Personalized Medicines Top 2017 FDA Approvals including 11 new medicines for cancer - see full repor
Personalized Medicine at FDA: 2017 Progress Report documents the record number of new personalized medicines the U.S. Food and Drug Administration (FDA) approved in 2017, the fourth consecutive year that personalized medicines accounted for more than 20 percent of all new drug approvals.
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http://www.personalizedmedicinecoalition.org/Resources/Personalized_Medicine_at_FDA_An_Annual_Research_Report
The annual analysis shows that FDA approved a record number of 19 personalized medicines — 16 new molecular entities and three gene therapies — in 2017. The report lists a total of six regulatory precedents FDA set last year, as follows:
Record number of 16 personalized medicines approved as new molecular entities
Approval of first three gene therapies
First approval of a tissue agnostic indication for cancer therapy
First authorization for marketing of health-related genetic testsdirectly to consumers
First approval of a personalized medicine biosimilar
First FDA/CMS joint approval and coverage decision for a next-generation sequencing test
