FDA issues Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP defic...
Public Citizen petitions FDA to contraindicate the use of Provigil (modafinil) and Nuvigil (armodafinil) during pregnancy because they are allegedly l...
AstraZeneca and Handa Pharmaceuticals agree to pay $51.4 million to resolve allegations they participated in a pay-for-delay scheme to block generic S...
FDA grants BiVACOR a breakthrough device designation for its titanium Total Artificial Heart.
HHS terminates a late-stage grant award to Moderna for developing a vaccine candidate targeting the H5 bird flu.
Attorney Nathan Downing says medical product companies should review their professional promotions as strictly as they review direct-to-consumer mater...
Merck and Daiichi Sankyo say they have withdrawn their BLA for the lung cancer drug patritumab deruxtecan.
Eight congressional Democrats call on FDA to eliminate its new limits on Covid-19 vaccines.
