UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data ...
FiercePharma9d
Amid takeover talk, SpringWorks scores FDA nod for rare genetic disease treatment Gomekli
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Business Updates
Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively ...
SpringWorks sets wholesale acquisition cost for Gomekli at $206.25 per mg
SpringWorks Therapeutics (SWTX) has announced that the U.S. Food and Drug Administration has approved Gomekli, a small ...
US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
The Pharma Letter9d
FDA approves SpringWorks’ Gomekli
The US Food and Drug Administration approved Gomekli (mirdametinib), from SpringWorks Therapeutics, a kinase inhibitor, for adult and pediatric patients two years of age and older with ...
SpringWorks Therapeutics confirms FDA approval of Gomekli
SpringWorks Therapeutics (SWTX) announced that the U.S. FDA has approved Gomekli, SpringWorks’ MEK inhibitor, for the treatment of adult and ...
BioSpace9d
SpringWorks Wins FDA Nod for Neurofibromatosis Drug, Tees Up Challenge to AstraZeneca
The FDA on Tuesday signed off on SpringWorks Therapeutics’ mirdametinib—now to carry the brand name Gomekli—for the treatment ...
Pharm Exec9d
FDA Approves SpringWorks Therapeutics’ Gomekli for Neurofibromatosis Type 1, Symptomatic Plexiform Neurofibromas
Approval makes Gomekli the first treatment to be approved for both adults and pediatric patients for neurofibromatosis type 1, a genetic disorder that causes noncancerous tumors to grow on nerves ...
Morningstar10d
SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI was approved under Priority Review and SpringWorks received a rare pediatric disease priority review voucher from the FDA. GOMEKLI was previously granted Orphan Drug and Fast Track ...