Articles related to DEVICE/DRUG APPROVALS

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.

The FDA granted 510(k) clearance for a wireless-enabled pressure-modulating goggle system designed to reduce nocturnal intraocular pressure in adults with open-angle glaucoma, with availability expected in Q4 2026.

The FDA accepted asundexian’s secondary-stroke-prevention application for Priority Review, supported by phase 3 OCEANIC-STROKE results in noncardioembolic ischemic stroke.

Ipsen voluntarily withdrew tazemetostat in follicular lymphoma and epithelioid sarcoma after 18 of 318 SYMPHONY-1 participants developed hematologic second primary malignancies, including three deaths.

Adding niraparib to abiraterone prolonged radiographic progression-free survival in BRCA-mutant metastatic hormone-sensitive prostate cancer, with overall survival data still maturing.