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New updates in internal medicine from April 2025 to till date

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I now have comprehensive data across all subspecialties. Let me compile the full update.

Internal Medicine Major Updates: April 2025 - June 2026

A comprehensive review across all subspecialties, covering major FDA drug approvals, guideline changes, and landmark clinical trials.

CARDIOLOGY

New Drug Approvals

Oral Semaglutide (Rybelsus) - CV risk reduction (Approved Oct 17, 2025) The FDA expanded the indication of oral semaglutide 7 mg and 14 mg to include cardiovascular risk reduction in patients with type 2 diabetes (T2D), regardless of prior cardiovascular events. This makes it the only oral GLP-1 receptor agonist approved for this indication. Based on the SOUL trial, which showed a 14% relative reduction in major adverse cardiovascular events (MACE) vs. placebo over 4 years. [PMID: 40156843]
Finerenone (Kerendia) - Heart failure (Approved 2025) Expanded FDA approval to cover heart failure with ejection fraction ≥40% (HFmrEF/HFpEF), a population with historically limited pharmacological options. The non-steroidal mineralocorticoid receptor antagonist joins SGLT2 inhibitors as one of the few therapies proven to benefit this group.
Vutrisiran (Amvuttra) - ATTR cardiomyopathy (New indication, 2025) Approved for cardiomyopathy caused by wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), reducing cardiovascular mortality, CV hospitalizations, and urgent heart failure visits. RNAi therapy delivered as quarterly subcutaneous injection.
Aficamten (Myqorzo) - Obstructive HCM (Approved Dec 19, 2025) A novel allosteric cardiac myosin inhibitor approved for symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Based on the SEQUOIA-HCM trial, where aficamten showed +1.8 mL/kg/min peak VO2 improvement vs. placebo. Available in 5/10/15/20 mg tablets.
Lerodalcibep (Lerochol) - LDL-C lowering (Approved Dec 15, 2025) A third-generation PCSK9 inhibitor - a once-monthly, small-volume subcutaneous injection. Based on the LIBerate phase 3 program (5 global trials), including non-inferiority vs. evolocumab in homozygous familial hypercholesterolemia (LIBerate-HoFH trial).
Etripamil (Cardamyst) - PSVT (Approved Dec 12, 2025) A self-administered nasal spray for acute termination of paroxysmal supraventricular tachycardia (PSVT) episodes.
Baxdrostat (Baxfendy) - Hypertension (Approved May 15, 2026) A selective aldosterone synthase inhibitor (CYP11B2 inhibitor) approved for hypertension in combination with other antihypertensives - first-in-class for resistant hypertension with a particularly relevant role in primary aldosteronism-related hypertension.

Major Guidelines

AHA/ACC Joint Hypertension Guideline Update (August 14, 2025) A major joint AHA/ACC guideline update promoting earlier blood pressure treatment and intervention, with emphasis on:
  • Lowering BP threshold to initiate pharmacotherapy
  • Lifestyle modification emphasis (sodium/alcohol restriction, physical activity, DASH diet)
  • Home BP monitoring and regular screening for primary aldosteronism
  • Goal of reducing downstream CV events, kidney disease, and dementia
International Lipid Expert Panel (ILEP) - Stroke Prevention (2026) Consensus paper on lipid management for primary and secondary stroke prevention, updating LDL-C targets and statin/non-statin therapy recommendations. [PMID: 41249078]

Landmark Trials

  • CONFIDENCE trial (NEJM, Aug 2025): Finerenone + empagliflozin combination in CKD + T2D showed additive reduction in UACR compared to either agent alone, supporting combination use. [PMID: 40470996]
  • EMMY trial extension: CA-125 as a biomarker of HF response to empagliflozin post-AMI, supporting early SGLT2i use after myocardial infarction. [PMID: 41430429]
  • Fish oil supplementation (NEJM, Jan 2026): RCT in hemodialysis patients showed no significant cardiovascular benefit from fish-oil supplementation. [PMID: 41201837]

ENDOCRINOLOGY & DIABETES / OBESITY

New Drug Approvals

Paltusotine (Palsonify) - Acromegaly (Approved Sep 25, 2025) First oral somatostatin analog for acromegaly in adults who had inadequate response to surgery or for whom surgery is not an option.
Plozasiran (Redemplo) - Familial chylomicronemia syndrome (Approved Nov 18, 2025) An RNAi therapy (siRNA) targeting apoC-III for severe hypertriglyceridemia in familial chylomicronemia syndrome. Reduces triglycerides via liver-targeted gene silencing.
Insulin Icodec (Awiqli) - Type 2 Diabetes (Approved Mar 26, 2026) Once-weekly basal insulin for T2D - a major convenience advance replacing daily basal insulin injections.
Orforglipron (Foundayo) - Obesity (Approved Apr 1, 2026) First oral, non-peptide GLP-1 receptor agonist approved for weight management in adults with obesity or overweight with comorbidities. Offers a pill-based alternative to injectable GLP-1 agents.

