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A number of drugmakers got good news from the European Medicines Agency’s Committee for Medicinal Products for Human Use, including two companies looking to have their lung cancer candidates approved in Europe. Read More
The FDA’s first public meeting on the 2017 reauthorization of the Biosimilars User Fee Act brought calls for increased transparency in terms of how the agency regulates biosimilars and a rethinking of how these products will be named. Read More
President Barack Obama signed into law on Friday the fiscal 2016 omnibus spending bill, which contains $4.68 billion in total funding for the FDA. Read More
Turing Pharmaceuticals CEO Martin Shkreli has been indicted on seven counts of securities and wire fraud for alleged conduct at several of his previous companies. Read More
Drugmakers that have not started complying with worldwide track and trace regulations are behind the eight ball, as most companies only allow for two to three years for implementation, a supply chain expert warns. Read More
A sweeping deal to keep the government running through next fall is expected to come to a vote Friday, under which the FDA would be awarded $4.68 billion in total funding for fiscal year 2016. Read More
The FDA is recommending that drugmakers create safety assessment committees and formalized surveillance plans to watch for serious adverse events in clinical trials to decide when safety data should be unblinded. Read More
Eli Lilly scored a win at the FDA Wednesday, with the agency approving the company’s insulin glargine injection, Basaglar, to improve glycemic control in patients with Type 1 and 2 diabetes. Read More
The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. Read More
With the clock about to strike midnight on 2015, CDER Director Janet Woodcock laid out a set of priorities the center will focus on in 2016, with negotiating new PDUFA and GDUFA agreements topping that list. Read More