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STAT+: Tracking the FDA expert review of Replimune’s melanoma treatment
['Matthew Herper', 'Elaine Chen', 'Matthew Herper Covers Medical Innovation', 'Both Its Promise', 'Its Perils.', 'Elaine S Stories Explore The Boom In New Obesity Treatments', 'New Drug Payment Models', 'The Ways Companies Are Affected Fda Changes', 'The Emerging Psychedelics Drug Sector. She Co-Writes', 'Senior Writer']
STAT
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 .
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.
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.