Mark T. Gladwin, MD, Dean of the University of Maryland School of Medicine announced today that Deanna L. Kelly, ...

Digital technology may be on the verge of ‘breaking out’ for schizophrenia treatment, but numerous questions will need to be ...

Amarna Therapeutics and NorthX Biologics finalized an agreement to advance Nimvec AM510 gene therapy toward clinical trials for Type 1 Diabetes. Now in its fourth year, the MM+M Media Summit brings ...

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 ...

Johnson & Johnson (JNJ) said on Tuesday that it has submitted a supplemental new drug application 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 ...

After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in ...

For 35 years, the FDA has placed onerous restrictions on the only drug it has ever approved for treatment-resistant schizophrenia, and the only one it recognizes as reducing the risk of suicide. This ...

Patients with schizophrenia will no longer have to provide blood test results before filling their clozapine prescription, according to the US Food and Drug Administration (FDA).

The U.S. Food and Drug Administration has removed one hurdle faced by patients with schizophrenia when filling prescriptions for the antipsychotic medication clozapine.

The Food and Drug Administration has taken a crucial step toward expanding access to the antipsychotic medication clozapine, the only drug approved for treatment-resistant schizophrenia, among the ...

The FDA has eliminated a longstanding requirement that patients taking clozapine, an antipsychotic used for treatment-resistant schizophrenia, to submit blood test results before their ...