In fact, with the Prescription Drug User Fee Act due to be renewed in 2027, the new administration could immediately begin planning for a transition to an FDA budget free of funding conflicts of ...

assigned a Prescription Drug User Fee Act, PDUFA, goal date of August 15, 2025, for a decision on marketing approval, MA, for TNX-102 SL for fibromyalgia. TNX-102 SL is a non-opioid, centrally ...

FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter TNX-102 SL is a non-opioid ...

Matter of fact, a Prescription Drug User Fee Act [PDUFA] date of June 17th, 2025 was the established date to review this specific drug for the treatment of these patients. Not only that ...

The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it ...

has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2025 to the Company’s recently submitted supplemental Biologics License Application for the F8 formulation of ...

Here’s what you need to know. What To Know: The FDA’s acceptance of the NDA triggers a process in which the agency will assign a Prescription Drug User Fee Act (PDUFA) target action date and ...

A Prescription Drug User Fee Act target date of July 27, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License ...

The FDA is expected to assign the NDA a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter. At that time, the FDA will also communicate to Tonix whether Priority Review ...