British drugmaker GSK said on Monday its supplemental new drug application for antibiotic drug gepotidacin has been accepted for priority review by the U.S. Food and Drug Administration for the oral ...

FDA prioritizes review of liso-cel, a groundbreaking CAR T-cell therapy for relapsed marginal zone lymphoma, promising ...

The supplemental Biologics License Application for the gastric/GEJ cancer indication is supported by data from the double-blind, placebo-controlled MATTERHORN trial.

Epcoritamab shows promising results in treating relapsed follicular lymphoma, with FDA priority review for a groundbreaking ...

Epkinly with Rituxan and Revlimid, compared to Rituxan and Revlimid alone, reduced risk of progression or death by 79%.

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 ...

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

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

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

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

The promising results, along with a separate FDA decision, could signal a major expansion of the use of the two companies' ...