Articles related to DEVICE/DRUG APPROVALS

The FDA approved cefepime-zidebactam (Zaynich) for complicated UTI and pyelonephritis caused by susceptible gram-negative organisms. Approval followed phase 3 trial data showing higher rates of symptom and microbiologic resolution compared with meropenem in hospitalized adults.

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.

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 has approved an OTC switch for adapalene/benzoyl peroxide gel (Differin Epiduo) for patients 12 and older, expanding adolescent access to a fixed-dose retinoid combination without a prescription or clinical visit.

The FDA approved inhaled insulin (Afrezza) for pediatric patients aged 6 and older with type 1 or type 2 diabetes, based on phase 3 trial data and long-term safety evidence from manufacturer-sponsored studies.

The FDA approved baxdrostat (Baxfendy), a selective oral aldosterone synthase inhibitor, as an adjunctive treatment for adults with hypertension uncontrolled on at least two existing antihypertensive agents, including a diuretic.