FDA Action Update, August 2024: Approvals, Designations, and Clearances

Published Date: 12 Sep 2024

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

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Latest News

APOE Epsilon 4 Flags ARIA Risk but Falls Short as Predictor

Real-world lecanemab findings show that APOE epsilon 4 status identifies patients at a higher risk for ARIA but cannot predict which individuals will develop the complication.

FDA Approves Brain-imaging Agent for Alzheimer's Assessment

The FDA has approved a radioactive agent for use ⁠in brain scans to help assess patients for Alzheimer's disease.

Neuromuscular Changes May Persist After Ligament Surgery

Patients who undergo anterior cruciate ligament reconstruction may show persistent neuromuscular alterations during functional tasks, despite reduced joint position sense errors.

Alzheimer Pathology Linked to Timely Dementia Diagnosis

Alzheimer disease and LATE-NC pathology were associated with more timely dementia diagnoses, a study shows.

Restricting Sugar in Early Life Tied to Lower Dementia Risk

Limiting sugar during pregnancy and infancy is associated with reduced risk for dementia during adulthood, delayed disease onset, and benefits for brain health, a study shows.

Ponesimod Safe, Effective Over 13 Years in RRMS

Ponesimod is well tolerated and effective for up to 13 years in patients with relapsing-remitting multiple sclerosis, a combined analysis shows.

Todays Updates

Hyponatremia Risk Varies Among Second-Gen Antipsychotics

Aripiprazole is associated with a lower risk for hyponatremia compared with olanzapine in patients treated with second-generation antipsychotics, a new cohort study shows.

HCT Survival Outcomes Improving in Relapsed Hodgkin Lymphoma

Researchers evaluate changes in post-transplantation outcomes among patients with relapsed or refractory Hodgkin lymphoma from 2010 to 2022.

How Much of a Cancer Drug Is Too Much?

In a recent KFF survey, 43% of US adults said they had skipped their medication in the past year because of cost.

Todays Updates

Hyponatremia Risk Varies Among Second-Gen Antipsychotics

Aripiprazole is associated with a lower risk for hyponatremia compared with olanzapine in patients treated with second-generation antipsychotics, a new cohort study shows.

HCT Survival Outcomes Improving in Relapsed Hodgkin Lymphoma

Researchers evaluate changes in post-transplantation outcomes among patients with relapsed or refractory Hodgkin lymphoma from 2010 to 2022.

How Much of a Cancer Drug Is Too Much?

In a recent KFF survey, 43% of US adults said they had skipped their medication in the past year because of cost.

Latest News

Real-world lecanemab findings show that APOE epsilon 4 status identifies patients at a higher risk for ARIA but cannot predict which individuals will develop the complication.

The FDA has approved a radioactive agent for use ⁠in brain scans to help assess patients for Alzheimer's disease.

Patients who undergo anterior cruciate ligament reconstruction may show persistent neuromuscular alterations during functional tasks, despite reduced joint position sense errors.

Alzheimer disease and LATE-NC pathology were associated with more timely dementia diagnoses, a study shows.

Limiting sugar during pregnancy and infancy is associated with reduced risk for dementia during adulthood, delayed disease onset, and benefits for brain health, a study shows.

Ponesimod is well tolerated and effective for up to 13 years in patients with relapsing-remitting multiple sclerosis, a combined analysis shows.

News All Time

Large Study Describes Genetic Underpinning of Fibromyalgia

‘This study provides important new insights into why some people develop fibromyalgia syndrome and identifies biological pathways that could lead to new treatment approaches,’ a study co-author says.

FDA Flags Data Concerns About Experimental DMD Therapy

U.S. FDA staff reviewers raised concerns about the effectiveness data for Capricor Therapeutics' cell therapy for a heart condition related ⁠to Duchenne muscular dystrophy,...

US FDA Approves Over-the-counter Tylenol Combination Pill for Pain Relief

The U.S. Food and Drug Administration on Friday approved a nonprescription, fixed-dose ⁠pill that combines Kenvue's Tylenol with the nonsteroidal anti-inflammatory drug...

Personalized Gene Therapy Promising in Rare Epilepsy

Individualized gene therapies reduce seizures and lead to developmental gains in two boys with severe, treatment-resistant SCN2A-related epilepsy.

Pollution Linked to French-British Oil Firm's Congo Operations Poses Health Risks, Report Says

Human Rights Watch said on Monday pollution linked to the operations of French-British oil firm Perenco in the Democratic ⁠Republic of Congo was exposing nearby communities...

Novel Neuromodulation Restores Movement After Paralysis

An experimental neuromodulation system enables a man with complete spinal cord injury to regain hand movement, sensation, and the ability to feed himself and grasp objects.

Mechanical Restraint in Psychiatric Care Tied to VTE Risk

Mechanical restraint is linked to a higher risk for venous thromboembolism than forced sedation in inpatients with psychiatric conditions, a new study shows.

TBI History Tied to False-Negative Alzheimer’s Blood Test

FDA-approved p-tau217/amyloid-beta-42 testing missed more amyloid PET-positive cases among older adults with prior TBI, a cross-sectional cohort study shows.

p-Tau217 May Predict Cognitive Decline Years Before Symptoms

Higher plasma p-tau217 levels identified cognitively sound older adults at greater risk for future cognitive impairment up to a decade before symptom onset.

ENTF Stim Boosts Freedom From Disability Post-Stroke

Electromagnetic stimulation combined with physical and occupational therapy is linked to a higher rate of freedom from disability post-stroke than sham, a study shows.

Rituximab Noninferior to Ocrelizumab in Relapsing MS

Rituximab is noninferior to ocrelizumab in suppressing disease activity in newly diagnosed multiple sclerosis, with a similar incidence of adverse events, a new trial shows.

FDA Neurology Roundup: June 2026

A monthly snapshot of FDA activity involving therapies for the prevention and treatment of neurologic diseases.

AI Uncovers ‘Invisible’ Cortical Lesions in MS MRI Scans

AI-enhanced analysis of conventional MRI scans reveals thousands of hidden cortical lesions in multiple sclerosis, potentially opening a new window into disease progression.

Deep Brain Stimulation Tied to Lower Mortality in PD

Deep brain stimulation is linked to reduced risks for mortality and institutionalization, and lower healthcare costs in adults with Parkinson’s disease, a study shows.

Ask the IIM Experts: From Immune Mechanisms to Emerging Therapies - A Comprehensive Update on Idiopathic Inflammatory Myopathies

Ask the IIM Experts: From Immune Mechanisms to Emerging Therapies - A Comprehensive Update on Idiopathic Inflammatory Myopathies

What Is Causing This Case of Sudden Aphasia?

Clues come from a kidney injury, encephalop­athy, and drug dosing error

Recommended News For You

Mobile prostate cancer screening clinic can ID the disease in disadvantaged men

A three-quarters reduction in the risk of prostate cancer is associated with an annual increase in cardiorespiratory fitness of more than three percent.

Vepdegestrant Earns FDA Nod for ESR1-Mutated Breast Cancer

New study elucidates obesity's role in fueling breast cancer progression

Improved end-of-life conversations for cancer patients are identified by a new study.

Adaptive SABR-Used Hypofractionated Chemoradiation Showed Good Results in NSCLC.

Datopotamab Deruxtecan Earns New Breast Cancer Indication

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