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Latest From Mayne Pharma Group Limited

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

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.

Approvals Review Pathway

Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa

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

US FDA Performance Tracker Approvals

Deal Watch: Chinook To Go Public Via Reverse Merger With Troubled Aduro

Focused on precision medicine for renal disease, Chinook gets Aduro’s Nasdaq listing and starting capital of $200m. During a wave of modest-sized M&A deals, Tetra finds buyer, Tetraphase gets competing bids.

Deals Business Strategies

Keeping Track: US FDA Clears Oncologics Tukysa And Jelmyto; Regeneron Anti-Ebola Cocktail Under Review

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

US FDA Performance Tracker Approvals
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