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.

FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with ...

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

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.

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

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.