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 ...
Nasdaq

ITCI Submits sNDA to the FDA for Expanded Use of Caplyta in MDD

Intra-Cellular Therapies ITCI announced that it has submitted a supplemental new drug application (sNDA) to the FDA aiming to expand the approved uses of its lead drug, Caplyta (lumateperone), to ...
Nasdaq

Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy

BEDMINSTER, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for ...
NJBIZ

FDA approves J&J’s Caplyta as add-on depression drug

The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson‘s Caplyta as an add-on treatment for adults with major depressive disorder. Following the FDA’s Nov. 5 decision ...
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 ...
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 ...
WOOD-TV

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo CAPLYTA ® is FDA approved to treat schizophrenia ...
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 ...
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 ...