NDA News-CliniExpert

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

FDA Approves DefenCath (taurolidine and heparin) to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients

Berkeley Heights, NJ – November 15, 2023 --  CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment o

FDA Approves Augtyro (repotrectinib) for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC)

PRINCETON, N.J.--(BUSINESS WIRE) -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for the treatment of adult patien

FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Virus

Saint-Herblain (France), November 10, 2023 -- Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved

FDA Approves Adzynma (ADAMTS13, recombinant-krhn) Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

OSAKA, Japan & CAMBRIDGE, Mass., November 09, 2023--(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Adzynma (ADAMTS13, r

FDA Approves Zepbound (tirzepatide) for Chronic Weight Management

INDIANAPOLIS, Nov. 8, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity tr