MHRA Authorised Biogen’s Higher-dose Spinraza For SMA Treatment
▫️The Medicines And Healthcare Products Regulatory Agency (MHRA) Has Granted Marketing Authorisation to Biogen For A Higher-dose Regimen of Spinraza (Nusinersen) to Treat 5q Spinal Muscular Atrophy (SMA).
▫️SMA Is A Rare Genetic Neuromuscular Condition Affecting Around 1,600 People in The UK, With Around 70 Children Born With The Condition Each Year. The Most Common Form, 5q SMA, Which Accounts For An Estimated 95% of Cases, Is Caused by Changes in A Gene Responsible For Producing Survival Motor Neuron (SMN) Protein.
▫️The Updated Regimen Includes A More Rapid Loading Phase For ‘Treatment-Naïve’ Patients, With Two 50mg doses Given 14 Days Apart, Followed by 28mg Maintenance doses Every Four Months.
▫️The Higher-dose Regimen Is Already Approved in The US, EU, Switzerland And Japan, With Biogen Continuing to Work With Regulators to Expand Access Globally.
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▫️The Medicines And Healthcare Products Regulatory Agency (MHRA) Has Granted Marketing Authorisation to Biogen For A Higher-dose Regimen of Spinraza (Nusinersen) to Treat 5q Spinal Muscular Atrophy (SMA).
▫️SMA Is A Rare Genetic Neuromuscular Condition Affecting Around 1,600 People in The UK, With Around 70 Children Born With The Condition Each Year. The Most Common Form, 5q SMA, Which Accounts For An Estimated 95% of Cases, Is Caused by Changes in A Gene Responsible For Producing Survival Motor Neuron (SMN) Protein.
▫️The Updated Regimen Includes A More Rapid Loading Phase For ‘Treatment-Naïve’ Patients, With Two 50mg doses Given 14 Days Apart, Followed by 28mg Maintenance doses Every Four Months.
▫️The Higher-dose Regimen Is Already Approved in The US, EU, Switzerland And Japan, With Biogen Continuing to Work With Regulators to Expand Access Globally.
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Pfizer Received EC Approval For Hympavzi to Treat Haemophilia
▫️Pfizer Has Received The European Commission’s (EC) Marketing Authorisation For Expanding The Approved Hympavzi (Marstacimab) Indication to Treat Haemophilia A or B With Inhibitors in Patients Aged 12 Years And Above.
▫️The Approval Covers Adults And Adolescents in The European Union (EU) Who Weigh at Least 35kg And Have Haemophilia A (Factor VIII Deficiency) With Factor VIII Inhibitors, or Haemophilia B (Factor IX Deficiency) With Factor IX Inhibitors.
▫️Thrombosis Was Reported As The Most Serious Adverse Event.
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▫️Pfizer Has Received The European Commission’s (EC) Marketing Authorisation For Expanding The Approved Hympavzi (Marstacimab) Indication to Treat Haemophilia A or B With Inhibitors in Patients Aged 12 Years And Above.
▫️The Approval Covers Adults And Adolescents in The European Union (EU) Who Weigh at Least 35kg And Have Haemophilia A (Factor VIII Deficiency) With Factor VIII Inhibitors, or Haemophilia B (Factor IX Deficiency) With Factor IX Inhibitors.
▫️Thrombosis Was Reported As The Most Serious Adverse Event.
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Sanofi’s Tzield Gets Expanded FDA Approval For Early-Stage Type 1 Diabetes
▫️Sanofi’s Tzield (Teplizumab) Has Received Expanded Approved From The US FDA, Allowing It to Be Used For Children Aged One Year And Older With Stage 2 Type 1 Diabetes (T1D) to Delay Progression to Stage 3 Disease.
▫️The Decision Extends The Therapy’s Previous Approval, Which Covered Patients Aged Eight Years And Above, And Was Granted Under A Priority Review.
