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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EU Decision Time For Zejula/Zytiga Combo Therapy, Vadadustat & Other Drugs
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.
BMS’ Plaque Psoriasis Drug Deucravacitinib Among Six Hopefuls Awaiting EMA Verdict
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.
Sobi To Start Selling Zynlonta After Sealing EU Approval
Five months after paying $55m upfront to Switzerland's ADC Therapeutics, Sobi has been granted conditional marketing authorization for Zynlonta for the treatment of relapsed or refractory diffuse large B-cell lymphoma.