Rare disease news

FDA approvals, research breakthroughs, clinical trials, and advocacy updates

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462 articles from the last 90 days

Clinical trialUNITERAREApr 15

New Recruiting Trial: 18F-mFBG Cardiac Uptake With Lewy Body Dementia

Researchers are testing a new imaging scan called 18F-mFBG that can take pictures of the heart in people with Lewy body dementia, a brain disease that causes movement problems and thinking difficulties. This Phase 2 trial is now accepting patients and aims to see if this special scan can help doctors better understand and diagnose the disease. The scan uses a safe radioactive tracer that shows how well the heart's nerve endings are working.

WHY IT MATTERSThis trial is now actively recruiting patients with Lewy body dementia — if you have this diagnosis, you may be eligible to participate in a study that could help develop better diagnostic tools for your condition.
You can act on thisLewy body dementiaRead →
Clinical trialUNITERAREApr 15

New Recruiting Trial: Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma

Researchers are looking for patients with a specific type of blood cancer called Philadelphia chromosome positive acute lymphoblastic leukemia to test a new treatment combination. The treatment uses chemotherapy drugs (EPOCH), sometimes combined with rituximab (a protein therapy), plus a targeted drug called ponatinib. This is a Phase 2 trial, meaning it's testing whether the treatment works and is safe in a larger group of patients.

WHY IT MATTERSThis trial is now actively recruiting patients with newly-diagnosed Ph+ ALL/lymphoma and offers access to ponatinib, a third-generation tyrosine kinase inhibitor that may improve outcomes for this aggressive blood cancer.
You can act on thisPhiladelphia chromosome positive acute lymphoblastic leukemiaPhiladelphia chromosome positive lymphomaRead →
Clinical trialUNITERAREApr 15

New Recruiting Trial: Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas

Researchers are testing a new cancer treatment that combines two approaches: a chemotherapy drug called temozolomide and a vaccine called SurVaxM that trains the immune system to fight cancer cells. This trial is for patients with neuroendocrine carcinomas (rare cancers in hormone-producing cells) that are spreading and getting worse despite other treatments. The study is now accepting patients and will run through 2026.

WHY IT MATTERSThis is one of the first trials testing an immunotherapy vaccine specifically for metastatic neuroendocrine carcinomas, offering a potential new option for patients whose cancer has progressed on standard treatments.
You can act on thisneuroendocrine carcinomametastatic neuroendocrine carcinomaRead →
PolicyRSSApr 14

FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development

The FDA released new guidelines to help companies develop gene therapy treatments that use genome editing—a technology that can fix or change faulty genes. These guidelines explain what safety information and testing companies need to provide before the FDA will approve their treatments. This is meant to make it clearer and faster for companies to develop new gene therapies for patients with genetic diseases.

WHY IT MATTERSThis guidance establishes the regulatory pathway that will determine which genome editing therapies can reach patients, potentially accelerating approval timelines for rare genetic diseases currently lacking treatment options.
Good to knowRead →
Clinical trialCLINICALTRIALSApr 14

Trial Now Recruiting: Evaluation of Socio-professional Inclusion for Young Adults Aged 15-25 Living With a Rare Genetic Disability (NCT07527624)

Researchers are looking for young adults ages 15-25 with rare genetic disabilities to join a study about getting jobs and education. The study will follow 300 participants and examine the challenges these young people face when trying to go to school, get internships, or find work. Many young people with rare genetic diseases struggle with these opportunities because of their condition and lack of support.

WHY IT MATTERSThis trial directly addresses employment and education barriers that young adults with rare genetic disabilities face — areas where they typically have the fewest resources and support.
You can act on thisRead →
Clinical trialCLINICALTRIALSApr 14

Trial Results Posted: Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR) (NCT04046224)

Researchers tested a new gene therapy called ST-920 for Fabry disease in 36 patients. This treatment uses a modified virus to deliver instructions that help the body make an enzyme called alpha-galactosidase A, which people with Fabry disease don't produce enough of. The trial is now complete and tested whether different doses were safe and well-tolerated.

WHY IT MATTERSThis completed Phase 1/2 trial is the first human test of ST-920, meaning results could help determine if gene therapy can provide long-term relief for Fabry disease patients who currently require lifelong enzyme replacement infusions.
💬 Ask your doctorFabry diseaseRead →
ResearchPUBMEDApr 14

Characterisation of Urine-Derived Cells for the Molecular Diagnosis of Rare Disorders.

Scientists discovered that cells found in urine can be grown in the lab and used to diagnose genetic diseases. These urine cells come from a specific part of the kidney called the glomerulus, and they have special properties that make them useful for testing. This method could make genetic diagnosis easier because urine is simple to collect compared to other tissue samples.

