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FDA panel votes against controversial ALS drug candidate

FDA advisers voted against recommending an experimental treatment for Lou Gehrig s disease, or ALS, citing lack of efficacy data. ....

Lou Gehrig , Gene Therapies Advisory Committee , Amylyx Pharmaceutical Relyvrio , Lou Gehrigs Disease , Amyotrophic Lateral Sclerosis ,

US FDA flexibility the question as Nurown goes before adcom

How flexible should the U.S. FDA evidentiary standards be for a therapy addressing a significant unmet need in a disease such as amyotrophic lateral sclerosis (ALS)? That’s the question the agency’s Cellular, Tissue and Gene Therapies Advisory Committee will ponder Sept. 27 as it looks at the data for Brainstorm Cell Therapuetics Inc.’s Nurown (debamestrocel), a mesenchymal stromal cell therapy targeting ALS. ....

Brainstorm Cell Therapuetics Inc , Gene Therapies Advisory Committee , Brainstorm Cell Therapuetics , Amyotrophic Lateral Sclerosis , Brainstorm Cell Therapeutics Inc , Biogen Inc , Ionis Pharmaceuticals Inc ,

GlobalData : FDA accelerated approval of Biogen Qalsody game changer for rare subgroup of ALS patients, says GlobalData

03 May, 2023 FDA accelerated approval of Biogen Qalsody game changer for rare subgroup of ALS patients, says GlobalData

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. | May 3, 2023 ....

Barbora Salcman , Drug Administration , Neurology Analyst , Although Biogen , Amylyx Pharmaceutical Relyvrio , Globaldata Plc Stock Exchange , Press Release , Ays Data Gb00b87ztg26 ,

Biogen Drug Wins Accelerated FDA Nod for Treating Rare Genetic Form of ALS

The Biogen amyotrophic lateral sclerosis drug, Qalsody, treats patients whose disease is driven by mutations to a gene called SOD1. It’s the first drug approved to target a genetic cause of ALS. ....

Christopher Viehbacher , Ionis Pharmaceuticals , New England Journal , Amylyx Pharmaceutical Relyvrio , Weight Loss , Medical Devices , Healthcare Innovation , Medcity News , Medcity News , San Francisco , Life Sciences , Rock Health , Startup Advice , Startup Funding , Patient Monitoring System , Otion Sensors , Healthcare It , Foodborne Pathogens , Iagnostics Company , Iagnostic Platforms , Minimally Invasive Surgery , Aser Surgery , Ealth And Wellness , Mployee Wellness Programs , Hanghai Innovation Center , R D ,

FDA Grants Accelerated Approval For Biogen's ALS Drug

Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has approved Qalsody (tofersen) 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis or ALS in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. ....

Ionis Pharmaceuticals , More Such Health News , Drug Administration , Biogen Inc , Health News ,