FDA Approves Wainua (eplontersen) for the Treatment of Adults with Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
U.S. FDA approval based on Phase 3 NEURO-TTRansform results showing Wainua demonstrated consistent and sustained benefit halting neuropathy disease progression and improving neuropathy impairment and
FDA Approves Filsuvez (birch triterpenes) Topical Gel for the Treatment of Epidermolysis Bullosa
BOSTON, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare disease
FDA Approves Alyglo (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)
YOGIN, South Korea, Dec. 17, 2023 /PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved Alyglo (immune globulin intravenous, human-s
FDA Approves Iwilfin (eflornithine) as Maintenance Therapy for High-Risk Neuroblastoma
LOUISVILLE, Ky.--(BUSINESS WIRE) --USWM, LLC (US WorldMeds) today announced that the U.S. Food and Drug Administration (FDA) has approved Iwilfin ™ (eflornithine) 192 mg tablets, a groundbreaking oral
FDA Approves iDose TR (travoprost intracameral implant) for the Treatment of Glaucoma
ALISO VIEJO, Calif.--(BUSINESS WIRE) December 14, 2023 -- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of
FDA Approves Casgevy (exagamglogene autotemcel) CRISPR/Cas9 Genome-Edited Cell Therapy for the Treatment of Sickle Cell Disease
BOSTON & ZUG, Switzerland--(BUSINESS WIRE)--Dec. 8, 2023 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and CRISPR Therapeutics (Nasdaq: CRSP) announced today that the U.S. Food and Drug Ad
FDA Approves Lyfgenia (lovotibeglogene autotemcel) for Patients Ages 12 and Older with Sickle Cell Disease and a History of Vaso-Occlusive Events
SOMERVILLE, Mass.--(BUSINESS WIRE)--Dec. 8, 2023 -- bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird bio” or “bluebird”) today announced the U.S. Food and Drug Administration (FDA) has approved Lyfgenia (
FDA Approves Avzivi (bevacizumab-tnjn), a Biosimilar to Avastin
GUANGZHOU, China, Dec. 7, 2023 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets, today anno
FDA Approves Fabhalta (iptacopan) for the Treatment of Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Basel, December 6, 2023 -- Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with parox
FDA Approves Ogsiveo (nirogacestat) for Adults with Desmoid Tumors
STAMFORD, Conn., Nov. 27, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced tod
FDA Approves Truqap (capivasertib) plus Faslodex for Patients with Advanced HR-Positive Breast Cancer
17 November 2023 -- AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive,
FDA Approves Ryzneuta (efbemalenograstim alfa) for Chemotherapy-Induced Neutropenia
November 22, 2023, New Jersey -- Evive Biotech (Evive), a global biopharmaceutical company devoted to developing novel biologic therapies and a subsidiary of Yifan Pharmaceutical Co. Ltd., and Acrotec
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