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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FDA Thwarts Leo Pharma's US Launch Plans For Tralokinumab
A week after getting the thumbs-up from the CHMP for tralokinumab, the Denmark-based dermatology specialist has been hit by a complete response letter from US regulators requesting more data about a device component of the IL-13 inhibitor.
Chiesi's Commercial Hopes In US Hit By FDA Letter
Shares in Protalix sank more than 30% after the company received a complete response letter from US regulators for pegunigalsidase alfa for Fabry disease. No inspection of the company's manufacturing plant in Israel appears to be the main sticking point.
PD-1 Inhibitor Market Poised For A New Round Of Expansion: After GSK’s Jemperli Approval, US FDA Still Has Three Novel Candidates Under Review
Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.