▫️Tzield Was First Approved in The US in 2022 For Delaying The Onset of Stage 3 T1D in Adults And Children Aged Eight Years And Older With Stage 2 Disease.
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▫️Sanofi’s Tzield (Teplizumab) Has Received Expanded Approved From The US FDA, Allowing It to Be Used For Children Aged One Year And Older With Stage 2 Type 1 Diabetes (T1D) to Delay Progression to Stage 3 Disease.
▫️The Decision Extends The Therapy’s Previous Approval, Which Covered Patients Aged Eight Years And Above, And Was Granted Under A Priority Review.
▫️Tzield Was First Approved in The US in 2022 For Delaying The Onset of Stage 3 T1D in Adults And Children Aged Eight Years And Older With Stage 2 Disease.
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Scientists Find Hidden Brain Nutrient Deficit That May Fuel Anxiety
▫️A Major Analysis of Brain Scans Found That People With Anxiety Disorders Have Noticeably Lower Levels of Choline, A Nutrient Crucial For Healthy Brain Function. The Strongest Evidence Appeared in The Prefrontal Cortex, The Region Tied to Emotional Control And Decision-Making.
▫️The Finding Comes From A Study Published in Molecular Psychiatry, A Nature Journal, And Offers A Rare Look at The Chemistry That May Be Connected to Anxiety Across Several Different Diagnoses.
@MedicalNewsToday
▫️A Major Analysis of Brain Scans Found That People With Anxiety Disorders Have Noticeably Lower Levels of Choline, A Nutrient Crucial For Healthy Brain Function. The Strongest Evidence Appeared in The Prefrontal Cortex, The Region Tied to Emotional Control And Decision-Making.
▫️The Finding Comes From A Study Published in Molecular Psychiatry, A Nature Journal, And Offers A Rare Look at The Chemistry That May Be Connected to Anxiety Across Several Different Diagnoses.
@MedicalNewsToday
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FDA Approved Antiretroviral Idvynso For Adults With HIV
▫️The US Food And Drug Administration (FDA) Has Approved Merck’s IDVYNSO™, A New, Two-Drug Single-Tablet Regimen of 100 mg Doravirine And 0.25 mg Islatravir, For The Treatment of HIV-1 Infection in Adults to Replace The Current Antiretroviral Regimen in Those Who Are Virologically Suppressed (HIV-1 RNA Less Than 50 Copies per mL) On A Stable Antiretroviral Regimen With No History of Virologic Treatment Failure And No Known Substitutions Associated With Resistance to Doravirine.
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▫️The US Food And Drug Administration (FDA) Has Approved Merck’s IDVYNSO™, A New, Two-Drug Single-Tablet Regimen of 100 mg Doravirine And 0.25 mg Islatravir, For The Treatment of HIV-1 Infection in Adults to Replace The Current Antiretroviral Regimen in Those Who Are Virologically Suppressed (HIV-1 RNA Less Than 50 Copies per mL) On A Stable Antiretroviral Regimen With No History of Virologic Treatment Failure And No Known Substitutions Associated With Resistance to Doravirine.
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Scientists Discover Vitamin B2 May Help Cancer Cells Survive
▫️Scientists Have Uncovered A Surprising Dark Side to Vitamin B2: It May Help Cancer Cells Stay Alive. The Vitamin Supports A Cellular Shield That Protects Tumors From Ferroptosis, A Form of Programmed Cell Death Linked to Cancer Suppression.
▫️Also Known As Riboflavin, Vitamin B2 Cannot be Produced by The Body And Must Come From Food Sources Such As Dairy Products, Eggs, Meat, And Green Vegetables.
▫️The Study Was Published in Nature Cell Biology.
@MedicalNewsToday
▫️Scientists Have Uncovered A Surprising Dark Side to Vitamin B2: It May Help Cancer Cells Stay Alive. The Vitamin Supports A Cellular Shield That Protects Tumors From Ferroptosis, A Form of Programmed Cell Death Linked to Cancer Suppression.
