough Device” Designation from the Food and Drug Administration (“FDA”) for its new eLLi surgical device, an implant designed to address severe pathology associated with Early Onset Scoliosis (EOS), which can be...Read more


Taysha Gene Therapies Announces Regenerative Medicine Advanced Therapy (RMAT) Designation Granted by U.S. FDA for TSHA-102 in Rett Syndrome

May 2
Last Trade: 3.24 0.28 9.46

RMAT designation follows FDA’s review of available safety and efficacy data from the first three patients dosed with the low dose of TSHA-102 across both REVEAL Phase 1/2 trials (adolescent/adult and pediatric) RMAT designation enables increased dialogue with the FDA to support the potential expedited development and review of TSHA-102 in clinical evaluation for Rett syndrome DALLAS, May 02, 2024 (GLOBE NEWSWIRE) -- Taysha Gene...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


Neurocrine Biosciences Announces U.S. FDA Approval of INGREZZA® SPRINKLE (valbenazine) Capsules

April 30
Last Trade: 139.40 -1.11 -0.79

SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration...Read more


Senseonics: Eversense® CGM System Receives iCGM Designation by the US FDA

April 30
Last Trade: 0.44 -0.0051 -1.14

The first fully implantable continuous glucose monitors can now be integrated with insulin pumps as part of an automated insulin delivery system GERMANTOWN, Md. & PARSIPPANY, N.J. / Apr 30, 2024 / Business Wire / Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes and...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


Pfizer: FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer

April 29
Last Trade: 28.88 0.19 0.66

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer Conversion to full approval from accelerated approval is based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK compared to chemotherapy NEW YORK & COPENHAGEN, Denmark / Apr 29, 2024 / Business Wire / Pfizer Inc. (NYSE:...Read more


Abbott's Breakthrough Dissolving Stent Receives FDA Approval for Arteries Below the Knee

April 29
Last Trade: 103.95 -0.28 -0.27

More than 20 million people in the U.S. are living with peripheral artery disease (PAD) yet there have been limited treatment options The first-of-its-kind Esprit™ BTK Everolimus Eluting Resorbable Scaffold dissolves over time after it has opened blocked arteries below the knee (BTK) The Esprit BTK System is a dissolving stent that offers the possibility of better outcomes for people with the most severe form of PAD ABBOTT PARK,...Read more


GE HealthCare Receives FDA Clearance for Portrait VSM, Building on Its Growing Ecosystem of Connected Patient Monitoring Solutions

April 29
Last Trade: 79.85 0.52 0.66

The portable vital signs monitor (VSM) adds to GE HealthCare’s growing Portrait Ecosystem to help clinicians make timely treatment decisions and detect patient deterioration earlier with a streamlined spot check workflow, while ensuring patient mobility. Portrait VSM uses proven and innovative capabilities to provide precise readings for blood pressure, pulse rate, oxygen saturation, body temperature and respiratory rate. CHICAGO /...Read more


Soleno Therapeutics Receives Breakthrough Therapy Designation from U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome (PWS)

April 29
Last Trade: 41.16 -0.01 -0.02

First Ever Breakthrough Designation for a Drug Being Developed for PWS Designation is Based on Data from the Phase 3 Program for DCCR Planned Submission of a New Drug Application (NDA) for DCCR Remains on Track for Mid-2024 REDWOOD CITY, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare...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


ClearPoint Neuro Announces FDA Clearance of Prism Bone Anchor Accessory

April 29
Last Trade: 5.87 -0.34 -5.48

SOLANA BEACH, Calif., April 29, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its Prism Bone Anchor Accessory. This clearance marks the Company’s second new product introduction within the first four months of 2024. “Similar to the recent launch...Read more


Labcorp Receives FDA Approval for First Companion Diagnostic for Use with Pfizer's Newly Approved Gene Therapy to Treat Patients with Hemophilia B

April 29
Last Trade: 199.65 2.56 1.30

Assay expands company's leadership in precision medicine and cell and gene therapy BURLINGTON, N.C., April 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with...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


Aquestive Therapeutics Receives U.S. FDA Approval and Market Access for Libervant™ (diazepam) Buccal Film in Pediatric Patients Ages 2 to 5 and Provides Update on Anaphylm™ (epinephrine) Sublingual Film

