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.
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 says it is delaying for three months the PDUFA action date for Biohavens troriluzole to treat spinocerebellar ataxia.
IQVIA senior director David Cameron says FDA oncology initiatives like Project FrontRunner can help speed innovative cancer treatments to patients.
