FDA grants HistoSonics a breakthrough device designation for its novel sonic (acoustic energy) beam therapy histotripsy and its use to mechanically de...
FDA Review posts the Federal Register notices for the week ending 10/15/2021.
FDA Review posts product approval summaries for the week ending 10/15/2021.
Lupin recalls all irbesartan and irbesartan/hydrochlorothiazide tablets after finding some active pharmaceutical ingredient batches were above the spe...
An FDA advisory committee unanimously votes to recommend Johnson & Johnsons Covid-19 booster vaccine in all adults two months after receiving their in...
FDA delays its decision on expanding a Moderna emergency use authorization for its Covid-19 vaccine in adolescents while it further investigates myoca...
Former FDA associate commissioner Peter Pitts says FDA needs a deputy commissioner for regulatory competitiveness to aggressively develop, coordinate,...