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 ...
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 molecule MEK inhibitor, ...
Pharmaceutical Technology7h
FDA approves Gomekli as first neurofibromatosis drug for adults
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat ...
Pharm Exec2h
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 ...
SpringWorks Therapeutics sets wholesale acquisition cost for GOMEKLI at $206.25
SpringWorks Therapeutics (SWTX) has announced that the U.S. Food and Drug Administration has approved GOMEKLI, a small molecule MEK inhibitor, ...
FiercePharma7h
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 ...
1SWTX : SpringWorks Therapeutics Secures FDA Approval For Second Cancer Drug
SpringWorks' Gomekli wins FDA approval for NF1-related tumors, showing strong efficacy in trials. U.S. launch expected in two ...
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 ...
BioSpace5h
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 ...
The Pharma Letter6h
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 ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
Spring Works shares rise on raised price target to $66
TD Cowen analysts increased their price target for Spring Works Therapeutics (NASDAQ:SWTX) shares to $66.00 from $63.00, while maintaining a "Buy" rating on the stock. The company's shares, currently ...