Tag

National Priority Voucher

All articles tagged with #national priority voucher

health21 days ago•2 min saved

FDA Grants Seventh National Priority Voucher Approval for Bizengri in Rare NRG1 Fusion Cholangiocarcinoma

FDA approved Bizengri (zenocutuzumab-zbco) for adults with unresectable or metastatic NRG1 fusion–positive cholangiocarcinoma, the seventh approval under the Commissioner’s National Priority Voucher program. Efficacy comes from a 19-patient single-arm trial showing a 36.8% overall response; safety concerns include infusion-related reactions, interstitial lung disease/pneumonitis, and cardiac effects, with Breakthrough Therapy and Orphan Drug designations previously granted. A June 4, 2026 public meeting will discuss CNPV program details, with written comments due by June 29, 2026.

via fda.gov|

#bizengri #cholangiocarcinoma #fda

health2 months ago•2 min saved

FDA approves Wegovy HD, a higher-dose weight-loss option under a national priority program

The FDA cleared Wegovy HD (7.2 mg) for weight loss and long-term maintenance in adults with obesity or overweight plus a weight-related condition, marking the fourth approval under the Commissioner’s National Priority Voucher program. The higher dose yielded greater average weight loss with a safety profile consistent with prior semaglutide doses, though GI side effects were common and there is a boxed warning for thyroid C-cell tumors; the approval was granted to Novo Nordisk, and a June public hearing on the voucher program is planned.

via fda.gov|

#fda #health #national-priority-voucher

health3 months ago•2 min saved

FDA Grants Second National Priority Voucher-Driven Approval for Hernexeos in HER2-Mutant NSCLC

The FDA approved Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous NSCLC harboring activating HER2 (ERBB2) mutations, extending accelerated approval to first-line patients under the Commissioner's National Priority Voucher (CNPV) pilot program. The decision followed strong data showing 76% of untreated patients had substantial tumor shrinkage, higher than typical 30-45% responses, and came 44 days after filing on Jan 13, 2026. The move underscores fast-tracked review through the CNPV program, which also provides voucher-related benefits; the agency noted Breakthrough Therapy and Priority Review designations and highlighted safety risks such as hepatotoxicity and other common side effects.

via fda.gov|

#health #her2 #hernexeos