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Pharmacology

November's approvals brought the 2025 US total to approximately 39 novel drugs.

• Sevabertinib — HER2 & EGFR kinase inhibitor; accelerated approval for locally advanced / metastatic non-squamous NSCLC.
• Itvisma (onasemnogene abeparvovec) — gene therapy for spinal muscular atrophy; advances in AAV-based gene replacement.
• Tarlatamab-dlle (Imdelltra) — approved for extensive-stage small cell lung cancer based on the DeLLphi-304 trial; bispecific T-cell engager targeting DLL3 × CD3.
• Sibeprenlimab — anti-APRIL monoclonal antibody for IgA nephropathy.
• Ziftomenib — menin inhibitor; approved for relapsed/refractory AML with NPM1 mutations.
• Daratumumab (Darzalex Faspro) — SC formulation — first CD38-directed antibody approved for smoldering multiple myeloma.
• Daratumumab + bortezomib — traditional approval for newly diagnosed light-chain amyloidosis.
• Generic dasatinib — final approval for Ph+ CML and ALL.
• Durvalumab — perioperative treatment of resectable gastric and GEJ adenocarcinoma.
• Pembrolizumab + Enfortumab vedotin — approved for muscle-invasive bladder cancer.

The CHMP meeting of 10–13 November 2025 recommended 10 new medicines for marketing authorisation.

• Dawnzera (donidalorsen) — oral kallikrein inhibitor for routine prevention of hereditary angioedema attacks (≥12 years); orphan-designated.
• GalenVita (⁶⁸Ge/⁶⁸Ga generator) — produces ⁶⁸Ga chloride for PET tumour imaging radiolabelling.
• Inluriyo (imlunestrant) — oral ER degrader (SERD) monotherapy for ER+/HER2− locally advanced or metastatic breast cancer.
• Teplizumab (Teizeild) — first-in-class anti-CD3 mAb to delay onset of stage 3 type 1 diabetes in patients with stage 2 disease (≥8 years); PRIME-supported.
• Vacpertagen — acellular pertussis booster from 12 years; confers passive protection in infancy via maternal immunisation.
• Waskyra (gene therapy) — autologous CD34+ cells with lentiviral WAS-protein vector for Wiskott-Aldrich syndrome; orphan-designated; first gene therapy for this condition.
• Enzalutamide Accordpharma — hybrid approval; enzalutamide for prostate cancer.
• Ondibta — insulin glargine biosimilar for diabetes mellitus.
• Osqay — denosumab biosimilar for osteoporosis and treatment-related bone loss.
• Teduglutide Viatris — generic teduglutide for short bowel syndrome.

Indication extensions: Koselugo (selumetinib, NF1 plexiform neurofibromas), Minjuvi (tafasitamab), Veyvondi (vonicog alfa), Xerava (eravacycline).

Eisai and Biogen advanced the subcutaneous formulation of lecanemab-irmb in November 2025:

• FDA rolling submission completed (26 Nov 2025) for LEQEMBI IQLIK — subcutaneous starting dose under Fast Track status for early Alzheimer's disease.
• Japan PMDA NDA submitted (28 Nov 2025) — if approved, lecanemab would be the first anti-amyloid therapy offering at-home self-injection from treatment initiation.
• CTAD 2025 data — pharmacodynamic evidence confirms lecanemab binds to amyloid-β protofibrils in CSF; mechanism-of-action validated with evidence of reduced neurotoxic tau tangle accumulation.

A landmark Stanford study highlighted in November 2025 identified Epstein-Barr virus (EBV) as a key driver in SLE pathogenesis. EBV-infected B cells were found to be more than 25× more common in lupus patients compared to healthy controls — providing a molecular target for potential future therapies.

Research published in Nature Communications demonstrated that mitochondrial ABHD11 regulates T-cell overactivity. Inhibiting ABHD11 reduces pathological inflammation and delays the development of type 1 diabetes in animal models — potentially safer than broad immunosuppression.

• CD19-targeted CAR-T cells rapidly and persistently eliminated pathogenic B cells, achieving remission in refractory myasthenia gravis and rheumatoid arthritis.
• Teclistamab — bispecific T-cell engager targeting BCMA × CD3 — achieved rapid, sustained remission in severe refractory myasthenia gravis with clearance of pathogenic autoantibodies.

In November 2025, Novo Nordisk (semaglutide) and Eli Lilly (tirzepatide) announced strategic price reductions for their blockbuster obesity drugs, unlocking Medicare and broad insurance reimbursement access.

Orforglipron — the first non-peptide oral GLP-1 receptor agonist — successfully completed Phase III trials in 2025. Unlike injectable GLP-1 analogues, it overcomes injection-related barriers, potentially transforming the treatment landscape for obesity and type 2 diabetes if approved.

The 4th National Conference of Pharmacology and Therapeutics (NAPTICON 2025) was inaugurated at PSG Institute of Medical Sciences & Research, Coimbatore. Theme: "Crafting Clinical Excellence with Pharmacology and Therapeutics."

• Pre-conference workshop: PK-PD Modelling & Simulation in Phase I Clinical Trials
• Simulation-Based Learning in Pharmacotherapeutics
• Drug Analysis using LCMS and AAS
• Annual NAPTIQUIZ · Paper & poster presentations
• Keynotes on pharmacogenomics, precision medicine, essential medicines, and ADR monitoring in herbal products

The CDSCO regulatory panel directed Mankind Pharma to conduct Phase I clinical trials in India for Sintilimab injection, a PD-1 immune checkpoint inhibitor — reinforcing India's growing role in immuno-oncology clinical development.

World Antimicrobial Resistance Awareness Week (18 November 2025) released critical regional resistance data:

• MRSA bloodstream infection resistance: 50.3% in the Eastern Mediterranean Region — highest among all WHO regions.
• Acinetobacter spp. to imipenem: 66.5% globally, with an 11.3% annual increase — fastest-growing resistance pattern worldwide.
• Shigella resistance to azithromycin: 1.2% — lowest globally.
• Klebsiella pneumoniae resistance to cefotaxime showing a positive 5.2% annual decline.

Global Medicine Safety Week (3–9 November 2025) brought attention to the critical underreporting of adverse drug reactions:

This systematic underreporting creates significant gaps in post-marketing safety surveillance, delays identification of pharmacovigilance signals, and limits timely updates to prescribing guidance.

Research published in Bioinformatics (October 2025) demonstrated that large language models (LLMs) combined with drug-related textual information can meaningfully improve the prediction of drug-drug interactions (DDIs) — a potential tool for clinical pharmacology and formulary safety review.

AI models including DeepVariant and AlphaFold are showing promise for predicting individual drug responses and improving precision of genetic variant identification — paving the way for pharmacogenomics-guided prescribing at scale.