Matthew Herper covers medical innovation — both its promise and its perils.

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

A group of outside experts convened by the Food and Drug Administration on Thursday voted in favor of Replimune’s experimental treatment for advanced melanoma.

In a 10-3 vote, the advisers determined that the biotech company has collected sufficient data to allow the FDA to review RP1, an engineered viral immunotherapy for melanoma. The agency tends to follow the recommendations of its expert panels but is not bound by them.

What comes next could be seen by some as a signal of how the FDA, under new leadership, weighs potential benefits and risks when it comes to investigational drugs. RP1 was initially rejected last year, under former FDA leaders Marty Makary and Vinay Prasad. But STAT reported that earlier resistance to RP1 was based on the views of former top oncology regulator Rick Pazdur. The drug was again rejected this April.

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   Senior Writer, Medicine, Editorial Director of Events

   Matthew Herper covers medical innovation — both its promise and its perils.

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   National Biotech Reporter

   Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.