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The FDA approved 46 novel drugs in 2017, hitting a two-decade high after approvals plunged in the previous year — a record 53 novel drugs were approved in 1996. Read More
The FDA approved Spark Therapeutics’ novel gene therapy to treat an inherited form of vision loss — making it the first genetic therapy approved in the U.S. to target a disease caused by a specific gene’s mutations. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended ten medicines for approval, including two orphan medicines and a new treatment for multiple sclerosis. Read More
The FDA issued two draft guidances to encourage using the 510(k)-Clinical Laboratory Improvement Amendments (CLIA) waiver dual application pathway for new in vitro diagnostic devices, and to update its policies for demonstrating accuracy to obtain a CLIA designation. Read More