Johnson & Johnson (NYSE:JNJ) submitted a supplemental New Drug Application for CAPLYTA®, aiming to prevent schizophrenia ...

Johnson & Johnson (NYSE:JNJ) is one of the most undervalued NYSE stocks to buy now. On July 8, Johnson & Johnson announced ...

Titusville: Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug ...

The supplemental New Drug Application is supported by Phase III data, which showed Caplyta significantly prolonged time to ...

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

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

CAPLYTA is already FDA-approved for treating schizophrenia and depressive episodes associated with bipolar I or II disorder, both as monotherapy and as adjunctive therapy with lithium or valproate.

Johnson & Johnson submits sNDA to US FDA for Caplyta for prevention of relapse in schizophrenia: Titusville, New Jersey Wednesday, July 9, 2025, 14:00 Hrs [IST] Johnson & Johnson ...

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 ...

On July 8, Johnson & Johnson announced the submission of a supplemental New Drug Application/sNDA to the US FDA for its schizophrenia drug called CAPLYTA (lumateperone).