FDA Approves Elevidys (delandistrogene moxeparvovec-rokl) Gene Therapy to Treat Duchenne Muscular Dystrophy
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 22, 2023 -- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug Administra
FDA Approves Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for Subcutaneous Use in Generalized Myasthenia Gravis
SAN DIEGO, June 20, 2023 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that argenx received U.S. Food and Drug Administration (FDA) approval for Vyv
FDA Approves Lodoco (colchicine) as the First Anti-Inflammatory Drug for Cardiovascular Disease
Parsippany, NJ – June 20, 2023 -- AGEPHA Pharma USA, LLC, today announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved Lodoco® as the first anti-inflamma
FDA Approves Columvi (glofitamab-gxbm) Bispecific Antibody for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
South San Francisco, CA -- June 15, 2023 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi (
FDA Approves Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) Colonoscopy Preparation that Tastes Similar to a Sports Drink
BRAINTREE, Mass., June 22, 2023 /PRNewswire/ -- Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of Suflave™ (polyethylene glycol, sodium sulfat
FDA Approves Abrysvo (respiratory syncytial virus vaccine) for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults
NEW YORK--(BUSINESS WIRE) May 31, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Abrysvo™ (Respiratory Syncytial Virus Vaccine), the comp
FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure
THE WOODLANDS, Texas, May 26, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Inpefa™ (sotagliflozin
FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of Progression to Severe COVID-19
NEW YORK--(BUSINESS WIRE) May 25, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) for t
FDA Approves Posluma (flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE) May 30, 2023 --Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET ra
FDA Approves Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa. -- May 23, 2023 -- Braeburn announces that the U.S. Food and Drug Administration (FDA) has approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (CIII)
FDA Approves Xacduro (sulbactam and durlobactam) for the Treatment of Serious Infections Caused by Acinetobacter
WALTHAM, Mass.--(BUSINESS WIRE)--May 23, 2023 -- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that the U.S. Food and Drug Administration (FDA) approv
FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira
JERSEY CITY, N.J.--(BUSINESS WIRE) May 24, 2023 -- Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/m
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