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Another Indian drugmaker is in hot water with the FDA, with Sun Pharma’s Halol, Gujarat, facility earning a warning letter for a lack of sterility assurance and validation of the sterility system. Read More
The proposed transaction would consist of an exchange of Sanofi’s Merial animal health business and Boehringer’s consumer healthcare business. Read More
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 is postponing its decision on BioMarin’s investigational drug drisapersen for Duchenne muscular dystrophy, saying the review is still under way. 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