FDA News

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.

The FDA set a June 18, 2027, PDUFA date for the subcutaneous GP IIb/IIIa inhibitor, based on phase 3 CeleBrate data.

DBV has requested priority review for the epicutaneous patch, supported by phase 3 VITESSE data showing a 31.8-point responder rate gain vs placebo.

FDA approved mavacamten for oHCM in children weighing 30 kg or more after SCOUT-HCM showed a 48.0-mm Hg Valsalva LVOT gradient reduction vs placebo.

Donald Cutlip, MD, discusses the sirolimus balloon’s approval and its role in clinical practice for patients with ISR.

Approval is based on 36-week data from BRAVE-AA-PEDS, in which 42% of patients on the 4 mg dose achieved a SALT score of 20 or less, compared with 5% on placebo.

The FDA approved once-daily oral zilurgisertib for FOP in patients aged 12 years and older after the phase 2 PROGRESS trial showed reduced new heterotopic ossification vs placebo.

FDA clears Eli Lilly’s Onswik weekly insulin from QWINT trials, cutting injections for type 2 diabetes while matching daily basal control.

The FDA-approved update adds phase 3 HYPERION data on adults diagnosed with PAH within the past year.

The FDA has granted Priority Review to dersimelagon for EPP and XLP, setting a PDUFA date for late February 2027 as LEO Pharma completes its acquisition from Tanabe Pharma.

The approval, backed by FINE-ONE data showing a 28% UACR reduction at 6 months, is the first new CKD treatment for this group in 3 decades.

FDA accepts Cogent's bezuclastinib NDA for advanced systemic mastocytosis, backed by APEX trial data showing durable, high-rate responses.

Ameluz is now the first FDA-approved photodynamic therapy for a skin cancer, expanding use to superficial basal cell carcinoma (sBCC) in adults.

Phase 3 data show zasocitinib use led to clear or almost clear skin in around 70% of patients by Week 16, setting up an FDA decision in early 2027.

Beta Bionics plans to launch Mint through the pharmacy channel in the first quarter of 2027.

The FDA granted DT120 (lysergide) ODT Breakthrough Therapy designation for MDD, citing promising phase 3 Emerge data.

The FDA granted lonvo-z priority review for HAE, setting a PDUFA date of March 10, 2027 based on positive Phase 3 HAELO data.

Abbott's dual-energy PFA/RF ablation catheter met its primary effectiveness and safety endpoints in the 12-month FlexPulse IDE study behind its FDA nod.

SURPASS-CVOT showed tirzepatide is non-inferior to dulaglutide for cardiovascular events in more than 13,000 adults with type 2 diabetes.

The approval adds brepocitinib (Lisraya), an oral JAK/TYK2 inhibitor, as the first agent specifically studied and approved for dermatomyositis in adults.

Daraxonrasib (Rasonque) extended median survival to 13.2 months versus 6.7 months with chemotherapy in a phase 3 trial.

Nipocalimab-aahu (IMAAVY) is now approved for wAIHA, based on Phase 2/3 ENERGY trial data showing durable hemoglobin response.

United Therapeutics' ralinepag NDA rests on phase 3 ADVANCE OUTCOMES data showing a 55% reduction in clinical worsening versus placebo.

The generic nasal spray is bioequivalent to Haleon's Flonase, indicated for nasal symptoms of allergic rhinitis.

The first-in-class D1 receptor antagonist earns Priority Review and Orphan Drug designation, with an FDA action date late in Q1 2027.