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Tag: Accelerated Approval Program

FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors

Accelerated Approval Program, Drug, Drugs, FDA, Pediatric, post-marketing studiesFDA

On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by …

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