The supplemental New Drug Application is supported by data from the Phase II TRANSCEND FL trial (NCT04245839), which showed ...

Based on positive Phase II TRANSCEND FL data showing a 95.5% overall response rate, the FDA has accepted Bristol Myers Squibb’s sBLA for Breyanzi in relapsed or refractory MZL with a PDUFA date set ...

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted ...

The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for AstraZeneca’s supplemental Biologics ...

Sprout Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its ...

Based on durable response data, TAR-200 has been given priority review for the treatment of patients with high-risk ...

Denali Therapeutics Inc. (NASDAQ:DNLI) is a clinical-stage biopharmaceutical company headquartered in South San Francisco, ...

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or ...

COPENHAGEN, Denmark, July 31, 2025 - Bavarian Nordic A/S (OMX: BAVA) today announced the completion of the sale of its ...

The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca's supplemental biologics licence application (sBLA) for Imfinzi (durvalumab), a human monoclonal antibody, for ...