FDA News

The US FDA has approved olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.

FDA cited manufacturing and labeling issues in its CRL for cytisinicline, with no clinical efficacy or safety deficiencies reported.

The FDA has cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children as young as 2 years who do not use insulin.

Teplizumab becomes the first disease-modifying therapy approved for patients recently diagnosed with stage 3 type 1 diabetes.

Eli Lilly announced FDA approval of a 250 mg every-8-week lebrikizumab maintenance regimen, supported by 32-week ADjoin extension data.

The FDA marked bemotrizinol as first new active ingredient on the over-the-counter (OTC) sunscreen monograph since the 1990s.

Khlevner, MD, discusses the expanded FDA approval of linaclotide for children aged ≥2 years with functional constipation.

Catch up on major trial results, key FDA decisions, and more.

Catch up on the key nephrology news, research findings, and expert insights featured on HCPLive throughout May 2026.

May 2026 saw substantial FDA decisions, major trial results, guideline updates, and more.

The FDA declined to approve Cingulate's once-daily ADHD therapy CTx-1301, citing CMC information requests with no clinical safety or efficacy concerns identified.

FDA accepted a priority review sNDA for mavacamten in adolescents with symptomatic obstructive hypertrophic cardiomyopathy.

FDA accepts the BLA for povetacicept in IgA nephropathy, supported by positive phase 3 RAINIER trial data.

The FDA has approved fast-acting inhaled insulin Afrezza for pediatric patients aged 6-18 years with T1D or T2D.

This episode covers the FDA’s recent approval of MannKind’s inhaled insulin Afrezza for patients aged 6-18 years with either T1D or T2D.

Saroglitazar received FDA Priority Review for adults with PBC after phase 3 data showed improved biochemical response versus placebo.

The approval indicates linaclotide for pediatric patients ≥ 2 years of age with functional constipation, expanding its previous use in patients ≥ 6 years of age.

FDA De Novo classification clears Cardiosense PCWP Analysis Software to estimate filling pressures in selected adults with HFrEF.

Until this decision, clinicians relied on off-label, interferon-based regimens with limited efficacy.

The FDA accepted Bayer’s sNDA for finerenone in adults with type 1 diabetes and CKD based on albuminuria data from FINE-ONE.

FDA granted priority review to asundexian for secondary prevention after non-cardioembolic ischemic stroke or TIA.

FDA approved baxdrostat as add-on therapy for adults with hypertension not controlled on other medications.

The FDA has cleared the EndoTool IV Cloud for hospital IV insulin dosing support, expanding Glooko’s inpatient platform via the 510(k) pathway.

The FDA approved Abbreviated New Drug Applications from Lupin Pharmaceuticals for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials.

After roughly 14 months leading the agency and recent reports of the Trump administration planning his removal, FDA Commissioner Marty Makary, MD, MPH, has resigned.