The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML.

The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

The Pre-Investigational New Drug Application (IND) Consultation Program fosters early ... needed for the IRB and/or FDA to make a determination. Learn more on the FDA process Here is where differences ...

On Friday, U.S. Sen. Rand Paul, R-Bowling Green, was joined by three colleagues in reintroducing bipartisan legislation to ...

Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...

In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a ...

The FDA granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.

The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

Researchers at Indiana University and Wuhan University in China have unveiled a groundbreaking chemical process that could ... chemists can now explore new drug candidates for treating diseases ...

today announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic ...