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 ...

The FDA accepted a supplemental application for Breyanzi to treat adults with relapsed or refractory marginal zone lymphoma ...

Treatments for acromegaly, edema, HSCT-associated thrombotic microangiopathy, multiple sclerosis, and spinal muscular atrophy are under review.

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 ...

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

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 ...

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

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 ...

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