Keeping Track: US FDA Receives Advanced Biologic BLAs From ImmunityBio, CSL; Nymox, Medac Stumble
The latest NDA and BLA submission news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Keeping Track: Showers Of Approvals In US FDA’s May Forecast
Upcoming user fees include 16 novel agents, featuring two RSV vaccines, two gene therapies, and three oncologics. The Pink Sheet’s US FDA Performance Tracker breaks down the big month to come.
Finance Watch: Aileron, Talaris, Frequency And The Search For Strategic Alternatives
Public Company Edition: Aileron, Talaris and Frequency said they will reduce expenses and seek options for maximizing shareholder returns under tough stock market conditions. However, CureVac and Supernus are among firms recently able to access new cash – $250m and $150m, respectively.
Sanofi/Sobi’s Next-Gen Factor VIII Therapy BLA Heats Up Biotech-Driven Hemophilia Arms Race
Sanofi/Sobi’s efanesoctocog is in line for US FDA action three months after CSL/uniQure’s gene therapy user fee goal, while BioMarin’s Roctavian resubmission and Novo Nordisk’s concizumab are waiting in the wings.