FDA, GOMEKLI

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 from Phase 2b ReNeu
FDA approves Gomekli as first neurofibromatosis drug for adults
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat neurofibromatosis type 1 (NF1), a type of rare genetic disorder. Both adult and paediatric patients with NF1 who have symptomatic plexiform neurofibromas (PN) that cannot be surgically removed will be eligible for the treatment.
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 throughout the body.
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 1-associated plexiform neurofibromas (NF1-PN) not amenable to complete resection,
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 disorder neurofibromatosis type 1 (NF1), a rare genetic condition.
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 neurofibromatosis type 1 (NF1) – a type of tumor that forms on nerves,
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 nerves throughout the body.  The federal agency said on Tuesday it
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
SpringWorks shares rise on FDA nod for GOMEKLI
Shares of SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) climbed 2.7%, building on a previous gain of 2%, following the FDA approval of their drug, GOMEKLI, for the treatment of neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
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, ...
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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 ...
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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 ...
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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 ...
SpringWorks COO Edris Badreddin sells $1.59 million in stock
Edris Badreddin, Chief Operating Officer of SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), sold 30,000 shares of the company's ...