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Cancer · United StatesIn a significant stride within the realm of oncology, Bicara Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its investigational therapy, ficerafusp alfa, for the treatment of first-line human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This designation, which aims to expedite the development and review of the…See the Story
Bicara Therapeutics Ficerafusp Alfa Secures FDA Breakthrough Designation A Promising Horizon for HPV-Negative R/M ...

Health · United States'SAN CARLOS, Calif. '' BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a pioneering global oncology company, has announced a significant milestone in its clinical development programme. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, an advanced and potentially best-in-class investigational BCL2 inhibitor. This designation is aimed at improving treatment options for ad…See the Story
BeOne Medicines Secures FDA Breakthrough Therapy Designation for Sonrotoclax in Treating Mantle Cell Lymphoma,
