Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat ...
The FDA has approved an oral, small molecule MEK inhibitor for adult and pediatric patients 2 years of age and older with ...
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult ...
SpringWorks Therapeutics Inc. (SWTX) shares surged more than 10% in Wednesday’s after-hours, signaling strong investor ...
GOMEKLI was approved under Priority Review ... To report suspected adverse reactions, contact SpringWorks Therapeutics at 1-888-400-SWTX (1-888-400-7989) or FDA at 1-800-FDA-1088 or www.fda.gov ...
Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively ...
SpringWorks Therapeutics (SWTX) has announced that the U.S. Food and Drug Administration has approved GOMEKLI, a small molecule MEK inhibitor, for the treatment of adult and pediatric patients 2 ...
Reports FY24 revenue $191.5M, consensus $190.85M. “We are very pleased with the strong execution of OGSIVEO in 2024 and believe that we are ...
GOMEKLI was approved under Priority Review ... To report suspected adverse reactions, contact SpringWorks Therapeutics at 1-888-400-SWTX (1-888-400-7989) or FDA at 1-800-FDA-1088 or www.fda.gov ...