[ Price : $8.95]
FDA accepts for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab...[ Price : $8.95]
Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to...[ Price : $8.95]
CDER announces a reorganization of the Office of Pharmaceutical Quality effective 1/14/2024.[ Price : $8.95]
FDA tells healthcare providers about labeling updates to Becton Dickinsons (BD) Phasix and GalaFlex mesh products that discourage ...[ Price : $8.95]
An FDA untitled letter cautions Evofem Biosciences that a promotional brochure for its on-demand contraceptive Phexxi overstates t...[ Price : $8.95]
FDA approves a Takeda Pharmaceuticals NDA for Fruzaqla (fruquintinib) for use in certain adult patients suffering from metastatic ...[ Price : $8.95]
FDA revises the indication for Mercks Keytruda and approves a companion diagnostic test.[ Price : $8.95]
FDA clears an ACON Laboratories 510(k) for its Flowflex Covid-19 Antigen Home Test, which was originally authorized for emergency ...