The approval expands the indication of lumateperone, an oral atypical antipsychotic, to include relapse prevention based on long-term clinical data. The therapy is administered once daily at a dose of 42 mg and does not require titration. The FDA's approval was supported by Study 304, a phase 3, multicenter, double-blind, placebo-controlled, randomized withdrawal trial evaluating lumateperone in adults with schizophrenia.
April 27: Caplyta (lumateperone)
On April 27, 2026, the FDA approved a supplemental New Drug Application for Caplyta (lumateperone) for the prevention of relapse in adults with schizophrenia.
April 21: Idvynso (doravirine/islatravir)
On April 21, 2026, the FDA approved doravirine 100 mg/islatravir 0.25 mg (Idvynso), a once-daily, fixed-dose, 2-drug oral regimen, for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen.
The indication applies to patients with no history of virologic treatment failure and no known substitutions associated with doravirine resistance. Idvynso is a complete regimen and should not be coadministered with other antiretroviral medications for HIV-1 treatment. The approval was supported by Week 48 data from 2 of the Phase 3 randomized, active-controlled, noninferiority trials (Trial 052 [NCT05630755] and Trial 051 [NCT05631093]) in virologically suppressed adults.
April 2: Tecartus (brexucabtagene autoleucel)
On April 2, 2026, the FDA granted traditional (full) approval to Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The indication includes patients who have received 1 or more prior lines of therapy, including those who are Bruton tyrosine kinase inhibitor (BTKi)–naïve. This action converts the prior accelerated approval to full approval based on confirmatory evidence. Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell immunotherapy. The approval is supported by data from ZUMA-2, a single-arm, open-label, multicenter study evaluating brexucabtagene autoleucel in adults with relapsed or refractory MCL.
April 1: Foundayo (orforglipron)
On April 1, 2026, the FDA approved Foundayo (orforglipron), a once-daily, small-molecule, nonpeptide oral glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management in adults with obesity or those who are overweight with at least 1 weight-related medical condition.
The drug is indicated for use alongside a reduced-calorie diet and increased physical activity. Orforglipron can be taken at any time of day, regardless of food or water intake. It is not known whether orforglipron is safe and effective in children. The approval was supported by the phase 3 ATTAIN clinical trial program, including ATTAIN-1, a 72-week, randomized, double-blind, placebo-controlled trial in adults with obesity or overweight without diabetes.