SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

"We are pleased to be one step closer towards our goal of bringing mirdametinib to patients with NF1-PN in the U.S. and believe that our ReNeu data support the potential for mirdametinib to be a differentiated and best-inclass therapy for both children and adults living with this devastating disease," said Saqib Islam, Chief Executive Officer of SpringWorks. "We look forward to working closely with the FDA throughout the review process and also plan to file for regulatory approval in the European Union late ...