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Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. Read More
China’s drug approval backlog ballooned to nearly 18,600 applications by the end of 2014, up more than 30 percent from December 2013, with generics applications representing most of the increase. Read More
The FDA has granted Shire’s dry eye treatment lifitegrast a priority review, cutting its NDA review time to six months rather than the usual 10 months. Read More
Novo Nordisk is moving forward two years after the FDA rejected two insulin therapies, with the agency’s agreement to review Class II resubmissions of its NDAs for Tresiba and Ryzodeg drugs based on an interim analysis of data from a cardiovascular outcomes study. Read More
The European Commission has approved Roche's Avastin plus chemotherapy for women with persistent, recurrent or metastatic cervical cancer, the company said Wednesday. Read More
The European Medicines Agency has approved a new use of Amgen’s Vectibix as first-line treatment in combination with Folfiri chemotherapy for metastatic colorectal cancer, the drugmaker said Monday.
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