Keeping Track: Two Targeted Oncologics And A Novel SGLT-2 Inhibitor Clear US FDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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A Greater Power: US FDA May Become More Insistent On Timing Of Accelerated Approval Confirmatory Trials
Bolstered by new statutory authority and the Oncology Center of Excellence’s experience in pushing for early initiation of confirmatory trials, review divisions may take a tougher line with sponsors on the design and timing of studies to verify clinical benefit.
With two SGLT2 inhibitors approved in the US and a third that may be able to overcome its recent US FDA rejection, it remains to be seen whether the type 2 diabetes market needs another drug in that class, but privately-held Theracos believes it has a differentiated product candidate that could overcome certain side effects.
CDC’s universal recommendation for XBB COVID vaccines means that Novavax’s protein-based vaccine can enter the market immediately upon FDA authorization, but some final questions from the agency are keeping the review going.