Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
Six of 10 advisory committee members say Phase II CENTAUR trial cannot stand on its own to support approval at this time. However, patients and advocates say thousands will die if they have to wait for the Phase III PHOENIX trial to complete in 2024 before the drug becomes widely available.
Advisory committee review of combo with ublituximab may provide forum to discuss the Phase III data showing increased risk of death that prompted US FDA safety alert.
Fresenius Kabi insists there is a “business plan behind everything” as it divulged a higher cost savings goal for the end of next year, following a fruitful 2023. But queries over margins led the company to stress that it was combatting a variety of uncertainties, especially in China and for its burgeoning biosimilars unit.