The FDA has approved an oral, small molecule MEK inhibitor for adult and pediatric patients 2 years of age and older with ...
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat ...
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult ...
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data ...
SpringWorks Therapeutics Inc. (SWTX) shares surged more than 10% in Wednesday’s after-hours, signaling strong investor ...
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
Mirdametinib is an inhibitor of mitogen-activated protein kinase kinases 1 and 2. Gomekli is the first medication approved for both adult and pediatric patients with NF1-PN. The Food and Drug ...
SWTX reports mixed fourth-quarter 2024 results. Its newly approved desmoid tumor drug, Ogsiveo, witnesses a strong launch.
Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively ...
For pricing, Gomekli dosing and cost will vary based on the body surface area of each patient, which takes into account both height and weight. SpringWorks has set a wholesale acquisition cost for ...