FDA News

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.

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.

The NDA submission follows positive results from the CALIBRATE phase 3 trial, which evaluated encaleret versus standard-of-care in adults with ADH1.

Mitapivat has been submitted to the FDA for accelerated approval in sickle cell disease after phase 3 results showed a hemoglobin benefit.

This FDA News Month in Review provides a round-up of regulatory decisions from April 2026.

Catch up on 5 nephrology headlines you missed in April 2026, including WCN coverage, FDA updates, and trial data.

The FDA has approved budesonide/glycopyrrolate/formoterol fumarate as the first single-inhaler triple therapy for asthma.

AbbVie submitted an sNDA to the FDA seeking approval of upadacitinib for severe alopecia areata in adults and adolescents.

The FDA granted Fast Track Designation to coramitug, an investigational anti-TTR antibody designed to clear existing amyloid deposits in ATTR cardiomyopathy.

The FDA has accepted bepirovirsen's NDA for Priority Review and granted Breakthrough Therapy designation, with a PDUFA date of October 26, 2026.

FDA cleared Control-IQ+ for pregnancy in type 1 diabetes, expanding automated insulin delivery options during gestation.

This supplemental New Drug Application for roflumilast cream (Zoryve) to the FDA was supported by the INTEGUMENT-INFANT open-label study.

The FDA approved anifrolumab via a once-weekly subcutaneous autoinjector for moderate to severe SLE based on phase 3 TULIP-SC trial results.

The FDA approved a lumateperone sNDA adding relapse prevention data in schizophrenia based on a 63% reduction in relapse risk versus placebo.

AbbVie submitted an FDA application for risankizumab subcutaneous induction in Crohn's disease based on phase 3 AFFIRM data.