April 29
Last Trade: 3.06 -0.01 -0.33

Libervant is the first and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients ages 2 to 5 Announces immediate availability of Libervant 5mg, 7.5mg, 10mg, 12.5mg, and 15mg for patients between 2 to 5 years of age Company track record now includes 4 FDA approvals since 2018 Anaphylm program on track; NDA submission expected by the end of 2024 Hosts conference call for investors on...Read more


X4 Pharmaceuticals Announces FDA Approval of XOLREMDI™ (mavorixafor) Capsules, First Drug Indicated in Patients with WHIM Syndrome

April 29
Last Trade: 0.90 0.003 0.33

XOLREMDI targets CXCR4 pathway dysfunction, the underlying cause of WHIM syndrome Breakthrough Therapy approval follows Priority Review of 4WHIM Phase 3 clinical trial data X4 granted Rare Pediatric Disease Priority Review Voucher (PRV) concurrent with approval Conference call and webcast to be hosted today at 8:30 am ET BOSTON, April 29, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the...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


U.S. FDA Approves Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B

April 26
Last Trade: 28.88 0.19 0.66

A one-time dose of BEQVEZ has reduced bleeds post-treatment compared to standard of care with a median of zero bleeds (range 0 to 19) after up to three years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients NEW YORK / Apr 26, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved...Read more


Gilead Sciences: FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV

April 26
Last Trade: 65.68 -0.49 -0.74

Additional Data in Pregnant Adults Who Are Virologically Suppressed Reinforce Safety and Tolerability Profile of Biktarvy in Broad Range of People With HIV Perinatal Guidelines Recognize Biktarvy as Alternative Regimen for Use During Pregnancy and for Those Trying to Conceive FOSTER CITY, Calif. / Apr 26, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an...Read more


Medtronic receives FDA approval for Inceptiv™ closed-loop spinal cord stimulator

April 26
Last Trade: 82.29 0.91 1.12

Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain DUBLIN, April 26, 2024 /CNW/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to...Read more


Compass Therapeutics Receives FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Patients with Metastatic or Locally Advanced Biliary Tract Tumors That Have Been Previously Treated

April 25
Last Trade: 1.47 -0.03 -1.67

CTX-009, the Company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel, has shown promising clinical responses in patients with advanced biliary tract cancer (BTC) in its Phase 2 study Top-line data readout for COMPANION-002, the Company’s randomized Phase 2/3 BTC U.S. study, is expected by the end of 2024 BOSTON, April 25, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage,...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


Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy

April 24
Last Trade: 5.99 -0.08 -1.32

Company Aligned with FDA on Demonstration of Non-Clinical Comparability; Allowing for Immediate Use of San Diego Manufacturing Facility FDA Feedback Supports Requests for a Pre-BLA Meeting and Subsequent Rolling BLA Submission Following Upcoming Q2 Type-B FDA Meeting Company Granted Subsequent Type-B Clinical Meeting with FDA in Second Quarter to Continue to Discuss Pathway to BLA Capricor Management to Host Virtual Investor Webcast...Read more


Amneal Pharmaceuticals Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose

April 24
Last Trade: 6.45 0.01 0.16

Company launches generic equivalent to OTC NARCAN® Nasal Spray Provides convenient, affordable access to life-saving medicine BRIDGEWATER, N.J. / Apr 24, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the availability of Over the Counter (“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following Abbreviated New Drug Application (“ANDA”) approval from...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


Medicure Receives US FDA Fast Track Designation for MC-1 for PNPO Deficiency

April 23
Last Trade: 1.09 0.04 3.81

WINNIPEG, MB / ACCESSWIRE / April 23, 2024 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC PINK:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, announced today that through its subsidiary, Medicure International Inc., the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MC-1,...Read more


Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor

April 23
Last Trade: 13.77 -0.10 -0.72

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 RAPNO LGG overall response rate (ORR) of 51% Day One receives rare pediatric disease priority review voucher Conference call and webcast to be April 24, 8:30 a.m. Eastern Time BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq:...Read more


ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

April 22
Last Trade: 6.52 -0.16 -2.40

Designated an FDA Breakthrough Therapy, the novel immunotherapy ANKTIVA activates the body’s natural killer (NK) and killer T-cell immune system to attack tumor cells Therapy stimulates memory T cells, leading to long duration of complete response exceeding 47 months and ongoing to date, with a median duration of response yet to be determined The percentage of patients with durable responses at 12 and 24 months exceeded the benchmark...Read more


