Federal Register notice: FDA renews its Gastrointestinal Drugs Advisory Committee for an additional two years.
Veru says it will submit a second-quarter application to FDA for an emergency use authorization for sabizabulin to treat some hospitalized Covid-19 pa...
FDA issues Sun Pharmaceutical Industries a 10-item Form FDA-483 after conducting a 5/9-concluded inspection of its Halol facility (Gujarat, India) man...
The House Energy and Commerce Committee unanimously votes (30 to 0) to advance a legislative package that would reauthorize FDA user fees for an addit...
FDA approves an ADMA Biologics request to extend the expiration date from 24 to 36 months for Bivigam (immune globulin intravenous), indicated for tre...
CBER increases from 13 to 17 the number of guidances it expects to develop in 2022.
Former FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional congressional authorities to fully implement its ...
Federal Register notice: FDA determines that Pfizers Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectivenes...