UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (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 ...
Managed Healthcare Executive1h
FDA Approves Gomekli, First and Only NF1-PN Treatment for Both Children and Adults
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult and pediatric patients.
GlobalData on MSN2d
FDA approves Gomekli as first neurofibromatosis drug for adults
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat ...
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 ...
Pharm Exec2d
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 ...
FiercePharma2d
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 ...
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 ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
Nasdaq2d
FDA Approves SpringWorks Therapeutics' GOMEKLI for Treatment of Neurofibromatosis Type 1 in Adults and Children
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 ...
pharmaphorum2d
With Merck circling, SpringWorks gets new drug approval
Stamford, Connecticut-based SpringWorks' Gomekli (mirdametinib) has become the first medicine approved for both adults and ...
SpringWorks shares rise on FDA nod for GOMEKLI
The FDA's green light for GOMEKLI is a significant achievement for SpringWorks, especially as it comes with a rare pediatric disease priority review voucher, which could be valued at around $100 ...
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 ...