The NeurologyLive FDA News page houses all of our coverage of FDA-related actions, from new drug approvals and advisory committee meetings to application submissions, clinical holds, trial clearances, and beyond.
Potential of Advancing Neurofibromatosis Care With Investigational Mirdametinib
September 4th 2024Jim Cassidy, MD, PhD, chief medical officer at SpringWorks Therapeutics, talked about how the prioritization of mirdametinib, a promising treatment for both adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas.
FDA Clears Clearmind Biomedical’s Neuroblade System for Minimally Invasive Neurosurgery
September 3rd 2024The system is composed of the Neuroblade, a single-use multifunctional neuroendoscope; the Neuropad, a reusable medical-grade tablet; and Clearpath, a disposable transparent access sheath.
FDA Grants Priority Review to New Drug Application of Neurofibromatosis Agent Mirdametinib
August 31st 2024Mirdametinib, a treatment in development for adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas, was granted a PDUFA target action date of February 28, 2025.
FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease
July 2nd 2024The approval of donanemab marks the third antiamyloid therapy to gain the FDA's greenlight, following the conditional approval of aducanumab in 2021, and lecanemab in 2023—although aducanumab no longer remains on market after it was removed earlier this year.
FDA Issues AbbVie Complete Response Letter for ABBV-951 in Parkinson Disease
Published: June 25th 2024 | Updated: June 25th 2024In the CRL, the agency cited observations identified during inspection of a third-party manufacturer listed in the NDA. If approved, ABBV-951 would be the first subcutaneous delivery option of carbidopa/levodopa.