FDA amends a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab because the 500mg therapy is unlikely to be effective in...
CDERs Office of Prescription Drug Promotion proposes to conduct a study entitled Accelerated Approval Disclosures on Direct-to-Consumer (DTC) Prescrip...
Federal Register notice: FDA withdraws approval of a Secura Bio NDA for Farydak (panobinostat) capsules after the company requested the action because...
CDRH director Jeffrey Shuren says legislation is needed to provide more regulatory flexibility and agility to deal with artificial intelligence/machin...
Former CBER Office of Vaccines Research and Review deputy director Philip Krause joins Mesoblasts board of directors and will assist the company in ga...
FDA grants a second breakthrough designation to Pfizers respiratory syncytial virus vaccine candidate, this time to prevent lower respiratory tract di...
FDA approves a label update for Janssens Cabenuva to permit starting the injection treatment without an oral treatment lead-in.
FDA sends Eli Lilly and Innovent Biologics a complete response letter on its BLA for sintilimab injection, a me-too PD-1 inhibitor for treating certai...