Tags : Yervoy

Regulatory

BMS Reports the US FDA Acceptance of sBLA for Opdivo

Shots: The US FDA has accepted sBLA for the dual regimen as 1L treatment for metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations and has granted the PR status to the therapy The application is based on part 1 of P-III CheckMate -227 study results assessing Opdivo + Yervoy vs platinum-doublet […]Read More

Biotech

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab)

Shots: The companies have submitted the sBLA for the combination therapy to expand its use as 1L treatment of unresectable, advanced/ recurrent NSCLC in Japan, for a partial change in approved items of the manufacturing and marketing approval The application is based on Part 1 of P-III CheckMate -227 study assessing the combination therapy vs […]Read More