FDA safety reviewers raise some concern with a Janssen Biotech BLA for Plivensia (sirukumab) injection going before the agencys Arthritis Advisory Com...
FDAs Vaccines and Related Biological Products Advisory Committee votes 12 to 1 to recommend approval of a Dynavax Technologies BLA for Heplisav-B [hep...
A White House-commissioned report urges President Trump to declare a national emergency in order to deal with the ongoing opioid crisis.
ICU Medical recalls one lot of 0.9% sodium chloride injection, USP 1,000 mL due to a confirmed customer complaint of particulate matter identified as ...
FDA clears an Immunalysis 510(k) for the Sefria Fentanyl Urine Enzyme Immunoassay for the qualitative detection of fentanyl in urine.
FDA Review posts the Federal Register notices for the week ending 7/28/2017.
Apace Packaging recalls one lot of cyclobenzaprine HCl tablets, USP 5 mg 50ct unit dose, and one lot of amantadine HCl capsules, USP 100 mg 50ct unit ...
FDA approves a Bracco Diagnostics PMA for Aribar Nectar (barium sulfate) oral suspension for use in modified barium swallow examinations to evaluate t...