An FDA safety alert warns that patients who stop taking oral allergy medicines cetirizine or levocetirizine after long-term use may experience rare bu...
FDA clears a Stryker 510(k) for its OptaBlate basivertebral nerve ablation system and its use for procedures providing vertebrogenic pain relief.
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 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.
