Articles related to FDA

The FDA has approved the first generic version of baloxavir marboxil, a single-dose influenza antiviral noninferior to oseltamivir, ahead of the 2026-2027 flu season.

The FDA approved olezarsen (Tryngolza), an apoC-III antisense inhibitor, as an adjunct to diet for reducing triglycerides and acute pancreatitis risk in adults with severe hypertriglyceridemia, based on phase 3 data showing an 85% reduction in pancreatitis events compared with placebo.

Breckenridge Pharmaceutical initiated a voluntary Class II recall of duloxetine delayed-release capsules 60 mg (Lot 241069C, expiration May 31, 2027) on April 21, 2026, following detection of elevated N-nitroso-duloxetine impurity levels attributed to CGMP deviations at the Barcelona manufacturing site, affecting 165,761 bottles distributed nationwide.

An EEG-guided neuromodulation system received FDA clearance for PTSD treatment based on a randomized controlled trial. The platform uses individualized brain activity data to guide therapy, though detailed efficacy results have not been disclosed.

The FDA cleared the Dexcom Stelo Glucose Biosensor System for over-the-counter use in children ages 2 and older who do not use insulin, expanding a device previously limited to adults and supporting caregiver-supervised home glucose monitoring.

The FDA granted Fast Track designation to elunetirom, an oral CNS thyroid hormone receptor agonist, for adjunctive treatment of bipolar depression, while the agent remains in a 30-participant open-label phase 2 trial with no human efficacy data yet available.