Neurology
Page 1 • 12 itemsGain critical insights into global neurology drug development, clinical trials, regulatory approvals, and market trends. Inform your pharma strategy.
Clene Receives FDA Green Light for CNM-Au8 Accelerated Approval Pathway in ALS Treatment
Clene advances CNM-Au8 for ALS treatment after FDA confirms accelerated approval pathway eligibility based on neurofilament light biomarker data.
InspireMD Receives FDA Approval for SwitchGuard Neuro Protection System CGUARDIANS III Pivotal Trial
InspireMD secures FDA IDE approval for CGUARDIANS III pivotal study of SwitchGuard Neuro Protection System, advancing stroke prevention technology development.
Clene's CNM-Au8 Gets FDA Green Light for Accelerated Approval Pathway in ALS Treatment
FDA confirms Clene's CNM-Au8 ALS drug can proceed via accelerated approval pathway using neurofilament light biomarker data, with NDA filing expected Q3 2026.
Novartis Receives Health Canada Approval for Fabhalta Oral Treatment for C3G Patients
Health Canada approves Novartis' Fabhalta (iptacopan) oral treatment for adults with complement 3 glomerulopathy, offering new hope for rare kidney disease patients.
Akebia Therapeutics Vadadustat Shows Significant Mortality Reduction in New Kidney Disease Analysis
Akebia Therapeutics announces Vadadustat post-hoc analysis published in JASN shows statistically significant reduction in mortality and hospitalization for kidney disease patients.
Spinogenix Tazbentetol Shows Neuroprotective Effects in Glaucoma and Diabetic Retinopathy Preclinical Studies at ARVO 2026
Spinogenix presents preclinical data showing Tazbentetol (SPG302) reduces retinal cell loss and preserves visual function in eye disease models at ARVO 2026.
Axsome FDA Approval for Alzheimer's Agitation Drug
Axsome Therapeutics has received FDA approval for a new treatment for agitation associated with Alzheimer's disease. This landmark decision addresses a critical unmet need and marks a significant step forward for the company and Alzheimer's patient care.
Rhythm Pharmaceuticals' IMCIVREE Receives European Commission Approval for Acquired Hypothalamic Obesity
IMCIVREE becomes first therapy approved in both US and Europe for acquired hypothalamic obesity, targeting adults and children 4+ with hypothalamic injury.
Vanda Pharmaceuticals Launches NEREUS (Tradipitant) - First New Motion Sickness Drug in 40+ Years Now Available
Vanda Pharmaceuticals' NEREUS (tradipitant) is now commercially available in the US, marking the first new prescription motion sickness treatment in over 40 years.
ZETA SURGICAL Receives FDA 510(k) Clearance for Brain Surgery Navigation System
ZETA SURGICAL's Zeta Navigation System receives FDA 510(k) clearance for brain tumor biopsies, hydrocephalus treatment, and trigeminal neuralgia procedures.
Axsome Therapeutics Receives FDA Approval for AUVELITY to Treat Alzheimer's Agitation - First-in-Class Breakthrough
Axsome Therapeutics announces FDA approval of AUVELITY for Alzheimer's agitation, marking first-in-class treatment for critical unmet medical need.
AC Immune Advances ACI-24 Alzheimer's Trial to Final Cohort, Initiates ACI-19764 Phase 1 Study
AC Immune progresses ACI-24 Alzheimer's treatment to final trial phase while starting new brain-penetrant NLRP3 inhibitor study in Q1 2026 update.