Kura Oncology Receives Breakthrough Therapy Designation for Ziftomenib in NPM1-Mutant AML

April 22
Last Trade: 21.17 -0.26 -1.21

Ziftomenib is the first investigational treatment to be granted Breakthrough Therapy Designation for NPM1-mutant AML  Registration-directed trial of ziftomenib in NPM1-mutant AML on track to complete enrollment by mid-2024  SAN DIEGO, April 22, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment...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


FDA Advisory Panel Review of Guardant Health’s Shield™ Blood Test to Screen for Colorectal Cancer to Be Held on May 23

April 22
Last Trade: 25.52 3.01 13.37

PALO ALTO, Calif. / Apr 22, 2024 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration Medical Devices Advisory Committee is scheduled to review the premarket approval (PMA) application for the company’s Shield™ blood test for colorectal cancer (CRC) screening on Thursday, May 23, 2024. “We look forward...Read more


U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

April 18
Last Trade: 13.12 0.10 0.77

ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease OSAKA, Japan & CAMBRIDGE, Mass. / Apr 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance...Read more


Roche: FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

April 18
Last Trade: 31.60 -0.19 -0.60

Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC)  This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy  The National Comprehensive...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


Alvotech and Teva Pharmaceutical Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)

April 16
Last Trade: 14.19 0.61 4.49

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion...Read more


Petros Pharmaceuticals Receives Positive Response from FDA Following Recent Demonstration of Technology Component in Pursuit of OTC Status for STENDRA(R) (avanafil)

April 16
Last Trade: 0.61 -0.0035 -0.57

(Please see important safety information below) NEW YORK, NY / ACCESSWIRE / April 16, 2024 / Petros Pharmaceuticals, Inc. ("Petros," or the "Company") (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has received positive feedback from the U.S. Food and Drug Administration (the "FDA," or the "Agency") following the FDA's informal review of...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


Lexeo Therapeutics Granted FDA Fast Track Designation for LX2006, an AAV-Based Gene Therapy Candidate for the Treatment of Friedreich’s Ataxia Cardiomyopathy

April 16
Last Trade: 15.46 -0.02 -0.13

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate for the treatment of...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


FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Marburg Marburgvirus Infection

April 15
Last Trade: 0.37 0.006 1.67

Provides MarVax™ Heat Stable Vaccine Seven Years of U.S. Market Exclusivity Upon FDA Approval  PRINCETON, N.J., April 15, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United...Read more


Candel Therapeutics Receives FDA Orphan Drug Designation for CAN-2409 for the Treatment of Pancreatic Cancer

April 11
Last Trade: 7.80 -2.89 -27.03

NEEDHAM, Mass., April 11, 2024 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, for the...Read more


FDA Grants Soligenix Orphan Drug Designation for the Prevention and Post-Exposure Prophylaxis Against Sudan Ebolavirus Infection

April 11
Last Trade: 0.37 0.006 1.67

Provides SuVax™ Heat Stable Vaccine Seven Years of U.S. Market Exclusivity Upon FDA Approval PRINCETON, N.J., April 11, 2024 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products Development of the United...Read more


Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company Once approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer’s disease Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis Basel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX:...Read more


AstraZeneca: FASENRA approved for treatment of children aged 6 to 11 with severe asthma

April 11
Last Trade: 78.54 0.36 0.46

Additional indication for pediatric patients with severe eosinophilic asthma WILMINGTON, Del. / Apr 11, 2024 / Business Wire / AstraZeneca’s FASENRA® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.1 FASENRA was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic...Read more


PureTech Health Receives FDA Fast Track Designation for LYT-200 in Head and Neck Cancers

April 11
Last Trade: 29.25 0.00 0.00

LYT-200 is being evaluated in locally advanced/metastatic solid tumors, including head and neck cancers, as well as in hematological malignancies, such as acute myeloid leukemia and high-risk myelodysplastic syndrome Phase 1b and Phase 1/2 clinical trials of LYT-200 ongoing BOSTON / Apr 11, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company...Read more


Labcorp Receives FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit

April 10
Last Trade: 199.65 2.56 1.30

The first at-home mpox testing kit provides patients with convenience and privacy to test for mpox, supports physicians in detection and treatment BURLINGTON, N.C., April 10, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox  PCR Test Home...Read more


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