NDA News-CliniExpert

FDA Approves Ycanth (cantharidin) Topical Solution for the Treatment of Molluscum Contagiosum

WEST CHESTER, PA –Jul 21, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medica

FDA Approves Balfaxar (prothrombin complex concentrate, human-lans) for Warfarin Reversal in Urgent Surgery & Invasive Procedures

PARAMUS, N.J., July 26, 2023 /PRNewswire/ -- Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. F

FDA Approves Vanflyta (quizartinib) for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia

TOKYO & BASKING RIDGE, N.J. July 20, 2023 --(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that Vanflyta (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA)

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