Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial Company to host investor webcast on Dec. 11, 2024 For U.S. media and investors only DUBLIN, Nov....Read more
New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses. GALWAY, Ireland, Nov. 20, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for...Read more
Sangamo plans to initiate enrollment of patients in the Phase 1/2 study for ST-503 in mid-2025 RICHMOND, Calif. / Nov 19, 2024 / Business Wire / Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for its ST-503 program, an investigational epigenetic regulator for the treatment of intractable...Read more
Phase 1b study for the potential treatment of osteoarthritis and low back pain expected to commence in the first quarter of 2025 Initial data readout planned for early 2026 Neuropathic component of chronic pain linked to LPA1 activation SAN DIEGO / Nov 18, 2024 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical stage biopharmaceutical company focused on discovering and developing...Read more
The New Drug Application is based on positive results from the Phase 3 PALISADE study People living with familial chylomicronemia syndrome have extremely high triglyceride levels and a substantially higher risk of developing acute pancreatitis and associated long-term complications, including poor quality of life There are currently no FDA approved therapies to treat familial chylomicronemia syndrome PASADENA, Calif. / Nov 18, 2024 /...Read more
PDUFA Date is April 2, 2025 LEXINGTON, Mass. / Nov 18, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a...Read more
Northvale, New Jersey--(Newsfile Corp. - November 18, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of 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 a generic version of Vyvanse® (Lisdexamfetamine...Read more
Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation Syndax to host conference call today at 6:00 p.m. ET WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the...Read more
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade TARRYTOWN, N.Y. and PARIS, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:...Read more
Only Device Approved to Deliver First Disease-Modifying Treatment for AADC Deficiency in the United States SOLANA BEACH, CA / ACCESSWIRE / November 13, 2024 / ClearPoint Neuro, Inc. (Nasdaq:CLPT) (the "Company"), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the SmartFlow Neuro Cannula using...Read more
First-ever FDA approval for gene therapy directly administered to the brain Priority review voucher granted Broad label including children and adults PTC pioneers new approach for CNS drug delivery WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the...Read more
New MRI technology aims to advance neuroimaging and biomarker research CHICAGO / Nov 13, 2024 / Business Wire / GE HealthCare (Nasdaq: GEHC) has received FDA 510(k) clearance for its innovative SIGNA™ MAGNUS,i a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This system offers new capabilities for both clinical imaging and neuroscience with the potential to aid in the detection of neurological, oncological,...Read more
Ewing Sarcoma is a Highly Metastatic Form of Sarcoma and the Second Most Prevalent Primary Malignant Tumor in Children and Adolescents Ongoing Enrollment in Phase 1/2 Trial of Elraglusib in Relapsed/Refractory Ewing Sarcoma with Topline Phase 1 Data Expected in 2H 2025 Rare Pediatric Disease Designation Provides Eligibility for Elraglusib to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be either Utilized or...Read more
NASHUA, N.H., Nov. 12, 2024 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”) a global leader in clinically proven AI-powered cancer detection solutions, announced today that its ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) has received clearance from the U.S. Food and Drug Administration (FDA). This next-generation AI solution, trained using advanced deep learning convolutional neural...Read more
CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for recessive dystrophic epidermolysis bullosa (RDEB). The FDA has assigned a...Read more
VAX-31 Infant Indication: Investigational New Drug Application Cleared by FDA; Company Expects to Initiate VAX-31 Infant Phase 2 Study by the End of January 2025 VAX-31 Adult Indication: Breakthrough Therapy Designation Granted by FDA; Company Plans to Initiate Adult Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 VAX-31, Designed to Cover Currently Circulating and Historically Prevalent Strains, is Being Studied for the...Read more
BOULDER, CO / ACCESSWIRE / November 11, 2024 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received...Read more
FDA sets PDUFA Action Date of June 28, 2025 Company Preparing for 2025 Commercial Launch LOS ALTOS, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for...Read more
AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy) Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALL Conference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) --...Read more
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and...Read more
FDA decision on marketing authorization expected in the first quarter of 2025 CAESAREA, Israel, Nov. 8, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee...Read more
MB-108 (HSV-1 oncolytic virus) is active and well tolerated in patients with recurrent glioblastoma in ongoing Phase 1 clinical trial Preclinical data support a novel combination of MB-108 (HSV-1 oncolytic virus) and MB-101 (IL13Rα2‐targeted CAR-T cell therapy) to optimize clinical results WORCESTER, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage...Read more
NASHVILLE, Tenn., Nov. 6, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, announced today that the United States (U.S.) Food and Drug Administration (FDA) granted Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Cumberland is completing the FIGHT DMD™ trial, a...Read more
This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the receipt of a Breakthrough Device Designation from the U.S. Food and Drug...Read more
