FDA’s Janet Woodcock to retire early next year

STAT News, November 16, 2023: Principal Deputy FDA Commissioner Janet Woodcock will retire from the FDA in early 2024 after almost 40 years at the agency, many as a powerful and controversial leader. We explain how her legacy has tarnished the FDA’s reputation.

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After Drug Trial Fizzles, Sarepta Still Seeks Broad Approval

Bloomberg News, November 1, 2023: Sarepta’s gene therapy Elevidys failed to confirm efficacy for Duchenne Muscular Dystrophy. Will FDA convert accelerated approval to full approval anyway? We explain why that would be ridiculous, but not impossible. But who will pay for an unproven treatment that costs $3.2 million per patient?

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