WHY IT MATTERSIf your child needs genetic testing for a rare disorder, this research suggests urine samples could eventually replace more invasive procedures like blood draws or biopsies for molecular diagnosis.
Good to knowRead →
ResearchPUBMEDApr 14

Rare genetic diseases associated with G-quadruplex-induced replication stress.

Scientists have discovered that certain rare genetic diseases are caused by mutations in genes that help cells copy their DNA. These genes normally produce proteins that untangle special twisted DNA structures called G-quadruplexes that get in the way during copying. When these proteins don't work properly, cells can't copy their DNA correctly, leading to problems like weak immune systems, slow growth, birth defects, and increased cancer risk.

WHY IT MATTERSUnderstanding which genes cause these G-quadruplex problems could help doctors diagnose patients with unexplained immunodeficiency, growth delays, or birth defects, and may eventually lead to targeted treatments for these currently untreatable conditions.
Good to knowRead →
ResearchBIORXIVApr 14

Preprint: CoNVict: An Agentic AI System for Copy Number Variation Prioritization in Rare Disease Diagnosis

Scientists created a new AI system called CoNVict that helps doctors figure out which genetic changes are actually causing rare diseases. Copy number variants (CNVs) are sections of DNA that are duplicated or missing, and they can cause genetic disorders, but it's hard to know which ones matter. This new tool uses artificial intelligence to automatically score and rank these genetic changes so doctors can focus on the ones most likely to be causing a patient's symptoms.

WHY IT MATTERSIf your child has unexplained developmental delays or birth defects and genetic testing found copy number variants, this AI tool could help doctors identify which variant is actually responsible for your child's condition, potentially speeding up diagnosis.
👁 Watch this spaceRead →
ResearchBIORXIVApr 14

Preprint: The Economic Burden of KCNT1-Related Disorders in the United States: Insights from Caregiver-Reported and EMR-Derived Data

Researchers studied how much money families and the healthcare system spend on KCNT1-related disorders, a rare genetic brain condition that causes severe seizures starting in early childhood. The study used information from both families caring for patients and medical records to understand the true financial costs. This is important because there are currently no approved treatments that can change the course of the disease, so families face lifelong expensive care.

WHY IT MATTERSIf you have a child with KCNT1-related epilepsy, this research documents the financial burden your family faces and provides evidence that could support insurance coverage decisions and funding for new treatments.
Good to knowKCNT1-related epilepsyKCNT1-related disordersRead →
ResearchCLINICALTRIALSApr 14

Trial Completed: Using Social Robots in Children With Rare Diseases and Their Parents: A Feasibility Study (NCT06466109)

Researchers completed a small study with 14 children who have rare diseases and their parents to test whether a social robot could help families cope better. The robot was designed to provide support and improve relationships between parents and children while reducing stress and worry. The study looked at whether families found the robot helpful and acceptable to use in their daily lives.

WHY IT MATTERSThis completed trial demonstrates a novel approach to family-centered support for rare disease patients—social robots may offer accessible emotional and relational support when specialized mental health resources for rare disease families are limited.
Good to knowRead →
Clinical trialCLINICALTRIALSApr 14

Trial Now Recruiting: Monogenic Kidney Stone - Genetic Testing (NCT03305835)

Researchers at Mayo Clinic are looking for 6,000 people with rare kidney stone diseases caused by a single gene mutation to join a study. The study will identify which specific genes and genetic changes cause these kidney stones. By understanding the genetics behind these stones, scientists hope to develop better treatments in the future.

WHY IT MATTERSIf you have a rare monogenic kidney stone disease, this trial could help identify the genetic cause of your condition and accelerate development of targeted treatments — and you can enroll now.
You can act on thisMonogenic kidney stone diseasePrimary hyperoxaluriaDent diseaseRead →
Clinical trialCLINICALTRIALSApr 14

Trial Now Recruiting: A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years of Age With a Rare Disease Called CHAPLE (Complement Hyperactivation, Angiopathic Thrombosis, Protein-losing Enteropathy) Disease (NCT07142343)

Researchers are testing a new medicine called pozelimab in young children ages 1 to 5 who have CHAPLE disease, a rare inherited condition that affects the stomach, intestines, heart, and blood vessels. This study is checking whether the medicine is safe and well-tolerated in this young age group. CHAPLE disease can cause serious symptoms, so finding safe treatments for young children is important.

