Instead, Galiatsatos said, the FDA approved the drug based on other signs of effectiveness, including whether patients were able to walk farther in six minutes than they could before they started ...
With the FDA nod, Alecensa becomes the second molecularly targeted therapy to move into the adjuvant setting for non-small cell lung cancer.
In the biotech and pharmaceutical world, FDA approval is the number one needle mover for drug stocks. Why? Because FDA ...
The health regulor has required related updates to other sections of the label such as warnings and precautions, ...
The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
The approval makes ravulizumab the first and only long-acting C5 complement inhibitor for this indication and is supported by data from the phase 3 CHAMPION-NMOSD trial (NCT04201262), published in ...
When a soldier is rushed to medical care following a blast or other injury to the head, time is crucial in deciding just how extensive that injury is. Now, the U.S. Army has announced that the U.S ...
Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of ...
Instead, Galiatsatos said, the FDA approved the drug based on other signs of effectiveness, including whether patients were able to walk farther in six minutes than they could before they started ...