Major Guidelines

Obesity Redefined - Lancet Commission (January 14, 2025) A landmark Lancet Diabetes & Endocrinology commission separated obesity into:
  • Preclinical obesity - elevated adiposity as a risk factor, but without organ dysfunction
  • Clinical obesity - a standalone disease with direct organ/tissue dysfunction BMI alone is insufficient; clinicians should confirm excess adiposity using ≥2 anthropometric criteria (e.g., waist circumference) or direct body composition measures.
Pharmacotherapy for Obesity - 2025 Clinical Practice Guideline Update (CMAJ, Aug 2025) Updated recommendations for GLP-1 agonists, dual agonists (tirzepatide), and combined approaches for adult obesity management. [PMID: 40789597]
Hypoparathyroidism Best Practice Recommendations (2025) Updated comprehensive management recommendations. [PMID: 40581321]

Landmark Trials

  • SOUL Trial (Circulation, 2025): Oral semaglutide reduced MACE by 14% in T2D; subgroup analyses showed benefit regardless of baseline SGLT2i use. [PMID: 40156843]
  • SURPASS-2 post hoc (Diabetologia, May 2026): Tirzepatide significantly outperformed semaglutide in achieving composite therapeutic targets in T2D (HbA1c, weight, lipids). [PMID: 41419618]
  • Living NMA - Diabetes Medications (BMJ, Aug 2025): Tirzepatide shows superior HbA1c reduction and weight loss vs. all other diabetes agents in updated network meta-analysis. [PMID: 40813122]
  • Intermittent Fasting NMA (BMJ, Jun 2025): Time-restricted eating strategies show comparable weight loss to continuous caloric restriction, with additional cardiometabolic benefits. [PMID: 40533200]

NEPHROLOGY

New Drug Approvals

Atrasentan (Vanrafia) - IgA Nephropathy (Approved Feb 4, 2025) An endothelin A receptor antagonist approved to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. First therapy specifically targeting the endothelin pathway in kidney disease.
Sibeprenlimab (Voyxact) - IgA Nephropathy (Approved Nov 25, 2025) An anti-APRIL monoclonal antibody (accelerated approval) to reduce proteinuria in primary IgAN. Targets the B-cell survival factor APRIL, reducing IgA production at its source.

Landmark Trials

  • CONFIDENCE (NEJM, Aug 2025): Finerenone + empagliflozin combination in CKD + T2D showed additive benefits; supports dual therapy as a new standard. [PMID: 40470996]
  • Fish oil in hemodialysis (NEJM, Jan 2026): No CV benefit demonstrated in dialysis patients with fish-oil supplements. [PMID: 41201837]

INFECTIOUS DISEASE

New Drug Approvals

Gepotidacin (Blujepa) - Uncomplicated UTI (Approved Mar 25, 2025) First-in-class triazaacenaphthylene antibiotic (bacterial topoisomerase II inhibitor) for uncomplicated UTIs. Novel mechanism circumvents fluoroquinolone resistance.
Zoliflodacin (Nuzolvence) - Gonorrhea (Approved Dec 12, 2025) First-in-class spiropyrimidinetrione antibiotic for uncomplicated urogenital gonorrhea. Critical given rising ceftriaxone-resistant Neisseria gonorrhoeae.
Clesrovimab (Enflonsia) - RSV prophylaxis (Approved Sep 6, 2025) Long-acting monoclonal antibody for RSV prophylaxis in neonates and infants, joining nirsevimab as a prophylactic option.
Lenacapavir (Sunlenca) - HIV PrEP (CDC Guidelines, Sep 2025) CDC issued clinical recommendations for lenacapavir as twice-yearly injectable HIV pre-exposure prophylaxis (PrEP). Based on PURPOSE 1 and PURPOSE 2 trials showing near-100% HIV prevention efficacy with 6-monthly subcutaneous injections. [PMID: 40966169]
Cefepime + Zidebactam (Zaynich) - Complicated UTI/MDR organisms (Approved May 29, 2026) A beta-lactam/beta-lactam enhancer combination for complicated UTIs including pyelonephritis caused by susceptible organisms, including carbapenem-resistant Enterobacteriaceae.
Ensitrelvir (Xocova) - COVID-19 post-exposure prophylaxis (Approved May 29, 2026) Oral SARS-CoV-2 3CL protease inhibitor approved for COVID-19 post-exposure prophylaxis (PEP) within 3 days of exposure. Based on the SCORPIO-PEP phase 3 trial.

Key Guidelines

  • Dutch MDRO Hospital Prevention Guideline, 2024 Update published 2025: Updated recommendations for controlling multidrug-resistant organisms in hospital settings. [PMID: 41204306]

PULMONOLOGY & CRITICAL CARE

New Drug Approvals

Brensocatib (Brinsupri) - Bronchiectasis (Approved Dec 8, 2025) First-ever approved therapy for non-cystic fibrosis bronchiectasis (NCFB). A dipeptidyl peptidase 1 (DPP1) inhibitor that reduces neutrophil elastase activity in the airways, addressing a disease with no prior pharmacological standard of care.
Depemokimab (Exdensur) - Severe Eosinophilic Asthma (Approved Dec 16, 2025) An ultra-long-acting anti-IL-5 monoclonal antibody for add-on maintenance therapy in severe eosinophilic asthma. Once every 6-month dosing.

