FDA Approves Xenpozyme (olipudase alfa-rpcp) for Non-CNS Manifestations of Acid Sphingomyelinase Deficiency (ASMD)
Paris, August 31, 2022 -- The U.S. Food and Drug Administration (FDA) has approved Xenpozyme (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphi
FDA Approves Auvelity (dextromethorphan and bupropion) for the Treatment of Major Depressive Disorder in Adults
Auvelity is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week11-4 Auvelity
FDA Approves Zynteglo (betibeglogene autotemcel) Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions
SOMERVILLE, Mass.--(BUSINESS WIRE)--Aug. 17, 2022 -- bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved Zynteglo® (betibeglogene autotemcel), al
FDA Approves Cimerli (ranibizumab-eqrn), an Interchangeable Biosimilar to Lucentis
REDWOOD CITY, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has ap
FDA Approves Zoryve (roflumilast) Cream for the Treatment of Plaque Psoriasis
WESTLAKE VILLAGE, Calif., July 29, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovatio
FDA Approves Zonisade (zonisamide oral suspension) for the Treatment of Partial-Onset Seizures
The first and only FDA-approved zonisamide oral liquid formulation WOBURN, Mass., July 18, 2022 /PRNewswire/ -- Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing in
FDA Approves Bludigo (indigotindisulfonate sodium) for Cystoscopic Assessment of the Ureters Following Urological and Gynecological Surgical Procedures
Marseille, France and Collegeville, PA, USA – July 12, 2022 -- Provepharm, a French company specialized in the development of pharmaceutical applications, today announces that it has received FDA New
FDA Approves Amvuttra (vutrisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 13, 2022 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA
FDA Approves Priorix (Measles, Mumps and Rubella Vaccine, Live) for the Prevention of Measles, Mumps and Rubella in Individuals 12 Months of Age and Older
Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients London UK 06 June 2022 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (F
FDA Approves Fylnetra (pegfilgrastim-pbbk), a Biosimilar to Neulasta
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- May 27, 2022 -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has approv
FDA Approves Vtama (tapinarof) Cream for the Treatment of Plaque Psoriasis in Adults
LONG BEACH, Calif., and BASEL, Switzerland, May 24, 2022 -- Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, t
FDA Approves Mounjaro (tirzepatide) Injection for the Treatment of Adults with Type 2 Diabetes
INDIANAPOLIS, May 13, 2022 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) injection, Eli Lilly and Company's (NYSE: LLY) new once-weekly GIP (glucose-d
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