United States Food and Drug Administration – Page 7

Sarepta Reports Third Patient Death in Gene Therapy Studies for Limb-Girdle Muscular Dystrophy

1 month ago talkbio0Tagged AAVS1 gene, ELEVIDYS, gene therapy, Liver Failure, Acute, Muscular Dystrophies, Limb-Girdle, Patient Death, Safety, Study on Hold, United States Food and Drug Administration, vector

Sarepta Therapeutics; limb-girdle muscular dystrophy; SRP-9004; gene therapy; patient death; acute liver failure; FDA clinical hold; AAV vector; Elevidys; safety concerns

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

1 month ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma

Pfizer Warns of ‘Near-Term Stock Out’ of Penicillin Used for Treating Syphilis in Pregnant Women After Recall

1 month ago talkbio0Tagged Bicillin L-A, Drug Shortage, Extencilline, penicillin recall, Pfizer, Pregnant Women, public health medicine (field), syphilis treatment, Syphilis, Congenital, United States Food and Drug Administration

Pfizer; penicillin recall; Bicillin L-A; syphilis treatment; pregnant women; drug shortage; congenital syphilis; FDA; Extencilline; public health

FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

1 month ago talkbio0Tagged Advisory Committees, Clinical Trials, drug safety, Eye, Multiple Myeloma, ODAC, SmithKline Beecham, Toxicity aspects, United States Food and Drug Administration, vote

FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials

CDER Employees Leave FDA in Droves Amid HHS Overhaul

1 month ago talkbio0Tagged CDER, Employee, Health Policy, HHS Overhaul, Jr., layoffs, resignations, restructuring, Robert F. Kennedy, United States Food and Drug Administration

CDER; FDA; HHS overhaul; employee resignations; layoffs; health policy; restructuring; Robert F. Kennedy Jr.

FDA Flags Eye Safety Concerns as GSK Seeks Blenrep’s US Return

1 month ago talkbio0Tagged Advisory Committees, Blenrep, Drug Approval, Eye, Eye safety, Multiple Myeloma, relapsed/refractory multiple myeloma, SmithKline Beecham, Toxicity aspects, United States, United States Food and Drug Administration

GSK; Blenrep; FDA; eye safety; ocular toxicity; advisory committee; multiple myeloma; drug approval; United States; relapsed/refractory multiple myeloma