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Keeping Track: TGT’s Ukoniq Is Latest PI3K Inhibitor To Fall; GSK’s Daprodustat, Aeglea’s Pegzilarginase Headline Submissions

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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PI3K Inhibitors For Hematology Indications Need Randomized Data, FDA Panel Says

Vote can be seen as an endorsement of the Oncology Center of Excellence’s push for use of a single, ongoing randomized trial to serve as the basis for both accelerated approval and confirmatory evidence. OCE director Richard Pazdur says agency will be flexible in applying randomization requirements to future drugs that have a cleaner safety profile.

Teva Denied On LAI Risperidone But Expected To Bounce Back ‘Quickly’

Development partners Teva and MedinCell are not licking their wounds after being denied USFDA approval for their proposed 505(b)(2) hybrid risperidone long-acting injectable product.

GSK Can Seize Chance In Anemia After Rivals Rejected But FDA Caution Will Remain

GSK’s drug is the first in the class to show non-inferiority to standard therapy in safety, but the data still contains areas of doubt.

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