WHY IT MATTERSThis is the first safety trial of pozelimab in very young children (ages 1-5) with CHAPLE disease, offering families of affected toddlers a potential treatment option when few alternatives exist for this life-threatening condition.
You can act on thisCHAPLE diseaseRead →
Clinical trialCLINICALTRIALSApr 14

Trial Now Recruiting: Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK) (NCT07524114)

Researchers are recruiting 7,000 cancer patients to test a new way of detecting cancer that comes back after treatment. By analyzing blood, tissue, and other body fluids for traces of cancer DNA, doctors hope to catch cancer earlier and help patients stay cancer-free longer. This study includes many types of cancer and will help doctors decide on the best treatment plans.

WHY IT MATTERSThis trial is now actively recruiting patients with various cancer types at a major Canadian cancer center, offering access to cutting-edge molecular residual disease testing that could detect cancer recurrence months before traditional imaging scans.
You can act on thisBreast CancerLung CancerMelanomaRead →
PolicyRSSApr 13

FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results

The FDA sent reminders to over 2,200 companies and research groups telling them they must share their clinical trial results on a public website called ClinicalTrials.gov. This is a requirement, not optional. The FDA is making sure that information about how medical treatments work—whether they help patients or cause problems—gets shared publicly so everyone can see the results.

WHY IT MATTERSWhen companies hide negative trial results, patients may not know the full picture about whether a treatment actually works, which could affect decisions about whether to participate in a trial or use a medication.
Good to knowRead →
ResearchPUBMEDApr 13

Rare and uncommon tumours of the female pelvis: what the radiologist should know.

This article helps doctors who read medical images understand rare tumors that grow in women's reproductive organs. These tumors are uncommon, affecting fewer than 6 out of every 100,000 people each year, which makes them hard to diagnose and treat. The article explains what these tumors look like on imaging scans and how doctors can better identify them to help plan treatment.

WHY IT MATTERSIf you have been diagnosed with an uncommon gynecological tumor, radiologists who understand these rare conditions are better equipped to provide accurate imaging reports that guide your treatment decisions.
Good to knowRead →
ResearchBIORXIVApr 13

Preprint: WITHDRAWN: Parents' Experiences of Navigating Diagnostic Uncertainty in Children With Rare Diseases: A Narrative Inquiry

A research study about how parents cope when their children have rare diseases and doctors can't quickly figure out what's wrong was withdrawn from a scientific website. The authors submitted the study with false information, so it is no longer available for other researchers to read or use.

WHY IT MATTERSThis withdrawal highlights the importance of verifying research quality and integrity — families relying on studies about rare disease diagnosis need accurate, trustworthy information to guide their own experiences.
Good to knowRead →
ResearchBIORXIVApr 12

Preprint: Complementary vertebrate Wac models exhibit phenotypes relevant to DeSanto-Shinawi Syndrome

Scientists created animal models (using fish and mice) that mimic DeSanto-Shinawi Syndrome, a rare genetic disorder caused by mutations in the WAC gene. These animal models showed symptoms similar to what patients experience, including developmental delays, intellectual disability, autism-like behaviors, and seizures. This research helps scientists understand how WAC gene mutations cause these symptoms and could lead to better treatments in the future.

WHY IT MATTERSFor the first time, researchers have created animal models that reproduce the key symptoms of DeSanto-Shinawi Syndrome, which could accelerate the discovery of why patients develop autism, seizures, and developmental delays—and potentially identify new treatment targets.
👁 Watch this spaceDeSanto-Shinawi SyndromeRead →
ResearchPUBMEDApr 12

A comprehensive approach to evaluating the clinical utility of genome sequencing in rare disease: A large prospective Canadian cohort.

Researchers in Canada studied 715 patients with rare diseases who had their entire genome sequenced (a test that reads all of a person's genetic code). The study found that genome sequencing helped doctors in many ways: it confirmed diagnoses in some patients, changed how doctors treated 36% of patients, found new research opportunities, and identified genetic information that relatives should know about. The test also helped doctors avoid unnecessary tests in 88% of cases.

WHY IT MATTERSIf you have an undiagnosed rare disease, this research shows that whole genome sequencing can help your doctor find answers and change your treatment plan — and it may also reveal important genetic information for your family members.
💬 Ask your doctorRead →
ResearchPUBMEDApr 11

Scaling genomic reanalysis to unlock diagnoses and transform rare disease care.

Researchers at Boston Children's Hospital created a new system that automatically re-examines genetic test results from patients with rare diseases as doctors learn more about genes and diseases. Many patients get genetic tests but don't get answers the first time. This new system helps find answers by looking at old test results again without waiting for doctors to manually review each one.

WHY IT MATTERSIf you or your child had genetic testing that didn't find a diagnosis, this system could identify the cause of your rare disease by re-analyzing your existing test results as medical knowledge improves—potentially saving you years of diagnostic searching.
Good to knowRead →
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