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

Ziftomenib’s FDA application for relapsed/refractory NPM1-mutant acute myeloid leukemia is supported by data from the ...

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.

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 ...

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 ...

Drug repurposing, or finding new uses for existing medications, could potentially lower the cost of prescription drugs and medical expenses and accelerate the discovery of new treatments. In the ...

Click Here to Manage Email Alerts Back to Healio We were unable to process your request ... Aldeyra plans to resubmit the new drug application with new trial data later this year.