6 FDA Headlines You Missed in April 2026

Welcome back to our recap of this month’s news and updates from the US Food and Drug Administration (FDA)!

April 2026 was a busy month for the FDA, with several major new approvals and expanded indications taking center stage. Everything from diabetes to lupus and schizophrenia received a major regulatory update.

Among these approvals, Eli Lilly’s orforglipron became the first GLP-1 without food or water restrictions to receive approval for weight loss, while Apotex Corp’s generic semaglutide injection was tentatively accepted by the FDA. Sparsentan also became the first-ever approved FSGS medication, breaking new ground in an otherwise underserved disease state.

Given the number of regulatory actions taken by the FDA last month, the editorial team at HCPLive has collected 6 of the most impactful headlines from April 2026 – catch up on anything you might have missed below.

1: FDA Approves Orforglipron (Foundayo) As First Daily GLP-1 Pill Without Food, Water Restrictions

Announced on April 1, 2026, by parent company Eli Lilly, the FDA officially approved orforglipron, a once-daily small molecule non-peptide oral GLP-1 receptor agonist, for adults with obesity or overweight and weight-related medical problems. This approval marks the first GLP-1 to have no associated food or water restrictions – it can be taken at any time.

2: FDA Gives Tentative Approval of ANDA for Generic Semaglutide Injection

On April 10, 2026, the FDA announced its tentative approval of an Abbreviated New Drug Application (ANDA) for a generic form of injectable semaglutide. Submitted by Apotex Corp, this application and its approval mark a substantial regulatory step towards potential generic competition in the GLP-1 class. Notably, however, the approval does not allow immediate marketing – instead, it indicates that the application meets FDA standards for safety and efficacy.

3: FDA Approves Sparsentan for Focal Segmental Glomerulosclerosis

On April 13, 2026, Travere Therapeutics announced the FDA’s approval of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS). This approval marks the first-ever therapy for FSGS – sparsentan is the only non-immunosuppressive oral medication that directly targets podocyte injury by blocking endothelin A receptors and angiotensin II subtype 1 receptors.

4: FDA Expands Dupilumab to Children Aged 2 to 11 Years With Uncontrolled CSU

The FDA approved dupilumab’s expanded indication for children aged 2-11 years with chronic spontaneous urticaria (CSU) that remains symptomatic despite H1 antihistamine treatment on April 22, 2026. Announced by both Regeneron and Sanofi, this approval extended the prior indication in adults and adolescents aged 12 years and older.

5: Lumateperone sNDA Approved with Relapse Prevention Data in Schizophrenia

Johnson & Johnson announced the FDA’s approval of a supplemental NDA for lumateperone to prevent relapse in adults with schizophrenia on April 26, 2026. The decision came after a phase 3 randomized withdrawal trial demonstrated a 63% reduction in relapse risk compared to placebo over a 26-week double-blind treatment period.

6: Anifrolumab (Saphnelo) Wins FDA Approval for Subcutaneous Self-Administration in SLE

On April 27, 2026, the FDA announced its approval of anifrolumab-fnia for subcutaneous self-administration via a once-weekly 120 mg autoinjector, the Saphnelo Pen, in adults with moderate to severe systemic lupus erythematosus who are already receiving standard therapy. The decision was based on parent company AstraZeneca’s phase 3 TULIP-SC trial, which saw 29% of patients receiving treatment achieve DORIS remission and 40.1% attain low-level disease activity.