BioNTech’s Oncology Pipeline Gains Momentum with Key Regulatory Designation
31.01.2026 - 13:11:05 | boerse-global.de
A significant regulatory milestone has been achieved by BioNTech in the United States, providing fresh impetus for one of its core cancer programs. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s candidate BNT113, signaling a commitment to expedite the development and review process for this therapy.
The FDA’s decision, announced on January 21, applies to BNT113 as a potential treatment for patients with HPV16-positive head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. This regulatory status is not a guarantee of eventual approval but is intended to facilitate Read more...
US09075V1026 | BIONTECH’S
