When President Trump and HHS Secretary RFK Jr. rolled out Make America Healthy Again (“MAHA”), it sounded like a rebuke to Big Government and Big Pharma ambitions alike. But today, the FDA — ostensibly Mr. Kennedy’s regulatory anchor — has quietly become the firmest wall between gene-therapy breakthroughs and needy Americans.

Marty Makary’s leadership has shown us what happens when big ambitions outrun institutional capacity or courage.

Consider Replimune’s RP1 therapy: a potential advance in melanoma treatment that earned FDA breakthrough designation and showed a nearly 33% overall response rate in patients who had already failed PD-1 inhibitors.

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