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.
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...
FDA warns inhousepharmacy.vu that it is illegally marketing domperidone drug products in the U.S.
FDA says the Skippack Medical Laboratory recall of rapid Covid-19 tests that were not cleared, approved, or authorized is Class 1 and people should no...