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24.04.26 - 20:45
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FDA Approves First Gene Therapy To Treat Deafness (ZeroHedge)
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FDA Approves First Gene Therapy To Treat Deafness
Authored by Zachary Stieber via The Epoch Times (emphasis ours),
Federal regulators on Thursday approved the first gene therapy to restore hearing, just two months after the therapy's maker formally requested a license.
Dr. Marty Makary, the Food and Drug Administration's commissioner, in an undated file photograph. Madalina Vasiliu/The Epoch Times
The Food and Drug Administration approved the Regeneron therapy, Otarmeni, for children and adults with severe or profound hearing loss associated with OTOF gene variants.
The approval came 61 days after Regeneron filed for a biologics license, under a new effort known as the Commissioner's National Priority Voucher Program that emphasizes quickly reviewing applications for products that address unmet needs.
“Today's approval is a significant milestone in the treatment of genetic hearing loss,” Dr. Marty Makary, the FDA's commissioner, said in a statement.
“Through the national priority vo...
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23.04.26 - 18:01
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Regeneron Agrees to Lower Drug Prices, Gets Gene Therapy Nod (Bloomberg)
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Regeneron Pharmaceuticals Inc. reached a deal with the Trump administration to lower drug costs for some Americans and won US approval for its gene therapy to treat a rare form of deafness, according to a person who declined to be identified in order to speak before the announcement was made....
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