Morningstar

FDA approves CAPLYTA® (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia

TITUSVILLE, N.J., April 27, 2026 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on ...
Medical Xpress

FDA approves Caplyta for major depressive disorder in adults

The U.S. Food and Drug Administration has approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder in adults. This approval marks ...
FiercePharma

Another Caplyta trial win moves Intra-Cellular closer to FDA filing in major depressive disorder

Intra-Cellular Therapies has unveiled another positive late-stage trial readout for Caplyta, taking another step toward a potential blockbuster label expansion for the depression drug. In what CEO ...
Morningstar

CAPLYTA® (lumateperone) showed greatest improvement across key efficacy outcomes among adjunctive MDD treatments in new network meta-analysis

CAPLYTA® ranked highest among FDA-approved adjunctive therapies across four measures of efficacy, based on indirect comparisons from placebo plus antidepressant therapy-controlled trials Among the ...
NJBIZ

FDA approves J&J’s Caplyta to prevent schizophrenia relapse

The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson’s Caplyta to help stop relapse in patients with schizophrenia. Regulators signed off April 24 on the New ...
FiercePharma

Intra-Cellular nabs nod for schizophrenia drug Caplyta after FDA twists and turns

Intra-Cellular Therapies had quite a journey toward an FDA decision on its antipsychotic contender. It involved mixed clinical data, a canceled advisory committee meeting and a three-month review ...
Healio

FDA approves Caplyta for relapse prevention in schizophrenia

Please provide your email address to receive an email when new articles are posted on . Risk for relapse fell by 63% with Caplyta compared with placebo. There were no relapses over 6 months for 84% of ...
abc27

FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder

TITUSVILLE, N.J., Nov. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved CAPLYTA ® (lumateperone) as an adjunctive therapy ...
Medscape

FDA Grants New Indication to Lumateperone (Caplyta) for Bipolar Depression

The US Food and Drug Administration (FDA) has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as ...
Healio

FDA approves Caplyta as adjunctive therapy in adults with major depressive disorder

Please provide your email address to receive an email when new articles are posted on . Caplyta had been previously approved by FDA for bipolar I and II depression and schizophrenia. Approval was ...