Canalevia®-CA1 is the first and only treatment for chemotherapy-induced diarrhea (CID) in dogs to receive any type of approval from the FDA By prescription only, Canalevia-CA1 is a canine-specific formulation of crofelemer, Jaguar's novel, oral plant-based product sustainably harvested from the Croton lechleri tree SAN FRANCISCO, CA / ACCESSWIRE / November 6, 2024 / Jaguar Health, Inc.(NASDAQ:JAGX), under its Jaguar Animal Health...Read more
Donidalorsen will be a first-in-class RNA-targeted medicine for hereditary angioedema, assuming approval Donidalorsen PDUFA date set for August 21, 2025 Donidalorsen has the potential to be Ionis' second independent commercial launch CARLSBAD, Calif., Nov. 4, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug...Read more
SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release...Read more
Germantown, Maryland, and Venlo, the Netherlands, Nov. 04, 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 Meningitis/Encephalitis Panel for clinical use. This marks the fourth QIAstat-Dx syndromic test to receive U.S. regulatory clearance in 2024. Meningitis (inflammation of the membrane surrounding the brain and...Read more
The Acclaim® Fully Implanted Cochlear Implant is differentiated from existing cochlear implants and may offer new option for hearing loss patients WHITE BEAR LAKE, Minnesota, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announces that its Investigational Device Exemption (IDE) application for its pivotal...Read more
Recurrent low-grade serous ovarian cancer is a rare cancer with no FDA-approved treatments Company seeking accelerated approval and priority review of its NDA submission in patients with KRAS mutant low-grade serous ovarian cancer; FDA filing decision expected before the end of 2024 with potential for FDA approval decision by mid-2025 BOSTON / Oct 31, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company...Read more
THE WOODLANDS, Texas, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the outcome of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1...Read more
Zio AT device, along with the Zio ECG Utilization Software (ZEUS) (K222389), enables the provision of ambulatory Mobile Cardiac Telemetry (MCT) monitoring service for non-critical care patients FDA 510(k)-cleared enhancements will be available in 2025 SAN FRANCISCO, Oct. 30, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect,...Read more
WARREN, N.J., Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). "The NDA acceptance for review is a significant milestone that brings us one step closer to providing this important...Read more
SHANGHAI, China & JERSEY CITY, N.J. / Oct 30, 2024 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab). Denosumab has been approved in various countries and regions under different trade names for a range of different indications,...Read more
Successful end of Phase II meeting with FDA leading to an agreed path forward to NDA upon completion of Phase III trials for blockbuster product candidate, SP-103, for the treatment of chronic neck pain associated with muscle spasms. SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain. It is estimated that the U.S. low back and neck pain...Read more
Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies1-3 Patients on Scemblix also had fewer dose reductions and half the rate of adverse reactions leading to treatment discontinuation1-3 Nearly 50% of CML patients do not meet efficacy milestones (MMR) with current SoC and almost 25% discontinue...Read more
RMAT Designation Follows Positive Proof-of-Concept Data from the ALLO-316 TRAVERSE Trial in Adult Patients with Advanced or Metastatic CD70 Positive Renal Cell Carcinoma (RCC) Who Received Prior Immune Checkpoint Inhibitor and VEGF-Targeting Therapy ALLO-316 Advances Scientific Understanding and Applicability of the Dagger® Technology as the Next-Generation Allogeneic Platform to Maximize the Potential of a Single Infusion of an...Read more
Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasis Grifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global...Read more
CLEVELAND, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or Agency) for prademagene zamikeracel (pz-cel), its investigational autologous cell-based gene therapy, as a potential new treatment for patients with recessive dystrophic epidermolysis bullosa (RDEB). “We have worked...Read more
Encinitas, California--(Newsfile Corp. - October 29, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced it received regulatory approval to initiate a Phase 2 clinical trial to investigate KIO-301 for vision restoration in patients with retinitis pigmentosa. The ABACUS-2 trial will be a 36 patient, multi-center, double-masked, randomized, controlled, multiple dose study enrolling patients with...Read more
Germantown, Maryland, and Venlo, the Netherlands, Oct. 29, 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 Mini test for clinical use. It is the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024. The QIAstat-Dx Respiratory Panel Mini is designed to support clinical decision...Read more
TYRA-300 is the first oral FGFR-3 selective inhibitor to be well-tolerated in clinical studies First child with achondroplasia expected to be dosed in Q1 2025 CARLSBAD, Calif., Oct. 28, 2024 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR)...Read more
IDE275 (GSK959) development is progressing into First-in-Human Phase 1 clinical trial(s) for the treatment of MSI-High solid tumors, representing IDEAYA's 5th potential first-in-class clinical program MSI-High prevalence in endometrial, colorectal, and gastric cancers is ~31%, 20%, and 19%, respectively, highlighting the market potential of IDE275 (GSK959) IDEAYA to receive a $7 million payment for IND acceptance, and potential future...Read more
ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™...Read more
PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Estradiol Gel, 0.06%. ANI’s Estradiol Gel, 0.06% is the generic version of the reference listed drug (RLD) EstroGel® Gel, 0.06%. "With the FDA approval and...Read more
