United States Food and Drug Administration

Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity

1 week ago talkbio0Tagged Approved, concerns, COVID19 (disease), delays, Intact, Interferes with, Novavax, political, Regulation of biological process, United States Food and Drug Administration, Vaccines

Novavax; FDA approval; COVID-19 vaccine; regulatory process; integrity concerns; delays; political interference

FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy

1 week ago talkbio0Tagged ELEVIDYS, Evaluation, gene therapy, Liver, Liver Failure, Acute, Muscular Dystrophy, Duchenne, patient deaths, regulatory, Toxicity aspects, Unable to walk (finding), United States Food and Drug Administration

FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients

Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

1 week ago talkbio0Tagged ARROS-1 trial, Frequency of Responses, Metastatic malignant neoplasm to brain, Neoplasms, Non-Small Cell Lung Carcinoma, Nuvalent, Protein-tyrosine kinase inhibitor, ROS1-positive Lung Cancer, Submission, United States Food and Drug Administration, zidesamtinib

Nuvalent; ROS1-positive lung cancer; zidesamtinib; FDA submission; ARROS-1 trial; NSCLC; tyrosine kinase inhibitor; objective response rate; brain metastases; oncology

FDA Acting CDER Head Jacqueline Corrigan-Curay to Retire Amid Leadership Turnover

2 weeks ago talkbio0Tagged agency departures, CDER, Drug Regulations, Jacqueline Corrigan-Curay, Leadership, Personnel Turnover, Retirement, United States Food and Drug Administration

FDA; Jacqueline Corrigan-Curay; CDER; retirement; leadership turnover; drug regulation; agency departures

Compass Pathways Achieves Phase 3 Win for Psilocybin in Depression, Yet Stock Tumbles

2 weeks ago talkbio0Tagged Clinical Trials, COMP360, Compass Pathways, Investor Reaction, Mental Depression, Psilocybin, Stock Decline, treatment-resistant depression, United States Food and Drug Administration

Compass Pathways; COMP360; psilocybin; Phase 3 trial; depression; treatment-resistant depression; clinical trial; stock decline; investor reaction; FDA