British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority ...

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

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 ...

Durvalumab's breakthrough therapy designation offers hope for improved outcomes in early-stage gastric and GEJ cancers, ...

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 ...

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, ...

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 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' ...

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

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 ...