An FDA untitled letter cautions Evofem Biosciences that a promotional brochure for its on-demand contraceptive Phexxi overstates the products benefits...
FDA approves a Takeda Pharmaceuticals NDA for Fruzaqla (fruquintinib) for use in certain adult patients suffering from metastatic colorectal cancer.
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...
Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effective...
