FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent year...
FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.
FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in place for the devices....
FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.
FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with ventilator systems imported from China.
FDA warns AseptiKits it is manufacturing and marketing adulterated and misbranded PALA Your Tears medical devices.
FDA approves PharmaEssentias BESREMi injection pen to treat polycythemia vera.
A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of the agency's most s...
