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FDA Grants Accelerated Approval for Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis Associated with a Mutation in the SOD1 Gene

CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has approved Qalsody (tofersen) 100 mg/15mL injection f

FDA Approves Omisirge (omidubicel-onlv) Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell Transplantation

BOSTON--(BUSINESS WIRE)--Apr. 17, 2023 -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the U.S. Food and Drug Administ

FDA Approves RizaFilm (rizatriptan) Oral Film for the Treatment of Acute Migraine

SAINT LAURENT, Quebec, April 17, 2023 (GLOBE NEWSWIRE) -- Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today announced that the U.S

FDA Approves Joenja (leniolisib) for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)

LEIDEN, The Netherlands, March 24, 2023 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Dr

FDA Approves Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)

WILMINGTON, Del.--(BUSINESS WIRE)--Mar. 22, 2023 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz (retifanlimab-dlwr), a humanized monoclonal

FDA Approves Rezzayo (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis

SAN DIEGO & PARSIPPANY, N.J.--(BUSINESS WIRE)-- March 22, 2023 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration

FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome

SAN DIEGO–(BUSINESS WIRE)–Mar. 10, 2023 -- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatme

FDA Approves Zavzpret (zavegepant) Nasal Spray for the Acute Treatment of Migraine

NEW YORK--(BUSINESS WIRE) March 10, 2023 -- Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved Zavzpret (zavegepant), the first and only calcitonin gene-r

FDA Approves Skyclarys (omaveloxolone) for the Treatment of Friedreich’s Ataxia

PLANO, Texas--(BUSINESS WIRE) February 28, 2023 -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” “our,” “us,” or “we”), a biopharmaceutical company focused on developing and comm

FDA Approves Altuviiio ([Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]) Once-Weekly VIII Therapy for Hemophilia A

Paris and Stockholm – February 23, 2023 – The U.S. Food and Drug Administration (FDA) has approved Altuviiio™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referre

FDA Grants Accelerated Approval to Filspari (sparsentan) for the Reduction of Proteinuria in IgA Nephropathy

First single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients with IgA nephropathy (IgAN) Interim results from the ongoing Phase 3 PROTECT head-to-head tri

FDA Approves Syfovre (pegcetacoplan injection) for the Treatment of Geographic Atrophy, a Leading Cause of Blindness

WALTHAM, Mass., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug