Articles related to DEVICE/DRUG APPROVALS

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.

The FDA approved a low-estrogen weekly contraceptive patch for pregnancy prevention in eligible women with BMI below 30 kg/m². Approval was supported by Phase 3 efficacy, safety, and adhesion data, but use remains subject to established combined hormonal contraceptive contraindications.

The FDA approved Furoscix ReadyFlow, a subcutaneous furosemide autoinjector for edema associated with heart failure or chronic kidney disease. Clinical data demonstrated pharmacokinetic exposure and diuretic effects comparable to intravenous furosemide.

The FDA approved Lytenava as the first ophthalmic bevacizumab formulation for wet AMD. The decision moves bevacizumab beyond repackaged intravenous use, with launch logistics still pending.