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FDA Grants Priority Review to New Drug Application of …
WEB5 days ago · According to a new announcement, the FDA has accepted and granted priority review to SpringWorks Therapeutics’ new drug application (NDA) for mirdametinib, an …
FDA Grants Priority Review to SpringWorks Therapeutics’ New …
WEBNeurofibromatosis type 1 (NF1) is a rare genetic disorder that arises from loss-of-function variants in the NF1 gene, which encodes for neurofibromin, a key suppressor of the …
FDA grants Priority Review to NDA for mirdametinib for the …
WEB3 days ago · SpringWorks Therapeutics, Inc. announced that the FDA has accepted the Company’s New Drug Application (NDA) for mirdametinib, an investigational MEK …
FDA Grants Priority Review To SpringWorks Therapeutics’ New …
WEBSTAMFORD, Conn., August 28, 2024 – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and …
FDA Approves First Ever Treatment for …
WEBApr 10, 2020 · Koselugo (selumetinib) is the first approved drug for NF1 patients with inoperable plexiform neurofibromas, a type of tumor that grows on nerves. The approval is based on clinical trials funded by CTF and …
Study demonstrates efficacy of new treatment for …
WEBJan 14, 2021 · Cabozantinib, a tyrosine kinase inhibitor, reduces tumor volume and pain in patients with neurofibromatosis type 1 (NF1), a genetic disorder that causes nerve …
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FDA approves selumetinib for neurofibromatosis type 1 with …
WEBOn April 10, 2020, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca) for pediatric patients, 2 years of age and older, with neurofibromatosis …
Selumetinib in Children with Inoperable Plexiform …
WEBMar 18, 2020 · Children with neurofibromatosis type 1 and symptomatic inoperable plexiform neurofibromas received oral selumetinib twice daily at a dose of 25 mg per square meter of body-surface area on a...
Selumetinib Approved by FDA to Treat Children with NF1
WEBApr 14, 2020 · The Food and Drug Administration (FDA) has approved selumetinib (Koselugo) to treat children with neurofibromatosis 1 (NF1), a genetic disorder that causes tumors, called plexiform neurofibromas, to …
FDA grants orphan drug status to selumetinib for …
WEBApr 23, 2018 · The U.S. Food and Drug Administration granted orphan drug status in February to selumetinib for use in patients with the genetic disorder neurofibromatosis type 1 (NF1), who often develop tumors of …
Breakthrough in Neurofibromatosis Type 1 Treatment: …
WEBThe recent trial by SpringWorks Therapeutics introduces mirdametinib as a potential game-changer in the treatment of NF1-associated plexiform neurofibromas. Unlike traditional approaches that address the …
FDA Approval Sought for Mirdametinib in NF1-PN - OncLive
WEBMar 4, 2024 · In July 2023, the FDA granted mirdametinib rare pediatric disease designation for the treatment of NF1, which provides eligibility for a priority review …
First drug approved for neurofibromas is a MEK inhibitor
WEBMay 11, 2020 · AstraZeneca found a winning indication for Koselugo (selumetinib), the first drug to be approved by the US Food and Drug Administration (FDA) for …
A New Treatment for Children With Neurofibromatosis Type 1
WEBSelumetinib is the first drug approved for pediatric patients aged 2 years or older with neurofibromatosis type 1 (NF1), a rare disfiguring disease. Marketed as Koselugo, the …
Neurofibromatosis type 1 - Diagnosis and treatment - Mayo Clinic
WEBJun 1, 2024 · Early diagnosis and treatment are the most important factors for a good outcome. Potential future treatments. Researchers are testing gene therapies for …
Advances in NF1-PN treatment - Medical News Today
WEBJun 17, 2024 · After more than 30 years of research aimed at finding a treatment for NF1-PN, selumetinib — a twice-daily oral medication — became the first treatment option …
Activity of Selumetinib in Neurofibromatosis Type 1–Related …
WEBDec 29, 2016 · Effective medical therapies are lacking for the treatment of neurofibromatosis type 1–related plexiform neurofibromas, which are characterized by …
Finding May Lead to New Treatments for Neurofibromatosis
WEBNov 20, 2020 · Common symptoms of the genetic disorder neurofibromatosis type 1 (NF1), including skeletal fragility and the loss of bone mass, may be treatable with an …
Advanced pharmacological therapies for neurofibromatosis type 1 …
WEBJun 30, 2020 · Among new emerging drugs, Selumetinib has shown promising results in the treatment of NF1-associated OPG. Selumetinib is an oral selective inhibitor of MEK 1 …
New Research Offers More Options to People with …
WEBAdvances in treatment and new approaches to gene therapy are generating much hope in the NF1 community, Dr. Plotkin says. “There is so much exciting research in progress …
Clinical trial evaluates drug for treatment of neurofibromatosis …
WEBFeb 17, 2022 · Over time, PNs may transform into atypical neurofibromas (ANFs) and then into cancerous tumors. Andrea Gross, M.D., Assistant Research Physician in the …
Strong Buy Rating for Springworks Therapeutics as Mirdametinib …
WEB2 days ago · Corinne Johnson has given her Buy rating due to a combination of factors surrounding Springworks Therapeutics’ promising treatment, mirdametinib, for …
FDA approves first ever treatment for neurofibromatosis - Medical …
WEBApr 13, 2020 · The U.S. Food and Drug Administration (FDA) has approved Koselugo (selumetinib) for use in patients with inoperable plexiform neurofibromas, a common …
Neurofibromatosis type 1: New developments in genetics and …
WEBNew therapeutic and preventive options include tyrosine kinase inhibitors, mTOR inhibitors, interferons, and radiofrequency therapy. This review summarizes recent …
Neurofibromatosis Type 1 (NF1) - Johns Hopkins Medicine
WEBWhile there is no treatment that can reverse NF1, its signs and symptoms can be addressed. Tumors, in particular, may warrant chemotherapy, radiation, surgery or a …
Emerging therapeutic targets for neurofibromatosis type 1 (NF1)
WEBIn addition, several recent studies have highlighted the potential of targeting the immune system for NF1 treatment. NF1−/+ mast cells play a key role in both tumorigenesis and …
New experimental treatment can stop the growth of schwannoma …
WEBNov 8, 2022 · Researchers from University of Plymouth found that two experimental drugs can block the Hippo signalling pathway and reduce the growth of schwannoma and …
NF1 Associated with More Cancer Types Than Previously Known
WEBApr 20, 2021 · People with neurofibromatosis type 1 (NF1) develop more types of cancer than previously recognized, according to a new study. They also developed some …
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