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 ...
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 years ...
The FDA has approved an oral, small molecule MEK inhibitor for adult and pediatric patients 2 years of age and older with ...
SpringWorks Therapeutics Inc. (SWTX) shares surged more than 10% in Wednesday’s after-hours, signaling strong investor ...
Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively ...
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 ...
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 is the first FDA-approved treatment for adult and pediatric NF1-PN, showing effective tumor reduction and manageable safety. SpringWorks Therapeutics has announced the FDA approval of ...
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 ...