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Archive for April, 2015

28
Apr

Merck execs used their quarterly review today to confirm that the troubled drug Bridion (sugammadex) has once again been rejected at the FDA. This is the drug’s third stiff arm at the agency. …read more Source: FDA bats down Merck’s sugammadex in third rejection     

27
Apr

An internal FDA review of Amgen’s study of its cancer-killing virus talimogene laherparepvec (T-Vec), released Monday morning, raises red flags for this drug, presenting some thorny questions for the company’s regulatory team to answer. …read more Source: UPDATED: FDA review challenges Amgen on a questionable T-Vec study     

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