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Latest From Evive Biotech

New Oncologics Overwhelmingly Approved In US Before EU

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Regional Comparisons Approvals

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regional Comparisons Approvals

BeiGene’s Tevimbra And The End Of The COVID Inspection Era

US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.

US FDA Performance Tracker Approvals

EMA Turns Down Minoryx’s Orphan Drug Nezglyal & Apellis’ Syfovre, OKs Three Others

The European Medicines Agency has recommended against the pan-EU marketing approval of two new medicines, while three others received positive opinions on marketing authorization.

BioPharmaceutical Approvals
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  • Other Names / Subsidiaries
    • Generon (Shanghai) Corporation Ltd
    • Generon BioMed Holding Ltd.
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