FDA approves an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease.
HHS secretary Robert F. Kennedy Jr. admits that many mistakes were made in cuts across HHS health agencies, including FDA, and that around 20% of term...
The U.S. House Committee on Oversight and Government Reform announces a 4/9 hearing on reducing inefficiencies and the bureaucracy at FDA.
CBER director Peter Marks speaks out about the pressure he faced before given the option to resign or be fired for questioning HHS secretary Robert F....
Draeger recalls its Flex 220 ID breathing circuit due to the risk of cracks forming in the breathing circuit hose.
FDA grants Ideaya Biosciences a breakthrough therapy designation for darovasertib for neoadjuvant use in adult patients with primary uveal melanoma.
FDA issues a complete response letter to Aldeyras NDA for reproxalap to treat dry eye disease, citing a lack of efficacy in the submitted trial.
FDA Webview Contributing Editor John Hope says the dismissal of agency communications staff will hurt information flow to the public.
