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The European Medicines Agency has officially launched an electronic database for the safety reports all drugmakers are required to periodically submit on approved therapies. Read More
In a 46-page draft guidance released Monday, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
The FDA has given a Teva subsidiary the first greenlight for a generic Nexium in a snub to Ranbaxy, which is suing the agency after having its ANDA first-filer status on the therapy revoked over GMP violations at its India plants. Read More
Antares Pharma received an FDA complete response letter for labeling issues and minor deficiencies in its ANDA for sumatriptan injection USP, the company said in a Monday SEC filing. Read More
NPS Pharma plans to make Natpara available for some patients with hypoparathyroidism in the second quarter of this year, following FDA approval late Friday. Read More
UK healthcare cost watchdogs confirmed Friday that Bayer’s Xarelto is cost-effective for preventing blood clots in patients who have had heart attacks. Read More
Mylan has been awarded another $13.7 million in supplemental damages from GlaxoSmithKline in an ongoing lawsuit against the brandmaker that accuses it of violating a 2007 contract over exclusivity rights to generic antidepressant Paxil. Read More
Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More