FDA Action Update, November 2024: Approvals, Clearance, and Clinical Hold

Published Date: 08 Dec 2024

Catch up on any of the neurology news headlines you may have missed over the course of November 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

Many Clinical Paths Are Open to NPs. Here’s Help in Picking

‘A strength of the nurse practitioner profession is its versatility,’ one expert says.

Nurses Speak Out on Burnout, Mandatory Overtime, and Burning the Candle at Both Ends

Emotionally drained, sleep-deprived, and skipping meals to keep up: what nurse leaders say needs to change to prevent burnout.

Most Family Physicians Struggle With After-Hours Admin Work

Most family physicians face heavy administrative burden, but improved electronic health records and staff support may help to ease some of the load.

'Just Bloating': Stop Dismissing This Common GI Complaint

Bloating is one of patients' most common gastrointestinal complaints. Dr Alicia Muratore kicks off this six-part series by asking why bloating is often treated as an afterthought.

S1 Episode 4: Urinary Tract Infections and Sexual Function

Drs Anne Lenore Ackerman and Rachel S. Rubin discuss urinary tract infections, sexual function, quality of life, and the importance of patient education.

Immunotherapy Promises New Era in Cancer Prevention

Prof David Kerr explores whether PD-1 inhibitors and targeted vaccines can regress polyps and prevent secondary cancers in Lynch syndrome.

HF Hospitalizations and Telehealth Coverage Parity Laws

State telehealth coverage parity laws require private insurers to cover outpatient telehealth visits increasing access for HF patients. This analysis examines whether this affected clinical outcomes.

Todays Updates

Many Clinical Paths Are Open to NPs. Here’s Help in Picking

‘A strength of the nurse practitioner profession is its versatility,’ one expert says.

Nurses Speak Out on Burnout, Mandatory Overtime, and Burning the Candle at Both Ends

Emotionally drained, sleep-deprived, and skipping meals to keep up: what nurse leaders say needs to change to prevent burnout.

Most Family Physicians Struggle With After-Hours Admin Work

Most family physicians face heavy administrative burden, but improved electronic health records and staff support may help to ease some of the load.

'Just Bloating': Stop Dismissing This Common GI Complaint

Bloating is one of patients' most common gastrointestinal complaints. Dr Alicia Muratore kicks off this six-part series by asking why bloating is often treated as an afterthought.

S1 Episode 4: Urinary Tract Infections and Sexual Function

Drs Anne Lenore Ackerman and Rachel S. Rubin discuss urinary tract infections, sexual function, quality of life, and the importance of patient education.

Immunotherapy Promises New Era in Cancer Prevention

Prof David Kerr explores whether PD-1 inhibitors and targeted vaccines can regress polyps and prevent secondary cancers in Lynch syndrome.

HF Hospitalizations and Telehealth Coverage Parity Laws

State telehealth coverage parity laws require private insurers to cover outpatient telehealth visits increasing access for HF patients. This analysis examines whether this affected clinical outcomes.

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,...

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.

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...

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

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Investigations may result in novel combination therapies for early-stage lung cancers.

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EU Adds CAR-T Warning; New Blincyto Indication; Good News in Pancreatic Cancer

Getting More Done With Less Blood.

Delaying Pegfilgrastim May Curb Bone Pain in Breast Cancer

Even after a partial ban, asbestos is still used and is a deadly carcinogen, according to the EPA.

A researcher has found that yoga exhibits the "most improvement" in helping long-term cancer survivors restore their brain health.

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