FDA Awards Fast-Track Voucher for Kids' Rare Disease Drug
Published Date: 8/28/2025
Notice
Summary
The FDA just gave a special fast-track ticket called a priority review voucher to Chimerix, Inc. for their rare pediatric disease drug, MODESYO (dordaviprone), approved on August 6, 2025. This voucher helps speed up future drug reviews, benefiting companies working on rare kids' diseases and potentially getting treatments to patients faster. It’s a big win for rare disease drug developers and could impact how quickly new medicines reach the market.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Faster Reviews Could Reach Patients Sooner
The FDA says the priority review voucher helps speed up future drug reviews and could help get treatments for rare pediatric diseases to patients faster. The voucher was awarded for MODESYO (dordaviprone), approved August 6, 2025.
Priority Review Voucher Awarded to Company
The FDA issued a priority review voucher to Chimerix, Inc. for their rare pediatric disease product MODESYO (dordaviprone), which was approved on August 6, 2025. The voucher is an FDA-authorized tool that helps the sponsor speed up a future drug review.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-12577 — Agency Information Collection Activities; Proposed Collection; Comment Request; Potential Tobacco Product Violations Reporting Form
The FDA wants your thoughts on a new form to report possible tobacco product rule-breakers. This affects anyone who might spot tobacco violations and helps the FDA keep products safe. You’ve got until August 24, 2026, to share your comments—no cost to you, just your voice!
2026-12579 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity, Form FDA 3975
The FDA is asking for approval to keep using Form FDA 3975, which helps confirm who you are when you ask for your own records under the Freedom of Information Act or Privacy Act. If you want your personal info from the FDA but didn’t prove your identity well enough, this form steps in. Comments on this plan are open until July 23, 2026, and there’s no new cost for you—just a smoother way to get your info!
2026-12444 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
The FDA is officially putting the endoscopic light-projecting measuring device into Class II, meaning it now has special safety rules but fewer hurdles than the strictest category. This change helps make sure the device is safe and effective while speeding up patient access to cool new tech. The new rules took effect June 22, 2026, and could save time and money for makers and users alike.
2026-12367 — Epizyme, Inc.; Withdrawal of Approval of New Drug Application for TAZVERIK (Tazemetostat) Tablet, 200 Milligrams
Epizyme, Inc. has asked the FDA to withdraw approval for their cancer drug TAZVERIK (200 mg tablets), effective June 22, 2026. This means TAZVERIK will no longer be officially approved for treating certain sarcomas and lymphomas, affecting patients and healthcare providers relying on it. The change might impact treatment options and insurance coverage, so folks should check with their doctors about next steps.
2026-12445 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
The FDA is officially putting the endoscopic traction device into Class II, meaning it now has special safety rules but fewer hurdles than the strictest category. This change helps make sure the device is safe and effective while making it easier for patients to get access to this cool medical tool. The new rules took effect on June 22, 2026, and could speed up innovation without extra costs for makers.
2026-12443 — Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
The FDA is officially putting a simple test that spots proteins from Bacillus bacteria in human samples into a safer, easier-to-manage category called Class II. This change helps make sure the test is safe and works well while speeding up patient access to cool new medical tools. The new rules kicked in on June 22, 2026, but have been in effect since February 3, 2023, making life simpler for device makers and patients alike.
Previous / Next Documents
Previous: 2025-16514 — Patient-Focused Drug Development: Workshop #2 To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments
The FDA is hosting a fun and important workshop to tackle tricky questions about how to collect and use patient experience data when developing new medicines. This event helps patients, drug makers, and doctors work together to make treatments better and more patient-friendly. If you care about medicine that fits real people’s needs, this is your chance to join the conversation and shape the future!
Next: 2025-16516 — In the Matter of Martina Juanita Gil, 2721 E. Caldwell Street, Phoenix, AZ 85042; Order Denying Export Privileges
Martina Juanita Gil from Phoenix got caught smuggling thousands of bullets from the U.S. to Mexico and was sentenced to over a year in prison plus supervised release. Because of this, her right to export goods is blocked for five years starting from her conviction date, and any export licenses she had are canceled. This means she can’t legally send stuff out of the country for a while, impacting her business activities.