FDA Grants Accelerated Approval to Bizengri (zenocutuzumab-zbco) for NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) [Merus, the Company, we, or our], a clinical-stage oncology company developing innovative, fu

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FDA Approves Yesintek (ustekinumab-kfce), a Biosimilar to Stelara

Bengaluru, Karnataka, India, December 01, 2024 -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced toda

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FDA Approves Attruby (acoramidis) to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CM

PALO ALTO, Calif., Nov. 22, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a new type of biopharmaceutical company focused on genetic diseases, today announc

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FDA Approves Imkeldi (imatinib) Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers

CAMBRIDGE, Mass.-- November 25, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the FDA has approved Imkeldi (imatinib) oral solution, the firs

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FDA Grants Accelerated Approval to Ziihera (zanidatamab-hrii) for the Treatment of HER2-Positive Biliary Tract Cancer

DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL fo

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FDA Approves Revuforj (revumenib) for the Treatment of Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation

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 first and

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FDA Approves Kebilidi (eladocagene exuparvovec-tneq) Gene Therapy for the Treatment of AADC Deficiency

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

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FDA Approves Aucatzyl (obecabtagene autoleucel) for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early-commercial stage biopharmaceutical company developing next-generation programmed T cell therapies, today ann

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FDA Approves Emrosi (minocycline hydrochloride) for the Treatment of Rosacea

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 mar

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FDA Approves Orlynvah (sulopenem etzadroxil and probenecid) for the Treatment of Uncomplicated Urinary Tract Infections

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 a

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FDA Approves Vyloy (zolbetuximab-clzb) for the Treatment of Advanced Gastric and GEJ Cancer

TOKYO, Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has appro

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FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease

NORTH CHICAGO, Ill., Oct. 17, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa) as the first

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