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

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

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application to the U.S. Food and Drug ...

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 ...

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 ...

Caplyta may cause problems with body temperature, making it difficult for your body to cool down (heat intolerance).Heavy exercise, extreme heat, dehydration, and certain medicines may worsen heat ...

Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to ...

Caplyta (lumateperone) is a brand-name oral capsule that’s prescribed for schizophrenia and bipolar depression in adults. If you have problems with side effects from Caplyta, talk with your ...

Pooled analysis of 3 randomized, double-blind, pacebo-cotrolled trials supports the safety and the distinct and favorable tolerability profile of lumateperone 42 mg Mean change from baseline in ...

Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to ...