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 ...

NEW YORK, May 03, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central ...

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 ...

ITCI submits Supplemental New Drug Applications (sNDAs) for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults. If ...

The sNDA submission is based on positive results from Studies 501 and 502 demonstrating CAPLYTA’s robust antidepressant efficacy and favorable safety and tolerability profile CAPLYTA, ...

Please provide your email address to receive an email when new articles are posted on . The FDA has approved Caplyta for treating adults with depressive episodes linked to bipolar I or II disorder, ...

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 ...

Caplyta is a brand-name prescription medication containing the active ingredient lumateperone. Currently, no generic version of the medication is available. An important note about Caplyta for older ...

CAPLYTA ®, in combination with an oral antidepressant, demonstrated superior efficacy with a favorable safety and tolerability profile consistent with established indications 1,2 In pivotal trials, ...

NEW YORK, May 03, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central ...