▫️Also Known As Riboflavin, Vitamin B2 Cannot be Produced by The Body And Must Come From Food Sources Such As Dairy Products, Eggs, Meat, And Green Vegetables.
▫️The Study Was Published in Nature Cell Biology.
@MedicalNewsToday
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Partner Therapeutics Secures FDA Approval For Bizengri
▫️Partner Therapeutics Has Received The US Food And Drug Administration (FDA) Approval For Bizengri (Zenocutuzumab) to Treat Adults With Advanced, Unresectable or Metastatic Cholangiocarcinoma Harbouring A Neuregulin 1 (NRG1) Gene Fusion And Who Have Progressed On or After Prior Systemic Therapy.
▫️Bizengri Previously Gained Accelerated Approval in 2024 For Use in Non-Small Cell Lung Cancer And Pancreatic Adenocarcinoma in Patients Harboring An NRG1 Fusion After Systemic Therapy.
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▫️Partner Therapeutics Has Received The US Food And Drug Administration (FDA) Approval For Bizengri (Zenocutuzumab) to Treat Adults With Advanced, Unresectable or Metastatic Cholangiocarcinoma Harbouring A Neuregulin 1 (NRG1) Gene Fusion And Who Have Progressed On or After Prior Systemic Therapy.
▫️Bizengri Previously Gained Accelerated Approval in 2024 For Use in Non-Small Cell Lung Cancer And Pancreatic Adenocarcinoma in Patients Harboring An NRG1 Fusion After Systemic Therapy.
@MedicalNoteBook
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Scientists Link Childhood Stress to Lifelong Digestive Issues
▫️A New Study Published in Gastroenterology Suggests That Stress During Early Life May Increase The Risk of Digestive Problems Later On. Researchers Found That These Effects Are Linked to Changes in Both The Gut And The Sympathetic Nervous System.
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▫️A New Study Published in Gastroenterology Suggests That Stress During Early Life May Increase The Risk of Digestive Problems Later On. Researchers Found That These Effects Are Linked to Changes in Both The Gut And The Sympathetic Nervous System.
@MedicalNoteBook
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FDA Approved Enhertu For Two HER2-Positive Early Breast Cancer Indications
▫️The US Food And Drug Administration (FDA) Has Approved Daiichi Sankyo And AstraZeneca’s Enhertu (Trastuzumab Deruxtecan) For Two New Indications in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer.
▫️In The Neoadjuvant Setting, The Therapy, Followed by A Regimen of Taxane, Trastuzumab, And Pertuzumab (THP), Is Now Approved For Adults With HER2-Positive Stage 2 or Stage 3 Breast Cancer.
▫️For The Adjuvant Setting, The Approval Applies to Adults With HER2-Positive Breast Cancer With Residual Invasive Disease After Prior Treatment With Trastuzumab (With or Without Pertuzumab) And A Taxane-Based Regimen.
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▫️The US Food And Drug Administration (FDA) Has Approved Daiichi Sankyo And AstraZeneca’s Enhertu (Trastuzumab Deruxtecan) For Two New Indications in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer.
▫️In The Neoadjuvant Setting, The Therapy, Followed by A Regimen of Taxane, Trastuzumab, And Pertuzumab (THP), Is Now Approved For Adults With HER2-Positive Stage 2 or Stage 3 Breast Cancer.
▫️For The Adjuvant Setting, The Approval Applies to Adults With HER2-Positive Breast Cancer With Residual Invasive Disease After Prior Treatment With Trastuzumab (With or Without Pertuzumab) And A Taxane-Based Regimen.
@MedicalNoteBook
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Silent Heart Attacks May Speed Cognitive Decline
▫️A Recent Study Published in The Journal Stroke Found That People With A Self-Reported History or Electrocardiogram (ECG) Evidence of A Previous Myocardial Infarction Experienced A Faster Decline in Global Cognitive Function.
