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Latest From F2G Ltd
Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.
FDA Turns Down F2G’s Antifungal, But Firm Plots Comeback As Trial Completes Accrual
The US regulatory agency asked for more data and analyses for olorofim, which F2G hopes to provide from an ongoing Phase IIb study.
Shionogi Renews 10-Year Goal After Infectious Disease Success
Shionogi renews its 10-year strategic plan originally announced in 2020 following the successful debut of COVID-19 therapeutic Xocova. Fulfilling its 2025 goals ahead of schedule, its new strategy focuses on HIV and COVID-19 and new product launches.
US FDA’s June User Fee Calendar Starts Out Steady, But A Crescendo Of Decisions Will Start Mid-Month
Two gene therapies and two novel inhibitors of JAK kinases are among the upcoming goal dates from the Pink Sheet’s US FDA Performance Tracker.
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