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

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

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 ...

US FDA accepts for priority review Bristol Myers Squibb’s sBLA for Breyanzi to treat adult patients with relapsed or refractory MZL: Princeton, New Jersey Wednesday, August 6, 2 ...

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

FDA prioritizes review of tabelecleucel, a promising therapy for relapsed EBV+ PTLD, offering hope to patients with limited ...

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

The regulatory actions were based on results from the Phase III MATTERHORN trial (NCT04592913), which showed that a ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

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

Imfinzi plus chemo cut progression or death risk in early gastric cancer; the FDA's decision is expected late 2025 following breakthrough designation.

The FDA has granted Priority Review to TAR-200 for the treatment of patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors ...