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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
The FDA Wednesday approved Relypsa’s hyperkalemia therapy Veltassa — the company’s first product and the first advance in treating the life-threatening condition in more than five decades. Read More
FDA reviewers are questioning the safety and dosing of AztraZeneca’s investigational gout treatment lesinurad and whether a risk evaluation and mitigation strategy would suffice to address those concerns. Read More