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
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat
Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.
Asia Deal Watch: Nippon Shinyaku Acquires US Rights To Capricor’s DMD Drug
Plus deals involving Aculys/Neurelis, Xtalpi/Excelra, Abbisko/Lilly, Daiichi Sankyo/Cosette, Mitsubishi Tanabe/ADC Therapeutics and PersonGen/Transgene.
US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development
Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.