FDA sends CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure p...
FDA warns West Sacramento, CA-based Valley Biosystems about violations in its conduct of two nonclinical laboratory studies.
FDA warns Natick, MA-based Infutronix about Quality System and Medical Device Reporting violations in its production of infusion pumps and administrat...
FDA issues Bavarian Nordic an emergency use authorization for its smallpox/monkeypox vaccine Jynneos to allow healthcare providers to use administer i...
CDER advertising researchers say their study of character-space-limited communications like Tweets in terms of drug benefit and risk information has i...
FDA warns Amazon.com that its fulfillment service is distributing unapproved new drugs sold over-the-counter as mole and skin tag removers.
FDA extends by three months the review of a Reata Pharmaceuticals NDA for omaveloxolone to allow time to evaluate additional data just submitted to th...
Federal Register notice: FDA renews its Allergenic Products Advisory Committee for an additional two years beyond the charter expiration date.
