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The FDA has rejected a single-dose version of AMAG Pharmaceuticals’ hormone injection Makena, requesting additional information from the company before making a decision on the product. Read More
The UK’s National Institute for Health and Care Excellence says it will not recommend Amgen’s Repatha as an option for people with high cholesterol and mixed dyslipidemia. Read More
The FDA has delayed Clovis Oncology’s bid to approve its new lung cancer treatment, asking for additional trial data that could see the March 30 PDUFA date extended. Read More
Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April. Read More