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Stemline Therapeutics, Inc.

https://stemline.com/

Latest From Stemline Therapeutics, Inc.

EU New Drug Approvals Hit Record High

Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.

Pink Sheet Perspectives Europe

Driving Menarini's Future With Decisive Steps

Two years into her tenure as the head of Menarini, Elcin Barker Ergun has already inked two major cancer deals with the acquisition of Stemline and a key licensing pact with Radius Health. The future for the Italian group is bright, she explained to Scrip in an exclusive interview.

Leadership Business Strategies

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

EMA Doubles Number Of EU Early Access Approval Recommendations

The EU’s special provisions for speeding new products towards approval proved more popular than ever with drug sponsors last year.

Europe Approvals
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