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 ...
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 ...
The American Journal of Managed Care3h
FDA Approves Mirdametinib for Neurofibromatosis Type 1 with Plexiform Neurofibromas
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
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 ...
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 Letter7h
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 ...
pharmaphorum5h
With Merck circling, SpringWorks gets new drug approval
Stamford, Connecticut-based SpringWorks' Gomekli (mirdametinib) has become the first medicine approved for both adults and children with plexiform neurofibromas (PN) in patients with the genetic ...
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 ...
FDA approves SpringWorks’ mirdametinib for adult and pediatric NF1 patients
The Food and Drug Administration approved mirdametinib, brand name Gomekli, from SpringWorks Therapeutics (SWTX), a kinase inhibitor, for adult ...
Medscape1d
FDA Approves Mirdametinib for Neurofibromatosis Type 1
The kinase inhibitor is now approved for adults and children aged ≥ 2 years with neurofibromatosis type 1 who have unresectable symptomatic plexiform neurofibromas.