A new law that took effect on Jan. 1 regulates some practices of PBMs, which act as middlemen between drug manufacturers, ...

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 ...

A Prescription Drug User Fee Act target date of July 24, 2025 has been set for the sNDA application. The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA ...

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 ...

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 ...

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 ...

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 set a Prescription Drug User Fee Act (PDUFA) target action date and determine if Priority Review will be granted in the upcoming Day 74 Letter. TNX-102 SL, a sublingual ...

If granted, the resulting six-month FDA review period is expected to result in a potential Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025. Dordaviprone has ...

Robert F. Kennedy Jr., Donald Trump’s pick to lead the US Department of Health and Human Services, has been vocally ...

The Prescription Drug User Fee Act date is 7 May 2025. Price Action: GSK stock closed at $33.95 on Thursday.