FDA Approves Steqeyma (ustekinumab-stba), a Biosimilar to Stelara
JERSEY CITY, N.J., Dec. 17, 2024 -- Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for subc
FDA Approves Crenessity (crinecerfont) for the Treatment of Children and Adults with Classic Congenital Adrenal Hyperplasia
SAN DIEGO, Dec. 13, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved Crenessity (crinecerfont) capsules and oral solu
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
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
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
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
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
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
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
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
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
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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