EBGLYSS received FDA approval based on results from two key clinical trials, ADvocate 1 and ADvocate 2, as well as the ADhere study. These trials evaluated the drug’s effectiveness in patients ...

The U.S. Food and Drug Administration (FDA) gave it the green light on July 2, 2024, despite initially denying approval just a year earlier. This reversal has raised eyebrows in the medical community ...

Sept. 26 (UPI) --The U.S. Food and Drug Administration has approved a new drug for adults with schizophrenia, the FDA announced Thursday. The drug, generically called Cobenfy, is the first oral ...

27, 2024 – In a breakthrough for people living with schizophrenia, the FDA has approved a new oral medication ... Psychiatry at the FDA’s Center for Drug Evaluation and Research.

FDA approves Pfizer’s Hympavzi for routine prophylaxis in hemophilia A and B patients, offering a once-weekly dosing via auto-injector pen. Phase 3 trial showed Hympavzi reduced bleeding rates ...

The US Food and Drug Administration (FDA) has approved ustekinumab-srlf (Imuldosa) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the fifth ...

The U.S. Food and Drug Administration has granted approval to the first new schizophrenia drug type in decades. The new drug, Cobenfy, is marketed by pharmaceutical giant Bristol Myers Squibb.

The medication, Cobenfy, combines two drugs and is taken as a twice-daily pill. The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with ...

No new treatments for schizophrenia have been approved in nearly three decades, but that changed on Sept. 26, when the U.S. Food and Drug Administration (FDA ... in-class, best-in-category ...

The first new type of medication in decades to help fight against schizophrenia was approved on Thursday ... Office of Neuroscience in the FDA's Center for Drug Evaluation and Research.

Tiffany Farchione, director of psychiatry in the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This drug takes the first new approach to schizophrenia treatment in ...

11 (UPI) --Patients suffering from hemophilia received a "meaningful" advancement on Friday when federal regulators approved the ... Ann Farrell of the FDA's Center for Drug Evaluation and Research.