Sanofi Stunned As FDA Says No To CAD Drug Sutimlimab
Deficiencies At Third-Party Manufacturing Facility
The French major's hopes for launching its rare blood disorder drug sutimlimab soon have been scuppered by a complete response letter from the FDA after inspecting a third-party facility responsible for making the first-in-class therapy.
You may also be interested in...
Enjaymo Marks Latest Milestone In Sanofi’s Blood Disorder Effort
The company plans to draw on experience with other rare blood disorder drug launches, but pointed to some differences in the market for cold agglutinin disease.
Nine Major Approval Decisions To Watch In Early 2022
Nine prominent drug candidates are awaiting an FDA approval decision in the next few months. With the help of Biomedtracker's Early 2022 Outlook Report, we take a look at the potential launches likely to shake up the market from HIV to wet AMD.
Sanofi Spotlights Nirsevimab In RSV, Further Dupixent Development
Sanofi executives are upbeat about the potential advantages of its monoclonal antibody-based approach to the prevention of RSV infections in infants, the future growth of the company’s Dupixent franchise, and the progress of its novel anticancers.