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

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

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 ...

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

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

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

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

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National ...

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 ...

The Food and Drug Administration (FDA) has granted Priority Review to TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder ...

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).