Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effective...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.
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...
