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 (...
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Federal Register notice: FDA determines that Pfizers Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectivenes...
Federal Register notice: FDA makes available a draft guidance entitled Benefit-risk Considerations for Product Quality Assessments.
FDA warns Boston, MA-based Brigham and Womens Hospital about CGMP violations in its production of positron emission tomography drugs.