Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...

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 ...

GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...

The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat ...

As SpringWorks Therapeutics nears a key regulatory decision in the U.S., the Connecticut-based cancer and rare disease ...

Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respec ...

The FDA has approved an oral, small molecule MEK inhibitor for adult and pediatric patients 2 years of age and older with ...

The kinase inhibitor is now approved for adults and children aged ≥ 2 years with neurofibromatosis type 1 who have ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA on Tuesday approved mirdametinib (Gomekli) for adults and kids ages 2 and up with neurofibromatosis type 1 (NF1).

SpringWorks’ Marketing Authorization Application for mirdametinib for the treatment of children and adults with NF1-PN was validated by the European Medicines Agency (EMA) and is currently under ...