Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more ...

Understanding the Drug Development Process Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments.

Novel drugs typically go through the New Drug Application (NDA) or Biologics License Application (BLA) process, which involves clinical trials to show they’re safe and effective.

A New Drug Application (NDA) has been submitted to the Food and Drug Administration for ziftomenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a ...

The FDA has accepted Stealth BioTherapeutics’ third new drug application for its ultra rare disease candidate, providing a ...

The department's plan includes using artificial intelligence to examine device and drug applications, which would reportedly shave years off of the approval process, as well as AI computational ...

Similar to seeking FDA approval for initial uses for new drugs, manufacturers must submit applications for approval for these new uses – this application process may involve a supplement to the ...

AbbVie is seeking a new way to fight chronic lymphocytic leukemia by combining its oncology drug Venclexta with another cancer-fighting drug.