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Latest From Kate Rawson
But US FDA is starting small, OCE Director Pazdur says. Program will hand-select approve high-priority oncology treatments that have to potential to change the standard of care.
First FDA-hosted workshop on rare family of mitochondrial diseases offers plenty of opportunities to talk challenges in R&D – and identify some solutions.
High price tag, thin evidence of clinical efficacy for Exondys 51 result in low score from ICER, but a re-do is almost certain when confirmatory data on eteplirsen are released.
US FDA has seen little success in ending gaming of the patent process by brand name manufacturers. One problem: the agency’s referrals to FTC on anti-competitive cases appear go into a black box.