SpringWorks Therapeutics Has Completed The Submission Of A New Drug Application To The FDA For Mirdametinib For Pediatric And Adult Patients With Neurofibromatosis Type 1- Associated Plexiform Neurofibromas
Portfolio Pulse from Benzinga Newsdesk
SpringWorks Therapeutics has submitted a New Drug Application to the FDA for mirdametinib, targeting pediatric and adult patients with Neurofibromatosis Type 1-Associated Plexiform Neurofibromas. The company also plans to file a Marketing Authorization Application with the European Medicines Agency in the second half of 2024.
July 01, 2024 | 10:32 am
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SpringWorks Therapeutics has submitted a New Drug Application to the FDA for mirdametinib, which could significantly impact the company's market position if approved. The company also plans to file for approval in Europe in the second half of 2024.
The submission of a New Drug Application to the FDA is a significant milestone for SpringWorks Therapeutics. If approved, mirdametinib could open up new revenue streams and enhance the company's market position. The planned filing with the EMA further indicates the company's strategic expansion into the European market.
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