Landmark Trials

  • COPD exacerbation meta-analysis (BMJ Open, Jul 2025): EXACOS/AVOIDEX pooled analysis confirms high risk of recurrent exacerbations and mortality following a COPD exacerbation, reinforcing aggressive post-exacerbation management. [PMID: 40707144]
  • Noradrenaline dose-response in critically ill (Crit Care, Nov 2025): Systematic review and meta-analysis showed higher noradrenaline doses are independently associated with increased mortality in ICU patients; supports careful dose titration. [PMID: 41267052]

GASTROENTEROLOGY & HEPATOLOGY

New Drug Approvals

Linerixibat (Lynavoy) - Primary Biliary Cholangitis (Approved Mar 17, 2026) First approved treatment for cholestatic pruritus in primary biliary cholangitis (PBC) - an ileal bile acid transporter (IBAT) inhibitor that reduces bile acid reabsorption.
Bulevirtide (Hepcludex) - Chronic Hepatitis D (Approved May 22, 2026) First approved treatment for chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. HDV is the most severe form of viral hepatitis.

HEMATOLOGY & ONCOLOGY

New Drug Approvals (Selected internal medicine-relevant)

Fitusiran (Qfitlia) - Hemophilia A/B (Approved Mar 28, 2025) An RNAi therapy (siRNA targeting antithrombin) for prevention/reduction of bleeding in hemophilia A or B, including patients with inhibitors.
Linvoseltamab (Lynozyfic) - Multiple Myeloma (Approved Feb 7, 2025) Bispecific antibody (BCMA x CD3) for relapsed/refractory multiple myeloma after ≥4 prior lines.
Ciltacabtagene autoleucel (Carvykti) - Multiple Myeloma CARTITUDE-4 trial comparison vs. physician choice showed superior PFS in lenalidomide-refractory myeloma, supporting earlier CAR-T use. [PMID: 40768190]
Sonrotoclax (Beqalzi) - Mantle Cell Lymphoma (Approved May 13, 2026) BCL-2 inhibitor for relapsed/refractory mantle cell lymphoma after ≥2 prior lines including BTKi.
Rilzabrutinib (Wayrilz) - Immune Thrombocytopenia (2025) BTK inhibitor approved for persistent/chronic ITP in patients with insufficient response to prior therapies.
Narsoplimab (Yartemlea) - HCT-TMA (2025) First approved therapy for hematopoietic stem cell transplant-related thrombotic microangiopathy.

Landmark Trials

  • Checkpoint inhibitors in early NSCLC (meta-analysis, Clin Transl Oncol, Apr 2026): Adjuvant immune checkpoint inhibitors significantly improve disease-free survival in resected early-stage NSCLC, supporting broader adoption. [PMID: 41148491]
  • KEYNOTE-590 5-year follow-up (ESMO Open, Dec 2025): Pembrolizumab + chemotherapy continues to show sustained OS benefit over chemotherapy alone in advanced esophageal cancer at 5-year follow-up. [PMID: 41259897]
  • Anthracycline-related heart failure in AML (Leukemia, Jan 2026): Systematic review quantified HF incidence during AML induction, informing cardio-oncology surveillance strategies. [PMID: 41073560]

COMING IN JUNE 2026 (Pending FDA Decisions)

DrugIndicationPDUFA Date
EnsitrelvirCOVID-19 post-exposure prophylaxisJun 16, 2026
OlezarsenSevere hypertriglyceridemiaJun 30, 2026
NASP (sirolimus + pegadricase)Uncontrolled goutJun 27, 2026
VeligrotugThyroid eye diseaseJun 30, 2026

KEY THEMES ACROSS SPECIALTIES (April 2025 - June 2026)

  1. GLP-1/dual agonist dominance - Semaglutide, tirzepatide, and now the first oral non-peptide GLP-1 (orforglipron) expanding cardiovascular, renal, and metabolic indications.
  2. RNAi/siRNA therapies entering mainstream - Vutrisiran (ATTR), fitusiran (hemophilia), plozasiran (hypertriglyceridemia) represent a maturing RNA therapeutic class.
  3. Combination CKD therapy - Finerenone + SGLT2i combination now evidence-based; triple-threat with RAS blockade being studied.
  4. Novel antibiotic classes - Gepotidacin and zoliflodacin address urgent AMR gaps in UTI and gonorrhea.
  5. HIV prevention revolution - Twice-yearly lenacapavir PrEP with ~100% efficacy reshapes HIV prevention strategy.
  6. Precision cardiology - HCM (aficamten), ATTR-CM (vutrisiran), resistant hypertension (baxdrostat) now have tailored pharmacotherapies.
  7. First-ever therapies - Bronchiectasis (brensocatib), hepatitis D (bulevirtide), IgAN (atrasentan/sibeprenlimab), PBC pruritus (linerixibat) - multiple "first approved" milestones.
Sources: FDA Novel Drug Approvals 2025/2026, PubMed (PMIDs cited inline), AHA/ACC, CDC MMWR, HCPLive Cardiology Year in Review, Nature Reviews Drug Discovery. Current as of June 3, 2026.
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