Hot Spots In 2023: US FDA Goal Dates Portend Battles In Diseases From RSV To Ulcerative Colitis
Novel agents targeting similar indications suggest potential commercial struggles across the therapeutic landscape, with battlegrounds taking shape between RSV vaccines, new mechanisms in major depression, and bispecifics for large B-cell lymphoma.
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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.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The FDA and Sarepta have had a controversial history with the accelerated approvals of the firm’s earlier drugs for Duchenne muscular dystrophy – but the company’s investigational gene therapy, SRP-9001, now under a priority review, could be a genuine breakthrough.