11/12/2025 BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL BMS' sBLA for Opdivo + AVD received the FDA priority review for first-line cHL ( Ref )  The US FDA granted priority review status to Bristol Myers Squibb's sBLA for nivolumab (Opdivo; anti-PD-1) + doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated stage III or IV classical Hodgkin Lymphoma (cHL). The FDA assigned

09/12/2025 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies Zydus and Formycon enter into an exclusive partnership for the Keytruda biosimilar, FYB206 Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202 (logic gated off-the-shelf CAR-NK cell therapy) for the treatment of.

09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS ( Ref ) The US FDA granted the fast track...

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies ( Ref ) The US FDA accepted Orca...

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma ( Ref ) The US FDA granted...