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.
Federal Register notice: FDA determines that 50 listed drug products were not withdrawn for safety or effectiveness reasons.
The 2nd Circuit Court of Appeals says a New York federal court properly granted summary judgment to FDA and Sarepta in a Freedom of Information Act ca...
FDA says the Haimen Shengbang Laboratory Equipment recall of unapproved viral transport media containers is Class 1.
