Type:Notice
Citation:90 FR 11992
Reading Time:about a minute or two
The Food and Drug Administration (FDA) has announced the issuance of a priority review voucher to SpringWorks Therapeutics, Inc. for their drug GOMEKLI (mirdametinib). This drug is used to treat adults and children 2 years and older who have neurofibromatosis type 1 with symptomatic plexiform neurofibromas. The priority review voucher is awarded under the Federal Food, Drug, and Cosmetic Act to incentivize companies to develop treatments for rare pediatric diseases. The notice was officially filed on March 12, 2025.
Simple Explanation
The FDA is giving a special prize to a company for making a new medicine called Gomekli, which helps kids and grown-ups with a rare health problem. This prize makes it quicker and easier for medicines to be checked and used.