FDA News

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.

The FDA accepted EIT Pharma’s lonafarnib NDA for chronic hepatitis D, supported primarily by the phase 3 D-LIVR trial.

FDA grants volixibat Breakthrough Therapy and Orphan Drug status for PSC pruritus, but recommends an additional phase 3 trial before NDA.

Resilient Pharmaceuticals has resubmitted its MDMA-assisted therapy NDA for PTSD without a new phase 3 trial, MAPS reported.

Hematology in July 2026: FDA priority review for Agios' mitapivat in sickle cell disease, plus Orca-T's approval for GVHD-free survival.

The mRNA-based vaccine wins full approval for adults aged 50 to 64 years and accelerated approval for adults aged ≥ 65 years following unanimous VRBPAC backing.

FDA approval is based on phase 3 FirstLight and RadiantLight trials, the first therapy to directly restore orexin signaling in adults with NT1.

The FDA approved a 12-hour OTC combination of guaifenesin, dextromethorphan, and naproxen for cold and influenza symptom relief.

The FDA has granted Fast Track designation to PVX108, Aravax's investigational peptide immunotherapy for peanut allergy, ahead of phase 2 data expected later in 2026.

Nephrology in July 2026: FDA approvals for atacicept, iptacopan, and Furoscix in IgAN/CKD, plus new IgAN and CKD trial data.

New Drug Applications and key trial readouts punctuated July for endocrinology, with treatments for hypocalcemia, diabetes, and more.

CaRi-Heart measures coronary inflammation from routine CT angiography and generates a personalized 10-year cardiovascular mortality risk score.

The FDA has officially granted Fast Track designation to HTX-001 for the treatment of non-obstructive hypertrophic cardiomyopathy.

The first-in-class NDSRI showed significant symptom improvement as early as week 1 across 4 phase 3 trials but carries boxed warnings for suicidality and abuse potential.

FDA approves Freenome's SimpleScreen CRC blood test for colorectal cancer screening in average-risk adults aged ≥45 years.

The approval makes MannKind Corporation’s furosemide injection the first and only autoinjector delivering SC furosemide with IV-equivalent exposure.

Richard Lafayette, MD, discusses how atacicept's FDA approval advances BAFF/APRIL targeting in IgA nephropathy.

Ann Marie Navar, MD, PhD, highlights enlicitide’s FDA approval for hypercholesterolemia and its potential to fundamentally change therapy.

If approved, encaleret will be the first treatment specifically indicated for this underrepresented patient population.

FDA expands RYALTRIS® approval to children aged 6 to 11 with seasonal allergic rhinitis, based on phase 3 trial data.

FDA accepted Camurus’ resubmitted CAM2029 application for acromegaly, with a target action date of December 18, 2026.