SpringWorks Therapeutics Inc.
http://www.springworkstx.com
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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.
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.
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.
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.
Company Information
- Industry
- Biotechnology
- Pharmaceuticals
- Other Names / Subsidiaries
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- MapKure, LLC
- SpringWorks Therapeutics, LLC
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