NDA News-CliniExpert

FDA Approves Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use

GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cyfendus (Anthrax Vaccine Adsor

FDA Approves Beyfortus (nirsevimab) for the Prevention of RSV Lower Respiratory Tract Disease in Infants

July 17, 2023 -- AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns

FDA Approves Opill (norgestrel) OTC Daily Oral Contraceptive

DUBLIN, July 13, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration (FDA) approved Opi

FDA Approves Roctavian (valoctocogene roxaparvovec-rvox) Gene Therapy for Adults with Severe Hemophilia A

SAN RAFAEL, Calif., June 29, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced

FDA Approves Lantidra (donislecel-jujn) Cellular Therapy to Treat Patients with Type 1 Diabetes

June 28, 2023 -- Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatm

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 (