FDA News

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.

FDA clears setmelanotide for acquired hypothalamic obesity for ages 4 years and older, delivering 15.8% BMI drop in TRANSCEND.

The IBAT inhibitor’s approval, the first for this indication, was based on data from the GLISTEN trial showing reductions in cholestatic pruritus and itch-related sleep interference.

The approval is based on results from the STEP UP trial program showing substantial weight loss in adults with obesity.

The MiniMed Flex is a discreet, smartphone-controlled insulin pump that is roughly the size of 2 stacked insulin vials.

FDA clears once-daily icotrokinra for moderate-to-severe plaque psoriasis in adults and teens.

The FDA has issued its third CRL to topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease.

Investigational RNA interference therapy targeting prekallikrein enters accelerated regulatory pathway as phase 2 trial evaluates long-acting prophylaxis for HAE.

The FDA has set a PDUFA date of December 30, 2026.

This FDA approval of secukinumab (Cosentyx) for hidradenitis suppurativa (HS) represents the fourth pediatric indication for the drug.

The approval comes after the FDA requested GSK submit an sNDA for leucovorin for the treatment of CFD-FOLR1.

The FDA accepted Mineralys Therapeutics’ NDA for lorundrostat in hypertension, but the selective aldosterone synthase inhibitor fell short in a phase 2 obstructive sleep apnea trial.