2 days ago · STAMFORD, Conn., Feb. 11, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved GOMEKLI™ (mirdametinib), SpringWorks’ MEK inhibitor, for the treatment of ...

1 day ago · STAMFORD, Conn., Feb. 11, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved GOMEKLI™ (mirdametinib), SpringWorks’ MEK inhibitor, for the treatment of ...

1 day ago · GOMEKLI™ (mirdametinib) capsules and tablets for oral suspension GOMEKLI™ (mirdametinib) capsules and tablets for oral suspension Saqib Islam, SpringWorks Therapeutics CEO Saqib Islam ...

1 day ago · GOMEKLI. Prescribing Information. SpringWorks Therapeutics, Inc. Prada C, Rangwala F, Martin L, et al. Pediatric Plexiform Neurofibromas: Impact on Morbidity and Mortality in Neurofibromatosis Type 1.

10 hours ago · SpringWorks’ Gomekli is an oral small molecule MEK inhibitor and the first and only FDA-approved therapy for both adults and children with NF1-PN. The FDA’s decision on the drug was supported by results from the phased 2b ReNeu trial, which demonstrated an objective response rate of 41% and 52% in adult and paediatric NF1-PN patients ...

2 days ago · SpringWorks Therapeutics has announced the FDA approval of GOMEKLI (mirdametinib), the first medication for both adults and children aged 2 and older with neurofibromatosis type 1 (NF1) associated ...

1 day ago · The FDA has approved SpringWorks Therapeutics’ Gomekli (mirdametinib), an MEK inhibitor, for the treatment of adult and pediatric patients over two years of age with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas (PN) not amenable to complete resection. According to the company, the approval marks the first treatment ...

1 day ago · SpringWorks Therapeutics’ Gomekli is now FDA approved for treating tumors caused by the rare genetic disorder neurofibromatosis type 1. The approval comes as SpringWorks has emerged as a ...

SpringWorks Therapeutics Inc (SWTX, Financial), a biopharmaceutical company focused on severe rare diseases and cancer, announced on February 11, 2025, that the U.S. Food and Drug Administration (FDA) has approved GOMEKLI™ (mirdametinib).This MEK inhibitor is now the first and only approved treatment for both adults and children aged 2 years and older with neurofibromatosis type 1 (NF1) who ...

1 day ago · Gomekli’s approval was backed by a phase 2b trial in which it achieved a 52% response rate in pediatric patients and a 41% response rate in adults. The trial enrolled 58 adult and 56 pediatric ...