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

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474 articles from the last 90 days

ResearchBIORXIVApr 6

Preprint: Patient and family reported clinical picture of IRF2BPL-related disorders

Researchers studied a rare genetic disorder called IRF2BPL-related disorder, which affects brain development and causes delays in learning and thinking skills. They surveyed patients and families to better understand what symptoms appear, when they start, and how they change over time. This is one of the first studies to collect detailed information directly from patients about their experiences with this condition.

WHY IT MATTERSThis is the first large patient-reported study of IRF2BPL-related disorder, which could help doctors recognize the condition earlier and give families a clearer picture of what to expect over time.
Good to knowIRF2BPL-related disorderRead →
ResearchPUBMEDApr 5

Economic Evaluations of Orphan Drugs for Rare Kidney Diseases in Low- and Middle-Income Countries: A Bibliometric Systematic Review With Policy and Evidence Gaps Analysis.

Researchers looked at studies from 2014 to 2024 about the cost and value of special medicines for rare kidney diseases in poorer countries. They found that there isn't much research on whether these expensive medicines are worth the money in these areas. The study shows that doctors and governments need better information to decide if patients should have access to these treatments.

WHY IT MATTERSIf you have a rare kidney disease in a low- or middle-income country, this research highlights why your access to orphan drugs is limited — there's a major gap in evidence about whether these treatments are affordable and effective in your region.
Good to knowRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy

Researchers are looking for people with Down syndrome (Trisomy 21) to join a study about how their immune system works differently and ages over time. Some participants will have had their thymus gland removed, while others won't have, so scientists can compare how this affects immune health. The study will help doctors understand why people with Down syndrome often get more infections and have other immune-related health problems.

WHY IT MATTERSThis trial is now recruiting people with Down syndrome to help researchers understand immune system problems that affect this population — findings could lead to better treatments for infections and other immune conditions common in Trisomy 21.
You can act on thisTrisomy 21Down syndromeRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

Researchers are testing whether children and young adults can use robotic leg braces (called exoskeletons) in their daily lives to help them walk and move around. An exoskeleton is a wearable machine that supports your legs and helps you move if you have difficulty walking. This study will see if these devices can become common tools that help young people with mobility challenges do everyday activities.

WHY IT MATTERSThis trial is recruiting children and young adults with lower limb mobility challenges — if you or your child has difficulty walking due to a neurological or muscular condition, this could offer access to cutting-edge assistive technology at no cost through a major research institution.
👁 Watch this spaceRead →
ResearchUNITERAREApr 5

New Recruiting Trial: Genetic Analysis of Uncommon Disease Presentations in Non-US Populations

Researchers at the National Human Genome Research Institute are starting a study to understand rare genetic diseases by studying people from countries outside the United States. The study will look at how genetic changes cause unusual disease patterns in different populations. This research could help doctors better understand and diagnose rare diseases worldwide.

WHY IT MATTERSThis trial expands rare disease research beyond US populations, which means genetic discoveries could help patients globally who have been underrepresented in previous studies.
👁 Watch this spaceRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma

Researchers are looking for patients with a rare cancer called adrenocortical carcinoma that has come back after surgery. This study will test whether giving radiation therapy before surgery helps remove the cancer more effectively. The trial is just starting and will enroll patients beginning in April 2026.

WHY IT MATTERSThis is the first Phase 1 trial testing preoperative radiation for recurrent adrenocortical carcinoma, offering eligible patients access to a potentially new treatment approach before it becomes widely available.
👁 Watch this spaceadrenocortical carcinomaRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomerulosclerosis

Researchers are testing a new drug called ManNAc to treat primary focal segmental glomerulosclerosis (FSGS), a rare kidney disease that causes scarring and can lead to kidney failure. This is a Phase 2 trial, meaning the drug has already been tested for safety in a small group and now researchers want to see if it actually works to help patients. The trial is now accepting patients and is expected to start in April 2026.

