Lilly To Decide Next Steps After Formal FDA 'Nay' For First Chinese PD-1
A Chance To Reflect?
Executive Summary
The official verdict is in for sintilimab and the results are not surprising. But some view the setback for "Made In China" innovation as a chance to reflect and move forward.
You may also be interested in...
EQRx Confronts US Drug Development Realities, Shifts Pricing Approach
Because of FDA requirements for studies applicable to US patients, EQRx ended US development of its PD-1 inhibitor and will launch its EGFR and CDK4/6 inhibitors at market-based prices.
EQRx Confronts US Drug Development Realities, Shifts Pricing Approach
Because of FDA requirements for studies applicable to US patients, EQRx ended US development of its PD-1 inhibitor and will launch its EGFR and CDK4/6 inhibitors at market-based prices.
Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?
Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.