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...
FDA warns Boston, MA-based Brigham and Womens Hospital about CGMP violations in its production of positron emission tomography drugs.
CDER launches its new Accelerate Rare disease Cures program to speed and increase the development of effective and safe treatment options for patients...
Mesa Biotech recalls its Accula SARS-CoV-2 Test because certain lots of the device have an increased risk of giving false positive results due to cont...