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 Executive4h
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
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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 ...
C&EN2h
FDA approves drug for neurofibromatosis
The US Food and Drug Administration has approved mirdametinib for the treatment of neurofibromatosis type 1 (NF1) in adults ...
The American Journal of Managed Care2d
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 ...
The Pharma Letter2d
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 ...
Medscape4d
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 ...
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 ...
BioWorld2d
Springworks’ Gomekli wins priority FDA nod for NF1 neurofibromas
Snagging its second U.S. FDA approval since being spun out of Pfizer Inc. in 2017, Springworks Therapeutics Inc. is aiming to position Gomekli (mirdametinib), cleared for neurofibromatosis type ...
PMLiVE1d
FDA approves SpringWorks Therapeutics’ Gomekli to treat neurofibromatosis type 1
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat neurofibromatosis type 1 (NF1), a rare genetic disorder affecting approximately 100,000 ...