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

In Actavis Labs. FL, Inc. v. U.S.  (“Actavis”), a recent precedential decision, the Federal Circuit answered an important ...

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.

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

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 ...

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 ...

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.

(RTTNews) - Milestone Pharmaceuticals (MIST) announced the FDA issued a Complete Response Letter regarding its New Drug Application for CARDAMYST nasal spray, a prescription medication in ...

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 ...

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 ...

Tonix Pharmaceuticals (NASDAQ:TNXP) was able to have its New Drug Application of TNX-102 SL ... It is also in the process of developing its anti-CD40L monoclonal antibody TNX-1500 for prevention ...