Company's application development seems to be outpacing FDA's policy development in next step along the 351(k) pathway.
Sandoz Inc.'s application package for its biosimilar to Amgen Inc.'s Enbrel continues to signal to FDA that the company is ready to move forward on interchangeability even if the agency is not.
A clinical study with multiple switches between GP2015 and its reference product was part of Sandoz's application to determine it...
Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