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▫️A Recent Study Published in The Journal Stroke Found That People With A Self-Reported History or Electrocardiogram (ECG) Evidence of A Previous Myocardial Infarction Experienced A Faster Decline in Global Cognitive Function.
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Scientists Say A Daily Multivitamin May Help Slow Aging
▫️Researchers From Mass General Brigham Analyzed Data From Older Adults Who Participated in A Randomized Clinical Trial And Found That Two Years of Multivitamin Use Was Linked to Slower Biological Aging Across Several DNA-Based Measurements.
The Effect Was Equal to Roughly Four Fewer Months of Biological Aging Over The Course of The Study.
▫️The Findings Were Published in Nature Medicine.
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▫️Researchers From Mass General Brigham Analyzed Data From Older Adults Who Participated in A Randomized Clinical Trial And Found That Two Years of Multivitamin Use Was Linked to Slower Biological Aging Across Several DNA-Based Measurements.
The Effect Was Equal to Roughly Four Fewer Months of Biological Aging Over The Course of The Study.
▫️The Findings Were Published in Nature Medicine.
@MedicalNoteBook
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Prenatal Chemical Mixtures May Influence Fetal Growth And Placental Health
▫️Pregnancy Represents A Particularly Sensitive Window, As Hormonal Balance Is Essential For Placental Development And Fetal Growth.
▫️Common Environmental Chemicals Could Affect Birthweight And Placental Function, According to A New Study Published in Environmental Science & Technology And Led by The Barcelona Institute For Global Health (ISGlobal).
▫️The Study Included 734 Participants From The Barcelona Life Study Cohort (BiSC), Recruited Between 2018 And 2021.
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▫️Pregnancy Represents A Particularly Sensitive Window, As Hormonal Balance Is Essential For Placental Development And Fetal Growth.
▫️Common Environmental Chemicals Could Affect Birthweight And Placental Function, According to A New Study Published in Environmental Science & Technology And Led by The Barcelona Institute For Global Health (ISGlobal).
▫️The Study Included 734 Participants From The Barcelona Life Study Cohort (BiSC), Recruited Between 2018 And 2021.
@MedicalNoteBook
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FDA Approved First-in-Class Hypertension Drug From AstraZeneca
▫️Baxdrostat (Baxfendy) Has Been Approved by The US Food And Drug Administration (FDA) For The Treatment of Patients With Hypertension Who Have Inadequately Controlled Blood Pressure Despite Taking Other Antihypertensive Medications, Drugmaker AstraZeneca Announced Monday.
▫️The Medication Is The First Aldosterone Synthase Inhibitor to Hit The US Market, Although There Are Others - Like Lorundrostat (Mineralys Therapeutics) - in The Pipeline.
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▫️Baxdrostat (Baxfendy) Has Been Approved by The US Food And Drug Administration (FDA) For The Treatment of Patients With Hypertension Who Have Inadequately Controlled Blood Pressure Despite Taking Other Antihypertensive Medications, Drugmaker AstraZeneca Announced Monday.
▫️The Medication Is The First Aldosterone Synthase Inhibitor to Hit The US Market, Although There Are Others - Like Lorundrostat (Mineralys Therapeutics) - in The Pipeline.
@MedicalNoteBook
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Azithromycin Fails to Improve Severe Wheezing in Preschool Children
▫️A Study Led by Researchers at The University of Arizona College of Medicine Showed That Giving The Antibiotic Azithromycin Did Not Help Preschool Children Seen in The Hospital Emergency Room With Bouts of Severe Wheezing.
▫️The Trial Results Were Reported May 18 in The New England Journal of Medicine And Presented at The American Thoracic Society Meeting at The Same Time in Orlando.
▫️Wheezing And Asthma Are Responsible For The Highest Rates of Hospitalization in Children Under Five Years Old.
