FDA and the Duke-Margolis Center for Health Policy announce a 6/7-8 public workshop on the agencys Rare Disease Endpoint Advancement Pilot Program.
Federal Register notice: FDA announces a 6/15 advisory committee to select strain(s) to be included in the Covid19 vaccines for the 20232024 season.
Federal Register notice: FDA creates a docket to receive public comments on the identification, assessment, and control of N-nitrosamine drug substanc...
FDA issues a complete response letter for Novo Nordisks concizumab, asking for additional dosing and manufacturing information.
FDA issues a warning on SD Biosensors Pilot Covid-19 At-Home Tests due to bacterial contamination concerns with its liquid solution.
FDA leaves a five-item Form FDA-483 after a 2/27-3/7 inspection of Rentschler Biopharmas manufacturing facility in Baden-Wurttemberg, Germany.
Rejected by FDA for accelerated approval, Lilly says it will seek the fastest traditional approval possible for its donanemab to treat early symptomat...
FDA approves a GlaxoSmithKline BLA for Arexvy (respiratory syncytial virus vaccine, adjuvanted), for preventing lower respiratory tract disease caused...
