FDA Hands Out Fast-Track Voucher for Disease-Fighting Drug
Published Date: 4/23/2025
Notice
Summary
The FDA just gave Ridgeback Biotherapeutics a special priority review voucher for their EBANGA medicine, which helps protect against serious health threats. This voucher speeds up future drug reviews, making it easier and faster to get important medicines approved. It’s a big win for public health and shows the FDA’s commitment to fighting dangerous diseases quickly.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Priority Review Voucher Awarded to Ridgeback
The FDA awarded a priority review voucher to the sponsor Ridgeback Biotherapeutics for EBANGA (ansuvimab-zykl) for injection, which the FDA says met the material threat medical countermeasure criteria. EBANGA was approved on December 21, 2020, and the voucher can be used by the sponsor to obtain priority review for a future drug application.
Faster Reviews Could Speed Access to Medicines
The FDA says the priority review voucher is for a material threat medical countermeasure and can be used to obtain priority review for future drug applications, which speeds up future drug reviews and can make it easier and faster to get important medicines approved.
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