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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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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FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

JERSEY CITY, N.J., May 13, 2022 /PRNewswire/ -- Mitsubishi Tanabe Pharma Corporation (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved Radicava ORS (edaravone), the oral

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