The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
The FDA's Dr. Peter Marks says he hopes to keep his job under a second Trump term, and urges Robert F. Kennedy Jr. to "keep ...
FDA denied a petition to authorize use of Red No. 3 in cosmetics and topical drugs due to the existence of data demonstrating ...
Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute ...
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
A key challenge for AI-reliant medical devices is the amount of data needed to train their models. In the U.S., such ...
Oral phenylephrine is used in over-the-counter products like Sudafed and Dayquil to help temporarily relieve the common ...
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...
The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...