WHY IT MATTERSThis trial offers patients with primary FSGS access to an investigational treatment that may slow or stop kidney damage, with enrollment now open at sites participating in the National Human Genome Research Institute study.
You can act on thisFocal Segmental Glomerulosclerosis (FSGS)Primary Focal Segmental GlomerulosclerosisRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)

Researchers are testing a new drug called CYT107 to help people with HIV who have Kaposi Sarcoma (a type of cancer) and whose immune systems aren't responding well to treatment. CYT107 is designed to boost the immune system to help fight the cancer. This is a Phase 2 trial, meaning it's testing whether the drug works and is safe in a larger group of people. The trial is now accepting patients and will start in April 2026.

WHY IT MATTERSThis trial offers a potential new treatment option for people with HIV-related Kaposi Sarcoma who haven't responded to standard immune-boosting treatments, addressing a significant gap in care for this vulnerable population.
You can act on thisKaposi SarcomaHIV/AIDSRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

Researchers are testing a drug called baricitinib to see if it is safe and works well for patients with Job syndrome who also have lupus-like disease and/or atopic dermatitis (severe itchy skin). Job syndrome is a rare immune system disorder that makes it hard for the body to fight infections and causes skin problems. This is an early-stage study that will check for side effects and how well the drug works.

WHY IT MATTERSThis Phase 1 trial is now actively recruiting patients with Job syndrome complicated by lupus-like disease and/or atopic dermatitis — a rare combination that has limited treatment options and is being studied by the National Institute of Allergy and Infectious Diseases.
💬 Ask your doctorJob syndromeAtopic dermatitisLupus-like diseaseRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms

Researchers are testing a new drug called pacritinib in people ages 12 and older who have myelodysplastic syndromes or myelodysplastic/myeloproliferative neoplasms — rare blood disorders where the bone marrow doesn't make enough healthy blood cells. The drug works by blocking several proteins that may be causing these diseases. This is an early-stage study sponsored by the National Cancer Institute that will start recruiting patients in April 2026.

WHY IT MATTERSThis trial offers patients with myelodysplastic syndromes access to a novel multi-targeted kinase inhibitor that may address disease mechanisms not covered by current standard treatments, with enrollment beginning in April 2026.
👁 Watch this spaceMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies

Researchers are testing a new cancer treatment that takes a patient's own immune cells, modifies them in a lab to recognize and attack their specific cancer, and then puts them back into the body. This Phase 1 trial is for people with blood cancers like leukemia and lymphoma. The treatment is personalized—each patient's cells are customized based on their individual cancer's unique mutations.

WHY IT MATTERSThis trial offers patients with hematologic malignancies access to a cutting-edge personalized immunotherapy that targets their cancer's unique mutations, potentially offering a new treatment option for those who may have limited alternatives.
You can act on thisacute myeloid leukemiaacute lymphoblastic leukemiachronic myeloid leukemiaRead →
Clinical trialUNITERAREApr 5

New Recruiting Trial: The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States

Researchers are testing a new tool called the Esophageal String Test to help diagnose eosinophilic esophagitis, a condition where too many white blood cells build up in the food pipe and cause trouble swallowing. The test uses a small string that you swallow to collect samples from your esophagus. This study is enrolling people in Mali and the United States who have difficulty swallowing.

WHY IT MATTERSThis trial offers a potentially simpler, non-invasive screening method for eosinophilic esophagitis that could reduce the need for traditional endoscopy procedures, particularly for underserved populations in Africa and the US.
You can act on thiseosinophilic esophagitisRead →
ResearchBIORXIVApr 5

Preprint: Burden of rare pathogenic variants suggests disrupted cytoskeletal organisation in the pathogenesis of pulmonary fibrosis

Researchers studied the genes of people with pulmonary fibrosis (a disease where lung tissue becomes scarred and stiff) to find rare genetic changes that might cause the disease. They found that problems in genes related to how cells maintain their structure may play an important role in developing pulmonary fibrosis. This discovery could help doctors better understand why some people develop this serious lung condition.

WHY IT MATTERSIf you or a family member has pulmonary fibrosis, this research could eventually help explain your genetic risk and lead to new treatments targeting the cellular structures that are damaged in this disease.
Good to knowIdiopathic Pulmonary FibrosisPulmonary FibrosisRead →
ResearchBIORXIVApr 5

Preprint: Gene Portals: A Framework for Integrating Clinical, Functional, and Structural Evidence into Rare Disease Variant Classification

Scientists created a new tool called Gene Portals that helps doctors understand whether genetic changes cause rare diseases. Instead of searching through many different websites and databases, doctors can now use one central location that combines patient information, lab test results, and genetic data all in one place. This makes it easier and faster to figure out if a genetic mutation is actually responsible for a patient's rare disease.

