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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
The European Medicines Agency invited stakeholders to comment on a planned guidance on nonclinical development of radiopharmaceutical products. Read More
Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations. Read More