United States Food and Drug Administration
FDA Rejects Capricor’s Cell Therapy for Duchenne Muscular Dystrophy
FDA rejection; Capricor Therapeutics; deramiocel; Duchenne muscular dystrophy; DMD; cell therapy; cardiomyopathy; clinical data; Phase 3 HOPE-3 trial; Complete Response Letter
Moderna’s COVID Vaccine Wins FDA Approval for At-Risk Young Children
Moderna; FDA approval; COVID vaccine; children; at-risk; Spikevax; underlying conditions; full approval
FDA Commissioner Makary Proposes Fast-Track Drug Review Vouchers Tied to Lower US Prices, Without Detailing Criteria
FDA; Makary; national priority review vouchers; drug pricing; fast-track approval; price parity; pilot program
FDA Approves Updated Dosing for Lilly’s Kisunla to Lower Brain Swelling Risk
FDA; Kisunla; Eli Lilly; Alzheimer’s disease; dosing regimen; brain swelling; ARIA; safety; label update; TRAILBLAZER-ALZ 6
Novavax Approval Process Raises Concerns Among Former Regulators About FDA Integrity
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
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
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
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
Compass Pathways; COMP360; psilocybin; Phase 3 trial; depression; treatment-resistant depression; clinical trial; stock decline; investor reaction; FDA
Gilead Wins Groundbreaking FDA Approval for Twice-Yearly HIV Prevention Shot
Gilead; FDA approval; lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; long-acting injectable; WHO guidelines