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Keeping Track Of Breakthroughs: AZ Farxiga, ImmunoGen ADC For Hematologic Cancer, Inventiva NASH Candidate Earn Designation

Executive Summary

The latest breakthrough therapy designation news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase

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

April User Fee Goal Calendar: Forecast Uncertain For Atopic Dermatitis Candidates, Nuplazid; Eohilia Could Be First For Orphan Use

While some of the most prominent applications with user fee goal dates in April could be delayed, thanks to JAK inhibitor safety concerns and US FDA communications, the upcoming month should see more than 15 decisions on applications.

DAPA-CKD Data Put AstraZeneca’s Farxiga Out Front

A 39% relative risk reduction in the primary endpoint for the DAPA-CKD study and a 31% reduction in all-cause mortality prime Farxiga for a new chronic kidney disease indication following filings due in the next few months.

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