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The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended fifteen drugs for approval at its first meeting of the year, including four generics and one biosimilar. Read More
Priority review vouchers (PRVs) may have little to no effect on drug development, the Government Accountability Office (GAO) concluded in a report released on Friday — although some drugmakers surveyed said otherwise. Read More
Genus Lifesciences has filed suit against the FDA in the U.S. District Court for the District of Columbia, alleging that the agency violated the 5-year exclusivity of a Genus product in approving a competitor’s application for a rival product. Read More