FDA approves Takedas Adzynma, a recombinant protein product designed for prophylactic or on‑demand enzyme replacement therapy in both adult and ...
The CDER Office of Therapeutic Biologics and Biosimilars recommends expiration dates for first interchangeable exclusivity for Boehringer Ingelheims C...
Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effective...
CDER announces a reorganization of the Office of Pharmaceutical Quality effective 1/14/2024.
FDA tells healthcare providers about labeling updates to Becton Dickinsons (BD) Phasix and GalaFlex mesh products that discourage breast surgery use.
FDA approves a PMA for the Recor Medical Paradise renal denervation system to treat hypertension.
Becton Dickinsons CareFusion unit recalls its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible syringes labeling c...
A Lassman Law petition filed for an unidentified client asks FDA not to approve an Amryt NDA for Filsuvez to treat cutaneous manifestations of junctio...
