Articles related to DEVICE/DRUG APPROVALS

The FDA approved RayOne Galaxy and RayOne Galaxy Toric for US commercial availability following a multicenter IDE study of more than 250 patients, expanding presbyopia-correcting IOL options for cataract surgeons.

The FDA has approved once-monthly subcutaneous olanzapine for adults with schizophrenia, supported by placebo-controlled trial data showing symptom improvement and sustained efficacy through 48 weeks, while eliminating several logistical requirements associated with treatment initiation.

The FDA has approved tavapadon, a selective D1/D5 dopamine receptor partial agonist, for adults with Parkinson disease following phase 3 studies demonstrating benefit both as monotherapy in early disease and as adjunctive therapy to levodopa.

The FDA approved tirzepatide to reduce major cardiovascular event risk in high-risk adults with type 2 diabetes. SURPASS-CVOT established noninferiority to dulaglutide rather than cardiovascular superiority.

The FDA approved Moderna’s mFLUSIVA, the first mRNA influenza vaccine, for adults aged 50 and older. Availability is expected during the 2026–2027 respiratory virus season, with confirmatory evidence pending for adults 65 and older.

The FDA expanded the indication for olopatadine hydrochloride and mometasone furoate nasal spray to include children aged 6 to younger than 12 years with seasonal allergic rhinitis. Approval was supported by a phase 3 trial demonstrating improved nasal symptoms versus placebo.