Also known as: EU
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
Merck's Enflonsia (clesrovimab) receives EU approval for RSV prevention in infants. Separately, researchers identify a monoclonal antibody cocktail from pediatricians' immune cells that shows potent protection against RSV and hMPV in animal studies.
The EU Critical Medicines Act enters trilogue negotiations as drug shortages persist. The Parliament proposes broader powers for a new coordination group, binding stockpiling, and expanded MEAT procurement criteria. EMA recorded 136 critical shortages from 2022-2024.
Aurobindo Pharma's subsidiaries secured Health Canada approval for bevacizumab biosimilar Bevqolva, an EU distribution deal with STADA for two EMA-approved biosimilars, and US FDA approval for ADQUEY ointment for atopic dermatitis.
Regeneron said the Phase 3 NIMBLE trial of cemdisiran in generalized myasthenia gravis met primary and key secondary endpoints at week 24. The company said a U.S. regulatory application has been submitted and EU filings are planned for 2026.
The FDA approved acalabrutinib plus venetoclax for previously untreated CLL/SLL based on phase 3 AMPLIFY data. The fixed 14-month regimen improved progression-free survival versus chemotherapy.
The European Commission has approved KYGEVVI (doxecitine and doxribtimine) as the first treatment for thymidine kinase 2 deficiency (TK2d), an ultra-rare mitochondrial disease. Clinical studies showed the drug reduces death risk by 95% and helps 84% of patients regain motor functions. The approval covers pediatric and adult patients with symptom onset before age 12.
The European Union has approved a higher 7.2 mg maintenance dose for Wegovy (semaglutide) for chronic weight management. Clinical trial data shows mean weight loss of 20-21% with the 7.2 mg dose compared to 17-18% with the standard 2.4 mg dose. The approval provides clinicians with an on-label option for patients with inadequate response to standard dosing.
Egetis Therapeutics completed its rolling New Drug Application for Emcitate® (tiratricol) for MCT8 deficiency in the USA on January 29, 2026. The drug received European Commission approval in February 2025 and launched in Germany in May 2025. The company also provided updates on Japanese regulatory progress and the status of its Aladote® candidate for paracetamol overdose.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07498179 |
Activation-Socialization Intervention Program for Seniors |
ENROLLING_BY_INVITATION | NA |
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Evaluability and Feasibility of the eHOOD Intervention |
COMPLETED | NA |
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RESCCUE4 - Group CBT for Social Anxiety in Adolescents |
COMPLETED | NA |
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Digital Solutions for bEtter cAre |
RECRUITING | NA |
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Impact of Snoezelen Intervention and Reminiscence Therapy on Seniors' Emotionality and Anxiety |
COMPLETED | NA |
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Reduction of Low-value Prescribing Through Audit and Feedback |
NOT_YET_RECRUITING | NA |
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Impact of Nut Consumption on Mental Health in Young Adults |
RECRUITING | NA |
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Glycyrrhetinic Acid and Acute Irritant Dermatitis |
NOT_YET_RECRUITING | NA |
| NCT07277920 |
Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions |
RECRUITING | |
| NCT07240038 |
Reduction of the Incidence of NAV in Neonatal Units (INBERNAV-Neo) |
RECRUITING |
