FDA Action Update, December 2025: Approval, Designations, and Clinical Hold

Published Date: 09 Jan 2025

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.

Read Full News

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,...

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

Recommended News For You

Severe obesity associated with reduced prevalence of recommended cancer screenings

In 18 States, alcohol exclusion laws are still in effect.

New Nanoparticles Can Destroy Undruggable Cancer Proteins

After a plane crash, a surgeon dies; Austin is released from the hospital; and an animal pandemic spreads.

Two medications might work better for breast cancers that are resistant to one.

Is a $2,000 Whole-Body MRI Worth It?

Scientists are investigating the prevention of recurrent breast cancer, which frequently results in death.

Recommended Articles For You

Innovative Methods in Oncology in the Digital Era 

Artificial Intelligence for Early Cancer Detection Leveraging Multi-Omics: A Comprehensive Review 

AI in the War on Cancer: How Digital Tools are Revolutionizing Oncology 

Living Better With Advanced Cancer Through Supportive Care 

Whats more on Hidoc Dr.

Medical Updates
KOL Videos
Surveys
Events

Daily news to keep you up to date

Gain valuable insights with our in-depth KOL Video discussions

Participate and win cash vouchers

Get updates on the latest events happening around the world
Featured News
Featured Articles
Featured Events
Featured KOL Videos

1.

Next Day Mood Is Affected by Ability to Recover From Work.

2.

Enhanced CAR T cell therapy offers new strategy for lymphoma

3.

With the use of a novel sequencing technique, pediatric bone marrow transplant mortality can be predicted by analyzing lung microbiomes.

4.

Decrease seen in in situ breast cancer since 2009

5.

Scientists hail the cervical cancer treatment as the most remarkable breakthrough in 20 years.

1.

Discovering the Benefits of TNK: A Comprehensive Blog Article 

2.

Rare Malignant Ovarian Tumors: A Comprehensive Review for Clinicians

3.

Revolutionizing Cancer Treatment with Darzalex: How an Innovative Drug is Transforming Lives

4.

Personalized Cancer Vaccines: The Next Frontier in Precision Oncology

5.

Precision Medicine and Genomics: Revolutionizing Healthcare Through Personalized Treatment

1.

Asian Symposium on Advancement in Hematology and Oncology (ASAHO)

2.

International Cancer Conference

3.

Asian Symposium on Advancement in Hematology and Oncology (ASAHO)

4.

Asian Symposium on Advancement in Hematology and Oncology

5.

Asian Symposium on Advancement in Hematology and Oncology

1.

Influence of CDK4/6 Inhibitors in Extending Progression-Free Survival (PFS) and Overall Survival in HR+/HER2- mBC Patients

2.

Pazopanib: A Game-Changer in Managing Advanced Renal Cell Carcinoma - Part II

3.

Managing ALK+ NSCLC while Ensuring Long-Term Safety of the Patients

4.

Dissecting Molecular differences between EGFR Exon 19 deletion and Exon 21 L858R Mutations

5.

The Reign of the CROWN Trial and the Dawn of a New Era in Frontline Management- Further Discussion

Fastest Growing Medical Platform for Doctors

Address :
Hidoc Dr. Inc. | Delaware C Corp | 1309 Coffeen Ave. Suite 1200, Sheridan WY, 82801

Phone :
+1-415-463-3094

Email :
anishagadia@hidoc.co

Quick Links

Drug DatabaseDrug InteractionDiseases Database
KOL VideosKnowledge HubQuizzes
Medical UpdatesEventsAbout Us

© Copyright 2026 Hidoc Dr. Inc.

Terms & Conditions - LLP | Inc. | Privacy Policy - LLP | Inc. | Account Deactivation
Home
Profile
Login
bot