FDA News

Earlier this year, IDP-023 received fast track designation by the FDA for the treatment of patients with multiple myeloma and non-Hodgkin lymphoma.

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

Marketed as Zunveyl for mild-to-moderate Alzheimer disease, ALPHA-1062 is considered a new-generation acetylcholinesterase inhibitor with expected minimal gastrointestinal adverse events.

The application was supported by positive data of KYV-101 in patients with stiff-person syndrome treated in Germany under a named-patient treatment option.

The expanded indication, supported by a phase 2 open-label trial, includes children of all ages with CLN2 disease, regardless of whether they are symptomatic or asymptomatic.

Tiziana Life Sciences’ intranasal foralumab has shown potential in treating nonactive secondary progressive multiple sclerosis through innovative immune modulation.

With the approved IND, it expands research efforts of equecabtagene autoleucel from other autoimmune conditions like myasthenia gravis and NMOSD.

Pending positive results from an early-stage trial, a mid-stage study evaluating MyoPAXon’s effect on other targeted muscles and muscle function will be initiated.

The investigational therapy, which targets neurodegeneration, has shown promise in phase 2 and 3 studies of Alzheimer disease and Parkinson disease, with additional studies on the way.

Lomecel-B is made from living cells called medicinal signaling cells that are isolated from fresh bone marrow tissue that has been donated by adult donors aged 18 to 45.

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Sameea Husain-Wilson, DO. [LISTEN TIME: 19 minutes]

Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with Joel Salinas, MD, MBA. [LISTEN TIME: 10 minutes]

Overall, treated patients showed improvements in multiple cardiac measures, including left ventricular ejection fraction, as well as indexed volumes.

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

The 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.

In 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.

Pitolisant is the first and only drug in the class of antagonist/reverse agonists of the histamine H3 receptor for the treatment of patients with narcolepsy.

The therapy is the first and only neonatal Fc receptor blocker approved for the treatment of CIDP, and will be available as a once-weekly, 30- to 90-second subcutaneous injection.

The AAV vector-based gene therapy originally received FDA approval for treating ambulatory pediatric patients aged 4 to 5 years with Duchenne under the accelerated approval pathway.

The cleared phase 1/2 clinical trial will assess SPG302 as a once-a-day pill among patients with amyotrophic lateral sclerosis.

AMT-130, uniQure’s investigational gene therapy, is the first therapeutic candidate to receive regenerative medicine advanced therapy designation for Huntington disease.

Deflazacort, a corticosteroid approved for children with Duchenne muscular dystrophy, has been on the market since 2017 under the name Emflaza.

In a pivotal, large-scale, phase 3 trial, donanemab met its primary end point, demonstrating more pronounced effects in patients with early-stage Alzheimer disease who had low/medium tau status.

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

If the sBLA is approved, the clinical and biomarker benefits may be maintained through the once-monthly dosing regimen that is less burdensome and easier for patients and care partners to continue long-term.

Following presented phase 1 clinical trial findings at AAN 2024, bemdaneprocel receives regenerative medicine advanced therapy designation by the FDA for the treatment of Parkinson disease.

The headset features soft-tip electrodes, artificial intelligence-enabled notifications, and cloud integration for remote monitoring of EEG in clinical practice.

The FDA approval of the increased maximum daily dose for amifampridine offers clinicians and patients greater flexibility in treatment regimens for the management of Lambert-Eaton myasthenic syndrome.

The newly added tablet strengths allow for greater flexibility when selecting or adjusting dosing for deutetrabenazine.

Larimar Therapeutics anticipates interim data from the open label extension study assessing nomlabofusp in patients with Friedreich Ataxia in the fourth quarter of 2024.