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In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
The FDA and European Medicines Agency took differing views on multiple melanoma injections up for approval, with the U.S. agency rejecting Spectrum Pharmaceuticals’ Evomela and the EMA’s scientific experts recommending approval of Amgen’s Imlygic. Read More
The FDA Friday approved Alexion Pharmaceuticals’ Strensiq for the first-ever treatment of hypophosphatasia, a rare genetic metabolic disorder that weakens bones. Read More
The FDA has approved Merrimack Pharmaceuticals’ Onivyde, the first and only treatment for patients with advanced pancreatic cancer whose disease progressed after getting chemotherapy with gemcitabine. Read More