Where Next For Sesen Bio’s Bladder Cancer Therapy Vicineum?
First-Mover Hopes Dashed By CRL
A complete response letter from the FDA has dashed Sesen Bio’s hopes of being first with a therapy for treating BCG-unresponsive non-muscle invasive bladder cancer. Its CEO says the FDA’s move may reflect heightened ‘pressure’ regulator is under.
You may also be interested in...
Public Company Edition: Bausch remains the majority shareholder, but B+L is a separate operating company. Also, Rezolute raises $130m in dual financings and BridgeBio outlines job cuts and will out-license assets to conserve cash.
Sponsors of three drugs have withdrawn their EU marketing authorization applications in the middle of the assessment process, including one for a bladder cancer therapy that was recently turned down in the US.
Keeping Track: Ticovac Is Latest Win For Pfizer’s Vaccine Business; Doors Open For BMS And GSK PD-1 Inhibitors
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.