FDA News

Takeda's FDA-approved Gammagard Liquid can be used as induction therapy, which includes an induction dose followed by maintenance doses, for adults with chronic inflammatory demyelinating polyneuropathy.

The dihydroergotamine product’s application was supported by phase 1 comparative pharmacokinetic and safety data, and the phase 3 ASCEND trial.

Aruna Bio's investigational treatment, AB126, is now set for a phase 1b/2a clinical trial targeting acute ischemic stroke, anticipated to begin in the first half of 2024.

Takeda's Hyqvia is the only FDA-approved combination of immunoglobulin and hyaluronidase, which makes it a facilitated subcutaneous immunoglobulin infusion, for patients with chronic inflammatory demyelinating polyneuropathy.

The newly FDA-approved AI-powered software platform BrainSee utilizes brain MRI and cognitive assessments to reportedly predict the progression of amnestic mild cognitive impairment to Alzheimer disease in 5 years.

Catch up on any of the neurology news headlines you may have missed over the course of January 2024, compiled all into one place by the NeurologyLive® team.

Months after the FDA cleared a phase 2 study in myasthenia gravis, KYV-101 is set to be assessed in a diverse cohort of refractory progressive multiple sclerosis.