WHY IT MATTERSPatients with rare genetic diseases may finally get faster and more accurate diagnoses because doctors will have a standardized way to interpret genetic test results, reducing the chance of misdiagnosis or missed diagnoses.
Good to knowRead →
Clinical trialUNITERAREApr 4

New Recruiting Trial: TF-CBT for Autistic Youth Pilot Implementation - Open Pilot

Researchers at Dartmouth-Hitchcock Medical Center are testing a therapy called TF-CBT (Trauma-Focused Cognitive Behavioral Therapy) to see if it works well for autistic young people. This is a pilot study, which means it's a small test to see if the approach is worth studying more carefully. The study is now accepting participants and is expected to start in April 2026.

WHY IT MATTERSThis trial addresses a significant gap in mental health treatment for autistic youth, as trauma-focused therapies are often adapted without testing whether they work safely and effectively for autistic individuals.
👁 Watch this spaceautism spectrum disorderRead →
Clinical trialUNITERAREApr 4

New Recruiting Trial: A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)

Researchers are testing a new drug called JL15003 to see if it can safely treat glioblastoma, a serious brain cancer that has come back after previous treatment. This is an early-stage study that will check both how safe the drug is and whether it helps patients live longer or feel better. The study is now accepting patients and will run starting in April 2026.

WHY IT MATTERSThis trial offers a potential new treatment option for patients with recurrent glioblastoma, a condition with very limited treatment choices after initial therapy fails.
👁 Watch this spaceglioblastomarecurrent glioblastomaRead →
ResearchBIORXIVApr 4

Preprint: Targeted Long-Read sequencing provides functional validation of variants predicted to alter splicing

Researchers developed a new test called targeted long-read sequencing that can better identify which genetic changes affect how genes are read and used in cells. This test is more accurate than older methods at finding these changes in patients with neurological disorders, and it's faster and cheaper than previous approaches.

WHY IT MATTERSIf you have a neurological disorder where genetic testing hasn't found a clear diagnosis, this method could help doctors identify the actual genetic cause by better detecting splicing variants that standard tests miss.
Good to knowRead →
🔴 BreakingDrug approvalOPENFDAApr 4

FDA Approves FOUNDAYO (ORFORGLIPRON) — New Treatment Available

The FDA has approved a new drug called FOUNDAYO (orforglipron), made by Eli Lilly. This approval means the medication is now available for patients to use. The drug was officially approved on April 1, 2026.

WHY IT MATTERSWithout information about which rare disease FOUNDAYO treats, we cannot specify the patient impact — the article lacks details about the condition it addresses or which patients are eligible.
💬 Ask your doctorRead →
Clinical trialUNITERAREApr 3

New Recruiting Trial: Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants

Researchers at the University of Alabama at Birmingham are looking for premature babies to join a study about pulmonary hypertension—a condition where blood pressure in the lungs gets too high. The study will test different oxygen level targets to see which approach helps prevent or reduce lung problems in preterm infants. This trial is now actively recruiting participants and is expected to start in April 2026.

WHY IT MATTERSThis trial directly addresses a common complication in premature infants where improper oxygen management can cause lasting lung damage, making oxygen saturation targeting strategies critical for improving long-term outcomes in this vulnerable population.
You can act on thispulmonary hypertension in preterm infantsbronchopulmonary dysplasiaRead →
ResearchUNITERAREApr 3

New Recruiting Trial: Stakeholders of Rare Diseases Informing Values In Neuroethics

This is a research study looking for patients and families affected by rare diseases to share their thoughts and values about brain and nerve-related medical decisions. Researchers at St. Jude Children's Research Hospital want to understand what matters most to people living with rare diseases so they can make better ethical decisions in medical research and treatment. The study is now accepting participants and will start in April 2026.

WHY IT MATTERSThis study gives rare disease patients and caregivers a direct voice in shaping how medical ethics and brain-related research decisions are made — your input could influence future treatment guidelines and research practices.
Good to knowRead →
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