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The European Medicines Agency plans to issue a “go-live” strategy for regulators, drug companies and other stakeholders in the run-up to the Nov. 22 launch of an upgraded EudraVigilance system for reporting adverse drug reactions. Read More
The UK National Institute for Health and Care Excellence ruled that Merck’s cancer immunotherapy Keytruda is not cost-effective in metastatic urothelial carcinoma. Read More
Ahead of the program’s expiration in September, the FDA has finalized a question-and-answer guidance for GDUFA I covering ANDA reviews, inspections and self-identification of facilities. Read More
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More