FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel) to expand its current indication to in...
FDA grants Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry solution for infants.
FDA accepts for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab-bwwd) injection 40 ...
Federal Register notice: FDA determines that Akorns Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effective...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.
