Findings from HERTHENA-Lung02 showed that the key secondary endpoint of overall survival did not meet statistical significance.

Candel Therapeutics, Inc. (NASDAQ:CADL) has secured FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its ...

Japan’s Daiichi Sankyo (TYO: 4568) and partner Merck & Co (NYSE: MRK) today revealed that the Biologics License Application ...

Merck (MRK) stock falls as the company withdraws U.S. marketing application for lung cancer therapy HER3-DXd developed with ...

Daiichi Sankyo & Merck voluntarily withdraws patritumab deruxtecan BLA to treat locally advanced or metastatic EGFR-mutated NSCLC from US FDA: Basking Ridge, New Jersey Friday, Ma ...

The BLA seeking accelerated approval for patritumab deruxtecan in previously treated, locally advanced EGFR-mutated NSCLC in ...

Meaningful efficacy observed in slow-progressor subgroup; NfL biomarker improvements support potential for accelerated ...

Anal cancer is relatively uncommon, accounting for approximately 2.5% of all gastrointestinal cancers. Nonetheless, its ...

After Merck paid a hefty sum to co-develop and co-commercialize HER3-DXd, the drug has suffered notable setbacks in ...

The FDA issued Thursday recommendations for replacing color additives in approved or marketed drug products, reminding the ...

Candel stock rises as FDA grants RMAT tag to CAN-2409 after phase III success in prostate cancer. BLA submission is planned at the end of 2026.

Intellia reports a grade 4 liver enzyme elevation in a Nex-Z trial patient; no hospitalization is required, and enrollment ...