- Investor's Business Daily
Dow Jones Powerhouse Merck Dives On Surprise FDA Rejection
Merck stock tumbled under its 50-day moving average Thursday after the FDA rejected its Daiichi Sankyo-partnered cancer drug.
- Zacks
Merck's (MRK) Lung Cancer Candidate Faces FDA Rejection
The FDA's CRL to Merck (MRK) and its partner Daiichi Sankyo for the patritumab deruxtecan BLA is based on observations made on inspection of a third-party manufacturing facility.
- Benzinga
FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug
On Wednesday, the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) and Merck & Co Inc’s (NYSE:MRK) patritumab deruxtecan (HER3-DXd) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The CRL results from findings about an inspection of a third-party manufacturing facility. The CRL
