Keeping Track: A Blizzard Of Submissions At The US FDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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GSK Tries To Chase Down Pfizer With Phase III Pentavalent Meningococcal Vaccine Data
Phase III data for a vaccine combining Bexsero and Menveo demonstrated non-inferiority. GSK hopes to file it for approval soon, while Pfizer’s candidate has an October FDA action date.
Dispute Resolution: Ardelyx Eyes Tenapanor Resubmission Following Successful Appeal To FDA
Office of New Drugs grants company’s appeal of complete response letter for tenapanor in dialysis patients, marking a rare sponsor victory through the agency’s formal dispute resolution process; new drug application resubmission is targeted for first half of 2023.
Broad Heart Failure Label Ushers Lexicon’s Inpefa Into SGLT2 Inhibitor Market
Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.