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 ...
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 ...
