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 ...
Healio1d
FDA approves Gomekli for neurofibromatosis type 1 with plexiform neurofibromas
The FDA has approved an oral, small molecule MEK inhibitor for adult and pediatric patients 2 years of age and older with ...
FiercePharma6d
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 ...
GlobalData on MSN6d
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 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 ...
Onco360 Has Been Selected as a National Specialty Pharmacy Partner for GOMEKLI™ (mirdametinib), Manufactured By SpringWorks Therapeutics
Onco360 ®, the nation’s leading independent specialty pharmacy, has been selected as a national pharmacy partner by SpringWorks Therapeutics, Inc. for GOMEKLI (mirdametinib). The Food & Drug ...
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 ...
pharmaphorum6d
With Merck circling, SpringWorks gets new drug approval
Stamford, Connecticut-based SpringWorks' Gomekli (mirdametinib) has become the first medicine approved for both adults and ...
Managed Healthcare Executive4d
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 ...
BioSpace6d
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 ...
Yahoo Finance5d
SpringWorks sets wholesale acquisition cost for Gomekli at $206.25 per mg
SpringWorks has set a wholesale acquisition cost for Gomekli at $206.25 per mg. The company estimates that the average cost of treatment will be approximately $22,000 per month for pediatric ...