GlobalData on MSN15h
FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
WBRC FOX6 News2d
FDA bans certain synthetic dye from cosmetics but allows in food, advocate calls it ‘illogical’
FDA denied a petition to authorize use of Red No. 3 in cosmetics and topical drugs due to the existence of data demonstrating ...
FDA vaccines chief hopes for common ground with RFK Jr.
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 ...
Targeted Oncology11h
FDA Approves Revumenib in KMT2A-Rearranged Acute Leukemia
Revumenib is now an FDA-approved treatment for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute ...
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Other voices: AI will transform medicine. But it needs more data first
A key challenge for AI-reliant medical devices is the amount of data needed to train their models. In the U.S., such ...
What is oral phynylephrine and why does the FDA want to remove it from cold medicine?
Oral phenylephrine is used in over-the-counter products like Sudafed and Dayquil to help temporarily relieve the common ...
After decades, FDA finally moves to pull ineffective decongestant off shelves
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...
FierceBiotech2d
FDA hits Kezar's zetomipzomib program with 2nd clinical hold in 2 months
The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...