FDA advises manufacturers that they should develop vaccines with a monovalent XBB.1.5 composition, according to a notice posted one day after an advis...
Reps. Schiff and Kuster introduce legislation to direct FDA to establish a process to allow generic drug manufacturers to update drug labeling with ne...
FDAs Vaccines and Related Biological Products Advisory Committee votes 21 to 0 that the Covid-19 vaccination program for the 2023-2024 season should c...
FDA researchers discuss ways to improve the use of AI/ML in precision medicine.
Corvus Pharmaceuticals seeks a 3rd quarter meeting with FDA to discuss a Phase 3 trial for its investigational cancer drug CPI-818.
Harvard Medical School professor Jerry Avorn says FDA needs to take a nonbinary approach to some drug approvals with a conditional approval for margin...
FDA clears a Phase 3 protocol amendment to allow a time-based analysis of Glycomimetics uproleselan if sufficient survival events for an event-driven ...
Public Citizens Health Research Group urges FDA to not grant accelerated approval to Sarepta Therapeutics gene therapy SRP-9001 for treating ambulator...
