FDA names 9 first recipients of 1- to 2-month priority review vouchers
7.0
来源：
FiercePharma
发布时间：
2025-10-17 04:50
摘要：
FDA has initiated a priority review voucher program, awarding nine companies, including Regeneron for its gene therapy DB-OTO, which targets a rare genetic hearing loss. This program aims to expedite the approval process for drugs that meet significant health needs, with a focus on affordability. Other recipients include RMC-6236 for cancer treatment and various drugs addressing smoking cessation and fertility. The initiative reflects a strategic push by the FDA to enhance drug accessibility and support domestic production.
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domain_focus
1.0
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1.0
scientific_rigor
1.0
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1.5
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2.5
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1.0
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关键证据
Regeneron plans to seek FDA approval this year for DB-OTO, a gene therapy for hearing loss.
RMC-6236 is in phase 3 development for pancreatic and lung cancer.
FDA's priority review program aims to reduce approval times for critical medicines.
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AI评分总结
FDA has initiated a priority review voucher program, awarding nine companies, including Regeneron for its gene therapy DB-OTO, which targets a rare genetic hearing loss. This program aims to expedite the approval process for drugs that meet significant health needs, with a focus on affordability. Other recipients include RMC-6236 for cancer treatment and various drugs addressing smoking cessation and fertility. The initiative reflects a strategic push by the FDA to enhance drug accessibility and support domestic production.