FDA extends by two months its review of a PharmaTher NDA for Ketarx (ketamine) that is seeking anesthesia, sedation, pain, mental health, neurological...
FDA commissioner Marty Makary agrees to testify 5/22 at a Senate appropriations subcommittee hearing on the agencys fiscal year 2026 budget request.
FDA commissioner Marty Makary announces a 5/20 roundtable discussion on the safety and necessity of talc as an additive in food, drug, and cosmetic pr...
FDA lifts a clinical hold against Scynexiss ibrexafungerp that will allow it to proceed with its Phase 3 MARIO study in invasive candidiasis and candi...
FDA accepts for review a Travere Therapeutics supplemental NDA for traditional approval of Filspari (sparsentan) for treating focal segmental glomerul...
FDA clears a Fujirebio Diagnostics 510(k) for the first in vitro diagnostic device that tests blood in diagnosing Alzheimers disease.
FDA posts briefing documents outlining issues to be discussed during a two-day (5/20-21) Oncologic Drugs Advisory Committee meeting that is reviewing ...
FDA says it is delaying for three months the PDUFA action date for Biohavens troriluzole to treat spinocerebellar ataxia.
