FDA deputy commissioner for policy, legislation, and international affairs Grace Graham highlights major changes coming to FDA under the Trump Adminis...
Ionis Pharmaceuticals reports positive topline results from the Essence study of olezarsen in people with moderate hypertriglyceridemia.
FDA approves a Novavax BLA for traditional approval of Nuvaxovid for active immunization to prevent Covid-19 that includes a more limited intended pat...
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 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...
