Sanofi Nabs Priority Review For New Pompe Drug
And Rilzabritib Gets US Fast Track For ITP
The French drugmaker's follow up to Myozyme – avalglucosidase alfa – is in line for a potential US approval by May next year after the US FDA agreed to a speedy review of the enzyme replacement therapy, unlike its European counterparts.
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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.
Another UK biotech has been swallowed up by a big pharma with Sanofi acquiring the Cambridge-based firm in a deal that could be worth almost $1.5bn.
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.