Federal Register notice: FDA denies a debarment hearing request from Marwan Massouh and issues an order debarring him for three years from providing ...
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...
Eisai files a rolling BLA submission under the accelerated approval pathway for its investigational anti-amyloid beta protofibril antibody lecanemab (...
FDA warns Boston, MA-based Brigham and Womens Hospital about CGMP violations in its production of positron emission tomography drugs.