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
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Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
Sandoz and Polpharma have quickly followed news of a European natalizumab filing with confirmation that the proposed biosimilar version of Tysabri has also been accepted for review by the US Food and Drug Administration.
Polpharma Biologics has claimed the first biosimilar natalizumab filing in Europe, after the European Medicines Agency accepted the firm’s marketing authorization application for review.