FDA Approves First-Ever Gene Therapy For Deafness, Opening Door To New Era

In a worldwide first, a one-and-done gene therapy has been approved to treat a form of hereditary deafness. Many of the ...
AOL

FDA approves first gene therapy for genetic hearing loss

The Food and Drug Administration on Thursday approved Regeneron’s Otarmeni, the first gene therapy for genetic hearing loss. The drugmaker said it will offer the drug for free to U.S. patients.

Health breakthroughs: FDA approves gene therapy that restores child hearing

Dr. Marty Makary noted it had "record speed approval," the fastest approval of any gene therapy device combination in U.S. history.
CNN

FDA approves first gene therapy for inherited deafness, shown to restore hearing for children with rare condition

The US Food and Drug Administration on Thursday approved the first gene therapy for inherited hearing loss, a one-time treatment that proved to be life-changing for a small number of children in a ...

FDA Approves First-Ever Gene Therapy to Restore Hearing

Regeneron’s drug restored hearing in 11 of 12 children in a rare, inherited condition that causes deafness.

The FDA gives the green light to the first gene therapy for deafness

The treatment, developed by Regeneron Pharmaceuticals, is for a very rare form of deafness. But it represents a medical milestone.
Earth Times

Gene Therapy Meets Regulatory Reality: The FDA–uniQure Clash Over a Promising Huntington’s Treatment

A new controversy surrounding the U.S. Food and Drug Administration (FDA) and biotechnology firm uniQure has ignited debate across the pharmaceutical industry about how breakthrough treatments should ...
Becker's Hospital Review

FDA approves 1st gene therapy for genetic hearing loss

The FDA has approved Otarmeni, the first gene therapy for genetic hearing loss, through its National Priority Voucher program. The therapy is indicated for pediatric and adult patients with ...