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 ...

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

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

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 ...

Johnson & Johnson (NYSE:JNJ) is one of the most undervalued NYSE stocks to buy now. On July 8, Johnson & Johnson announced the submission of a supplemental New Drug Application/sNDA to the US FDA for ...