US Vs EU: First Half 2021 Novel Approval Scorecard
The Pink Sheet's table of the 55 novel products approved in either the US or EU during H1 2021 includes details on approval dates, use of special review pathways and review status such as orphan product or priority review.
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Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.
Keeping Track: Idorsia’s Quviviq Is FDA’s First Novel Approval Of 2022; AbbVie’s Rinvoq Gains Eczema Claim
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
An investigational CAR T-cell therapy that hospital researchers in Spain believe they could produce at a third of the price of commercially available CART19 products has been accepted onto the European Medicines Agency's priority medicines scheme.