FDA News

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.

The FDA granted traditional approval to Novartis’ iptacopan (Fabhalta) for adults with primary IgA nephropathy, supported by phase 3 APPLAUSE-IgAN data showing slowed kidney function decline and sustained proteinuria reductions.

FDA approved once-daily oral enlicitide to lower LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

FDA grants priority review to obinutuzumab, positioning it as the first potential approved therapy for primary membranous nephropathy.

Catch up on some of the biggest FDA news, clinical trial updates, and featured HCPLive coverage from the first half of 2026.

The supplemental New Drug Application for Arcutis’ roflumilast cream 0.05% (Zoryve) is for mild to moderate atopic dermatitis in those down to 3 months.

Review the biggest gastroenterology news from the first half of 2026, including FDA updates, IBD advances, and key clinical trials.

The FDA granted accelerated approval to atacicept to reduce proteinuria in adults with primary IgAN at risk for disease progression

FDA grants Priority Review to Agios’ mitapivat sNDA for sickle cell disease, with a PDUFA date set for November 1, 2026.

Here are 7 of the biggest nephrology stories from Q2 of 2026!

Phase 3 RAPIDe-3 data show rapid, sustained relief of hereditary angioedema attacks; PDUFA date set for April 23, 2027.