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FDA’s uniQure, REGENXBIO reversals could bolster other near-term rare disease applications

BioSpace

The FDA's recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Bio

Rare Disease

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pharminent June 25, 2026 (Last updated: June 29, 2026)

BioSpace

The FDA’s recently altered outlook on the evidence required for approval of rare disease drugs could have immediate benefits for companies including Skyhawk Therapeutics, Capricor Therapeutics and Bio

Rare Disease

Read full story

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