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

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

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Leo’s Tralokinumab Among 11 New Approval Hopefuls In EU

The developers of eleven new drugs could learn this week whether the European Medicines Agency will set them on course for pan-EU marketing approval.

Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J

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

Pivotal Moment In EU For Potential New Drugs

Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.

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