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 ...

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 ...

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 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 ...

Novo Nordisk expects Ozempic, which has been on the market since 2017, will be on Medicare's list of drugs to negotiate prices concessions, Bloomberg reported. The company told USA TODAY that it would ...

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 ...

The Boston-based drugmaker heard back from the FDA ahead of its scheduled Prescription Drug User Fee Act deadline on its so-called “vanza triple.” The federal agency approved the new CF ...