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The FDA moved one step closer to clearing the first biosimilar in the U.S. after agency staff recommended approval of Sandoz’s chemotherapy side-effect drug Zarzio, a version of Amgen’s blockbuster Neupogen. Read More
Halozyme Therapeutics’ pegylated recombinant human hyaluronidase last month won orphan drug designation for pancreatic cancer from the European Medicines Agency, marking the therapy’s second orphan drug win in 2014. Read More
A UK financial watchdog slammed Celgene’s pancreatic cancer drug Abraxane as too expensive and recommended against the English government reimbursing the therapy. Read More
The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More
Australia and New Zealand have abandoned plans for a joint drug and device regulatory authority, although both countries say they will continue to cooperate on mutually beneficial regulations. Read More
The FDA has acquiesced to industry concerns and promised not to take action against drug supply chain companies for failing to exchange product information before May 1. Read More
The FDA has pledged to delay enforcement of key elements of its new track and trace regulations for drugmakers, promising that until May 1 it will take no action against companies that do not capture and transmit product information. Read More
The European Medicines Agency released a comprehensive report detailing steps to better prevent and detect fraud and biased medical product reviews by 2016. Read More