drug approval

Fierce Pharma

Regeneron ushers in new era with inaugural gene therapy approval

The FDA today approved the company’s Otarmeni, the first gene therapy for a rare genetic form of hearing loss that affects about 50 newborns per year.

Darren Incorvaia Apr 23, 2026 3:22pm

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Unpacking the FDA transparency push on CRLs

Oct 17, 2025 9:41am