FDA revises the indication for Mercks Keytruda and approves a companion diagnostic test.
FDA clears an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency use in 2021.
Federal Register notice: FDA classifies the container system for the processing and storage of red blood cell components under reduced oxygen conditio...
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...
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...
