As the FDA transitions out of COVID-19 crisis mode, its chief of staff Julie Tierney says the agency is looking to ramp up its hiring and retention efforts.
FDA warns about unauthorized versions of Ozempic and Wegovy amid shortage
Pending results of a CDC adcomm meeting, Pfizer said it anticipates vaccine supply availability in Q3 2023 ahead of the start of the 2023/24 RSV season this fall.
Elon Musk’s Neuralink clears FDA hurdle, gears up for human trials
The procedural ruling granted the temporary stays requested by the federal government and keeps mifepristone available while the lawsuits proceed in the lower courts.
After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
In the wake of recent deaths from bacteria-tainted eyedrops, a ProPublica analysis of FDA data reveals that the agency inspected only 6% of the overseas plants where drugs and their ingredients are produced in 2022.
FDA rebuffs Eli Lilly’s ulcerative colitis drug mirikizumab over manufacturing concerns
The Biden administration asks Supreme Court to intervene in ruling restricting mifepristone; FDA was leaning toward rejecting Sarepta’s gene therapy for Duchenne muscular dystrophy; Merck eyes sale of pigments division.