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AstraZeneca and Nektar Therapeutics say they hope to market their newly approved opioid-induced constipation drug Movantik in early 2015, but the launch date remains uncertain as the Drug Enforcement Administration considers a request to deschedule the product. Read More
The FDA has again rejected Amarin’s appeal for the agency to reinstate a special protocol assessment (SPA) on a phase III study of its triglyceride drug Vascepa, a move that casts doubt on the drugmaker’s ability to expand its indication on the fish oil-based product. Read More
The European Medicines Agency wants to help manufacturers take advantage of its adaptive licensing pilot program, which aims to speed patient access to new treatments via a process that authorizes products for use by targeted populations in stages. Read More