Daiichi Sankyo and MSD have voluntarily withdrawn the biologics licence application (BLA) in the US for their HER3-directed ...

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

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 ...

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

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 ...

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 ...

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

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

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

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