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SpringWorks Therapeutics Inc.

http://www.springworkstx.com

Latest From SpringWorks Therapeutics Inc.

New Oncologics Overwhelmingly Approved In US Before EU

Ninety-five percent of novel cancer treatments approved in both the US and Europe received the FDA’s OK first, but Europe usually followed within a year, a Pink Sheet analysis shows.

Regional Comparisons Approvals

Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

Regional Comparisons Approvals

GSK Gets RSV Vaccine Expansion To Younger Adults

Arexvy was approved by the US FDA for adults 50-59 with medical conditions that put them at increased risk of severe RSV. Separately, the company ended a cancer deal with SpringWorks.

Approvals Vaccines

With One Launch Under Way, SpringWorks Ramps Up For A Second

The company initiated a rolling submission with the US FDA for mirdametinib, a MEK inhibitor that is poised to be its second commercial product for a rare disease.

Launches Business Strategies
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • MapKure, LLC
    • SpringWorks Therapeutics, LLC
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