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US FDA Performance Tracker Approvals Drug Approval Standards

Keeping Track: Regeneron Wins US FDA OK For Evkeeza, New Libtayo Uses; G1 Cosela Cleared

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Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Latecomer Libtayo Wins Coveted First-Line NSCLC Monotherapy Indication

Sanofi/Regeneron's PD-1 inhibitor Libtayo joins Keytruda and Tecentriq as the only PD-1/L1s approved by the US FDA as monotherapy for first-line non-small cell lung cancer.

Regeneron's Evkeeza Approved For Ultra-Rare Genetic High Cholesterol – And Priced To Match

Evkeeza is the first ANGPTL3 approved by the FDA; Regeneron scientists discovered the angiopoetin gene family.

Genmab Commercial Expansion Opens The Door To New Types Of Deals

The company's CEO talked to Scrip about the expected US launch of tisotumab vedotin likely later in 2021 and the company's partnering strategy going forward.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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