The Puerto Rico federal court enters a consent decree requiring Droguera Betances, one of the territorys largest pharmaceutical distributors, to pay $...
A BMJ investigation raises concerns that the federal governments vaccine adverse event system is not operating as planned and safety signals are likel...
FDA approves a Valneva Austria BLA for Ixchiq, a vaccine for preventing chikungunya in individuals aged 18 years and above who are at heightened risk ...
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel) to expand its current indication to in...
FDA grants Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry solution for infants.
FDA accepts for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab-bwwd) injection 40 ...
Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effective...
CDER announces a reorganization of the Office of Pharmaceutical Quality effective 1/14/2024.