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▫️A Study Led by Researchers at The University of Arizona College of Medicine Showed That Giving The Antibiotic Azithromycin Did Not Help Preschool Children Seen in The Hospital Emergency Room With Bouts of Severe Wheezing.
▫️The Trial Results Were Reported May 18 in The New England Journal of Medicine And Presented at The American Thoracic Society Meeting at The Same Time in Orlando.
▫️Wheezing And Asthma Are Responsible For The Highest Rates of Hospitalization in Children Under Five Years Old.
@MedicalNoteBook
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FDA Approved OTC Switch For Topical Acne Treatment
▫️The FDA Has Approved A Prescription-to-Over The Counter (OTC) Switch For A Topical Combination Adapalene-Benzoyl Peroxide Product Currently Approved For Acne in Individuals Aged 12 Years And Older, According to A Press Release From The Manufacturer, Galderma.
▫️The Fixed-dose Combination Product, Marketed As Differin Epiduo Acne Gel (Adapalene 0.1% And Benzoyl Peroxide 2.5%) Was Approved As A Prescription Acne Treatment in December 2008 For Patients Aged 12 Years And Older.
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▫️The FDA Has Approved A Prescription-to-Over The Counter (OTC) Switch For A Topical Combination Adapalene-Benzoyl Peroxide Product Currently Approved For Acne in Individuals Aged 12 Years And Older, According to A Press Release From The Manufacturer, Galderma.
▫️The Fixed-dose Combination Product, Marketed As Differin Epiduo Acne Gel (Adapalene 0.1% And Benzoyl Peroxide 2.5%) Was Approved As A Prescription Acne Treatment in December 2008 For Patients Aged 12 Years And Older.
@MedicalNoteBook
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Simple Blood Count May Help Predict Flare-Up Risk in Asthma
▫️Higher Baseline Counts of Blood Eosinophils (EOS) Were Associated With An Increased Risk For Exacerbations in Patients With Asthma Over 1 Year, And Higher Baseline Levels of Fractional Exhaled Nitric Oxide (FeNO) Were Linked to Increased Odds of Exacerbations Treated With Only Oral Corticosteroids (OCS) in Asthma And Asthma Plus Chronic Obstructive Pulmonary Disease (COPD) But Linked to A Decreased Risk For All Exacerbations in COPD.
▫️It Was Published Online on April 21, 2026, in Thorax.
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▫️Higher Baseline Counts of Blood Eosinophils (EOS) Were Associated With An Increased Risk For Exacerbations in Patients With Asthma Over 1 Year, And Higher Baseline Levels of Fractional Exhaled Nitric Oxide (FeNO) Were Linked to Increased Odds of Exacerbations Treated With Only Oral Corticosteroids (OCS) in Asthma And Asthma Plus Chronic Obstructive Pulmonary Disease (COPD) But Linked to A Decreased Risk For All Exacerbations in COPD.
▫️It Was Published Online on April 21, 2026, in Thorax.
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AstraZeneca, Daiichi Sankyo’s Datroway Received FDA Approval For TNBC
▫️AstraZeneca And Daiichi Sankyo Have Secured Approval From The US Food And Drug Administration (FDA) For Datroway (Datopotamab Deruxtecan) to Treat Metastatic Triple-Negative Breast Cancer (TNBC).
▫️The Approval Allows Datroway to Be Used As A First-Line Treatment For Adults With Unresectable or Metastatic TNBC Who Cannot Receive Programmed Cell Death Protein 1 (PD-1) or PD-L1 Inhibitor Therapy.
▫️This Is Said to Be The First Approval of A TROP2-Directed Antibody Drug Conjugate (ADC) in This Patient Group.
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▫️AstraZeneca And Daiichi Sankyo Have Secured Approval From The US Food And Drug Administration (FDA) For Datroway (Datopotamab Deruxtecan) to Treat Metastatic Triple-Negative Breast Cancer (TNBC).
