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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A Phase II study in a frail, older lymphoma population has seen seven respiratory-related deaths along with five other serious adverse events, but so far Zynlonta has been deemed not related to the AEs.
The European Medicines Agency’s human medicines committee, the CHMP, is this week deciding whether to back the approval of a number of new drugs.
A novel TYK2 inhibitor and a drug to treat an ultra-rare genetic disorder are among products up for a marketing authorization opinion this week from the European Medicines Agency’s human medicines committee, the CHMP.