FDA panel greenlights first OTC birth control; documents show FDA reviewer concerns about Sarepta gene therapy

Taking stock of the drug industry, from the lab to the medicine chest

May 10, 2023 Check out STAT+

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By Ed Silverman Pharmalot Columnist, Senior Writer

JIM WATSON/AFP via Getty Images FDA panel votes in favor of the first over-the-counter birth control pill An FDA panel recommended the first-ever OTC birth control pills, which could transform how contraception is delivered in the U.S. By Ed Silverman STAT+ | FDA reviewers had string of concerns about Sarepta's gene therapy for Duchenne, documents show FDA staff believe Sarepta's clinical studies "conducted to date do not provide unambiguous evidence" on the therapy, the documents show. By Jason Mast and Adam Feuerstein STAT+ | In small study, weight loss drug boosts immune cells that help fight cancer A small new study suggests the benefits of drugs like Wegovy and Ozempic may go beyond just cutting weight. By Elaine Chen Adobe Opinion: Three misconceptions about the accelerated drug approval pathway Major misconceptions about the accelerated approval pathway are harming the proper regulation of rare disease treatments. By Emil D. Kakkis and Camille Bedrosian

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