Straits Times Index
3,333.39 -9.96 (-0.30%) Nikkei
39,521.42 +179.88 (+0.46%) Hang Seng
17,774.50 +58.03 (+0.33%) FTSE 100
8,179.68 -45.65 (-0.55%) Bitcoin USD
61,503.07 +714.71 (+1.18%) CMC Crypto 200
1,283.29 -0.53 (-0.04%)
Daiichi Sankyo Co Ltd (D4S.MU)
- 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
- Business Wire
Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer
BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024--The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (TSE: 4568) and Merck’s (known as MSD outside of the United States and Canada) (NYSE: MRK) patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with tw