First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter Highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve Now with two pulsed field ablation (PFA) offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today GALWAY,...Read more
Phase 3 Studies on the Horizon in both PNH and C3G SEATTLE / Oct 24, 2024 / Business Wire / Omeros Corporation today announced that zaltenibart (OMS906) has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the treatment of complement 3 glomerulopathy (C3G), an ultra-rare, progressive renal disorder primarily afflicting children and young adults. Caused by dysregulation of the...Read more
NATICK, Mass. / Oct 23, 2024 / Business Wire / Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the submission of the first three modules of its premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for the Allurion Balloon. The Company expects to file the fourth and final module of the PMA containing the clinical data from its AUDACITY trial early next...Read more
TORONTO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October...Read more
First and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50 Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV NEW YORK / Oct 22, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial Virus Vaccine), the company’s bivalent...Read more
Company to conduct a Phase 1 Drug-Drug Interaction Study Phase 2 filing on track for Q1 2025 SOUTH SAN FRANCISCO, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the...Read more
Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024 SELARSDI’s U.S. launch for all indications is expected in Q1 2025 REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024...Read more
PRINCETON, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced the U.S. Food and Drug Administration (FDA) has accepted its De Novo medical device application for DrugSorb™-ATR and initiated substantive review. The goal of DrugSorb-ATR, an investigational medical...Read more
SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and prevent disease, announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for its 510(k) submission related to prior design changes made to the Zio AT device via letter to file. Zio AT remains commercially...Read more
Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal’s GRANDE® drug delivery technology Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) BRIDGEWATER, N.J. / Oct 21, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq:...Read more
Remain on track to initiate registrational THRIVE-3 trial in 1Q’ 2025 NEW YORK, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Intravenous (IV) Choline Chloride, the Company’s investigational IV...Read more
SAN DIEGO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for LNZ100 for the...Read more
The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines, Frown Lines, Crow's Feet Lines, and Now Platysma Bands in Adults1-5 With this Approval, BOTOX® Cosmetic is the First and Only Aesthetic Neurotoxin Product to Temporarily Improve the Appearance of Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) in...Read more
The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. As the leader in companion diagnostics, Roche continues to build on its commitment...Read more
LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to...Read more
VYALEV™ is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease Adults treated with VYALEV reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa1 VYALEV allows for personalized dosing based on individual needs, morning, day and night NORTH CHICAGO, Ill.,...Read more
US FLUBLOK label1 updated to incorporate new safety study in pregnant individuals New safety data involving more than 48,000 pregnant individuals published in American Journal of Obstetrics and Gynecology (AJOG) Global Reports Recombinant or inactivated flu vaccines are recommended by the U.S. Centers for Disease Control and Protection (CDC), Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians and...Read more
NDA based on two Phase 3 studies of TNX-102 SL in fibromyalgia with statistically significant results on the primary endpoint of reducing widespread pain; generally well tolerated TNX-102 SL is a non-opioid, centrally acting analgesic, granted Fast Track designation by FDA Fibromyalgia affects more than 10 million adults in the U.S. who are mostly women If approved by FDA, TNX-102 SL would be the first member of a new class of...Read more
ADI-001 clinical development program now addresses six autoimmune diseases Patient enrollment for idiopathic inflammatory myopathy and stiff person syndrome cohort expected to be initiated in the first quarter of 2025 Company plans to report initial clinical data from Phase 1 study in multiple autoimmune diseases in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Oct 16, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq:...Read more
CLN-978 is the first development stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application...Read more
The first treatment of its kind for metastatic NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who progressed on or after a platinum-based regimen Results of the pivotal Phase 3 LUNAR trial represent the first substantial improvement in median overall survival in more than 8 years for this patient population Optune Lua is a wearable treatment that...Read more
PDUFA goal date set for June 13, 2025 UGN-102 would be the first FDA-approved medicine for LG-IR-NMIBC, if approved PRINCETON, N.J. / Oct 15, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for...Read more
Fast Track Designation is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. Fast Track Designation for LP-184 (STAR-001) recognizes Glioblastoma (GBM) as a serious condition impacting more than 13,000 U.S. adults each year and approximately 300,000 globally. A phase 1b/2a clinical trial for recurrent GBM is targeted to start in late 2024/early 2025. LP-184, which will be...Read more
