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 ...
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.
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 ...
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 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 ...
“This drug takes the first new approach to schizophrenia treatment in decades,” Tiffany Farchione, director of FDA’s division of psychiatry, said in a statement. “This approval offers a ...
It’s called Cobenfy, and it’s the first new drug for the mental health condition to be successfully developed in over 70 years. Cobenfy, now FDA-approved, is unique because it targets the ...
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 U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in ...
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) approved Cobenfy for the psychiatric ...
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 ...
The approval of Retevmo is for the treatment of adults and children aged 2 years and older with advanced or metastatic medullary thyroid cancer. The Food and Drug Administration (FDA) approved Retevmo ...