▫️The Approval Allows Datroway to Be Used As A First-Line Treatment For Adults With Unresectable or Metastatic TNBC Who Cannot Receive Programmed Cell Death Protein 1 (PD-1) or PD-L1 Inhibitor Therapy.
▫️This Is Said to Be The First Approval of A TROP2-Directed Antibody Drug Conjugate (ADC) in This Patient Group.
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Maternal Nonnarcotic Analgesic Allergy Labels Linked to Eclampsia and Preterm Birth
▫️Maternal Nonnarcotic Analgesic Allergy Labels (NNAALs) Were Linked to A More Than 60% Higher Risk For Eclampsia And A Nearly 20% Higher Risk For Preterm Birth.
▫️Infants Born to Individuals With NNAALs Faced A Nearly 50% Higher Risk For Neonatal Opioid Withdrawal Syndrome And Longer Hospital Stays.
▫️It Was Published Online in The Journal of Allergy And Clinical Immunology: In Practice.
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▫️Maternal Nonnarcotic Analgesic Allergy Labels (NNAALs) Were Linked to A More Than 60% Higher Risk For Eclampsia And A Nearly 20% Higher Risk For Preterm Birth.
▫️Infants Born to Individuals With NNAALs Faced A Nearly 50% Higher Risk For Neonatal Opioid Withdrawal Syndrome And Longer Hospital Stays.
▫️It Was Published Online in The Journal of Allergy And Clinical Immunology: In Practice.
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Popular Anti-Aging Drug Combo Caused Severe Brain Damage in Mice
▫️A Drug Combo Widely Explored For Anti-Aging May Actually Damage The Brain, According to New Mouse Research Showing Severe Loss of Myelin And Changes Linked to “Chemo Brain.”
▫️The Findings, Published in PNAS, Showed That The Drug Pairing Dasatinib+Quercetin (D+Q) Damaged Myelin, The Protective Coating That Surrounds Nerve Fibers And Helps Electrical Signals Travel Efficiently Through The Brain And Body.
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▫️A Drug Combo Widely Explored For Anti-Aging May Actually Damage The Brain, According to New Mouse Research Showing Severe Loss of Myelin And Changes Linked to “Chemo Brain.”
▫️The Findings, Published in PNAS, Showed That The Drug Pairing Dasatinib+Quercetin (D+Q) Damaged Myelin, The Protective Coating That Surrounds Nerve Fibers And Helps Electrical Signals Travel Efficiently Through The Brain And Body.
@MedicalNoteBook
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New Depression Treatment Targets The Immune System Instead of The Brain
▫️Immunotherapy May Offer A Completely New Way to Treat People With Difficult-to-Treat Depression, According to A University of Bristol-Led Clinical Trial Published in JAMA Psychiatry On May 20.
▫️In The Small Pilot Study, Researchers Tested Whether Tocilizumab, A Drug Commonly Prescribed For Inflammatory Conditions Such As Rheumatoid Arthritis, Could Ease Depression Symptoms in Patients Who Had Not Improved With Standard Antidepressants.
▫️One Inflammatory Protein Drawing Particular Attention Is Interleukin 6 (IL-6), Which Helps Regulate The Body's Immune Response. Previous Studies Have Linked Higher IL-6 Levels to Depression.
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▫️Immunotherapy May Offer A Completely New Way to Treat People With Difficult-to-Treat Depression, According to A University of Bristol-Led Clinical Trial Published in JAMA Psychiatry On May 20.
▫️In The Small Pilot Study, Researchers Tested Whether Tocilizumab, A Drug Commonly Prescribed For Inflammatory Conditions Such As Rheumatoid Arthritis, Could Ease Depression Symptoms in Patients Who Had Not Improved With Standard Antidepressants.
▫️One Inflammatory Protein Drawing Particular Attention Is Interleukin 6 (IL-6), Which Helps Regulate The Body's Immune Response. Previous Studies Have Linked Higher IL-6 Levels to Depression.
@MedicalNoteBook
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