Boehringer Awarded FDA Commissioner's National Priority Voucher for HERNEXEOS® in HER2 Lung Cancer

Boehringer awarded FDA Commissioner's National Priority Voucher for HERNEXEOS® in HER2 lung cancer

RIDGEFIELD, Conn., Nov. 7, 2025 /PRNewswire/ -- The U.S. Food & Drug Administration (FDA) has awarded a Commissioner's National Priority Voucher (CNPV) for HERNEXEOS® (zongertinib tablets), currently under investigation for first-line use in treatment-naïve patients with HER2 (ERBB2)-mutant advanced non-small…

FDA Awards More Vouchers for Quicker Drug Reviews

The Food and Drug Administration on Nov. 6 awarded six companies vouchers that will accelerate the review process for their products. “National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” Dr. Marty Makary, the FDA’s commissioner, said in a statement. “We are pioneering new ways o…

Zongertinib, dostarlimab chosen in second batch of National Priority Vouchers recipients

FDA announced six additional awardees under the Commissioner’s National Priority Voucher pilot program, which aims to accelerate review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, Oct. 24, June 20, 2025). This content is for Group 1 - Individual Seat, Individual Subscription - Annual ($555), Individual Subscription - Monthly ($55), Introductory Subscription - non-renewing ($60), and Sponso…