GPS Currently Investigated in Phase 3 REGAL Trial in Adult AML Patients – Interim Analysis Anticipated in Q4 2024 RPDD Provides Eligibility for GPS to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties Recent Valuations for PRVs Remain Attractive (~$100 million/each) NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS)...Read more
Immuneering recently announced positive initial Phase 2a data, including complete and partial responses, with IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients Initial data from at least one additional arm of the Phase 2a portion of the Company’s Phase 1/2a trial is expected by year-end CAMBRIDGE, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a...Read more
VAUGHAN, Ontario / Oct 14, 2024 / Business Wire / Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that the U.S. Food and Drug Administration has approved the enVista® Envy™ full range of vision intraocular lens (IOL), which offers a continuous range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL...Read more
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis and on-demand treatment in eligible patients with hemophilia A or B without inhibitors In the U.S., HYMPAVZI is the first once-weekly subcutaneous prophylactic treatment for eligible people living with hemophilia B, and the first to be administered via a pre-filled pen or syringe for eligible people living with...Read more
Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis Itovebi is...Read more
Designation based on positive interim analysis of Phase 2b VANTAGE study FOSTER CITY, Calif. / Oct 10, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to volixibat as a potential treatment for cholestatic pruritus in patients with primary biliary cholangitis (PBC). The regulatory designation is based on the...Read more
Company Plans to Complete Rolling BLA Submission by End of 2024; Application May be Eligible for Priority Review by FDA SAN DIEGO, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today that it has initiated its rolling submission process with the U.S. Food and Drug Administration...Read more
Designation is based on data from the clinical development program which demonstrated clinical proof of concept Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development FDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or...Read more
sNDA is Based on Full Findings from the Positive HELIOS-B Phase 3 Study Priority Review Voucher Utilized to Accelerate Review Period Alnylam to Host and Webcast TTR Investor Day Event Today in New York City CAMBRIDGE, Mass. / Oct 09, 2024 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the submission of its supplemental New Drug Application...Read more
KT-621 has demonstrated dupilumab-like activity and was well tolerated in a wide variety of preclinical models of TH2 diseases KT-621 is expected to start Phase 1 in October, with Phase 1 data in the first half of 2025 WATERTOWN, Mass., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein...Read more
RAMAT GAN, Israel, Oct. 09, 2024 (GLOBE NEWSWIRE) -- 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 announced the Company’s oncology drug candidate, Namodenoson, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the indication of pancreatic cancer,...Read more
Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory...Read more
Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lamp Supplemental New Drug Application (sNDA) supported by two Phase 1 safety studies AK is the second most common diagnosis made by dermatologists in the United States1 An estimated 13 million treatments given each year for AK in the US2 WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) --...Read more
NOVATO, Calif., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for setrusumab (UX143) as a treatment to reduce the risk of fracture associated with osteogenesis imperfecta (OI) Type...Read more
Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first and only canine oral parasiticide to protect against six parasites, including fleas, ticks, heartworms, roundworms, hookwormsii and three different species of tapeworm that other brands skip creating a gap in coverageiii Warming temperatures and changing consumer habits have increased parasite pressure and spread across geographies,...Read more
Cologuard Plus™ test raises the performance bar with sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025 MADISON, Wis. / Oct 04, 2024 / Business Wire /...Read more
Approval is based on the CheckMate-77T trial, in which the Opdivo-based regimen demonstrated significantly longer event-free survival compared to the chemotherapy and placebo arm; a high pathologic complete response rate was also observed1 Opdivo is the only approved PD-1 inhibitor for resectable NSCLC in both a neoadjuvant-only regimen and as part of a perioperative treatment regimen1 This milestone adds to Bristol Myers Squibb’s...Read more
Based on ECHO Phase III trial which demonstrated CALQUENCE combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy Submission to be reviewed under Project Orbis WILMINGTON, Del. / Oct 03, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult...Read more
LEXINGTON, Mass. / Oct 03, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment...Read more
First program to combine Recursion’s end-to-end suite of AI-enabled active learning modules, resulting in target identification to IND enabling studies in under 18 months Plan to initiate dosing of Phase 1/2 in Q4 2024 to evaluate REC-1245 in a biomarker enriched patient population, including patients with solid tumors and lymphoma SALT LAKE CITY, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Recursion (NASDAQ: RXRX), a leading clinical stage...Read more
WARREN, N.J., Oct. 1, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of pediatric and adult patients living with phenylketonuria (PKU). A Prescription Drug User Fee Act (PDUFA) target action date is expected to be provided in the Day 74 Letter. "The FDA filing acceptance for sepiapterin is a critical milestone...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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