NDA News-CliniExpert

FDA Approves Ngenla (somatrogon-ghla) Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

NEW YORK & MIAMI--(BUSINESS WIRE) June 28, 2023 -- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved Ngenla (

FDA Approves Rystiggo (rozanolixizumab-noli) for the Treatment of Adults with Generalized Myasthenia Gravis

Brussels (Belgium) June 27 2023 -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced Rystiggo® (rozanolixizumab-noli)* has been approved by the U.S. Food and Drug Admin

FDA Approves Litfulo (ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata

NEW YORK--(BUSINESS WIRE) June 23, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Litfulo™ (ritlecitinib), a once-daily oral treatment, f

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