FDA News

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.

FDA approved lunsotogene parvec for OTOF-related hearing loss based on phase 1/2 data showing improved hearing in a small cohort.

FDA approved dupilumab for children aged 2 to 11 years with chronic spontaneous urticaria uncontrolled by H1 antihistamines.

Teplizumab is now approved to treat stage 2 type 1 diabetes in kids 1 year and older.

If approved, the novel corticosteroid therapy would be the first and only FDA-approved hydrocortisone acetate suppository.

The FDA accepted Genentech's sBLA for obinutuzumab in SLE based on positive phase 3 ALLEGORY trial results, with a decision expected by December 2026.

This episode explores the launch and accessibility of FDA-approved oral GLP-1 orforglipron, including availability through Amazon Pharmacy's same-day delivery service.

The FDA has accepted LEO Pharma's sNDA for delgocitinib cream for moderate-to-severe chronic hand eczema in adolescents.

A DUPLEX study investigator explains the data behind sparsentan's approval by the FDA.

FDA fully approves sparsentan for FSGS, offering the first oral non-immunosuppressive option that targets podocyte injury and cuts proteinuria.

Although the approval does not permit entrance into the market, this decision marks an important step to more universally accessible GLP-1 RAs.

Catch up on nephrology headlines you missed from Q1 2026.

A look at 13 key FDA approvals from Q1 2026, highlighting advances in rare disease, pediatrics, novel therapies, and patient-centered innovation.

The Agency approved Lilly’s orforglipron (Foundayo) for adults with obesity or overweight. It can be taken any time of the day without restrictions on food and water intake.

FDA approvals broaden ALYFTREK and TRIKAFTA eligibility to nearly 95% of US cystic fibrosis patients using a functional, mechanism-based variant criterion.

The indication makes insulin icodec the first new class of basal insulin to reach US patients in more than 2 decades.

This episode features discussion around 3 recent announcements from Novo Nordisk, Eli Lilly, and Structure Therapeutics.