Tag: EMA
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Six Medicines Recommended for EU Approval by CHMP (Jan 2026 Meeting)
Overview: CHMP’s January 2026 meeting highlights The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) released its key conclusions from the January 2026 meeting, announcing the recommendation of six new medicines for marketing authorization in the European Union. The decisions illustrate the EMA’s ongoing effort to expand access to innovative therapies while…
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CHMP January 2026 Highlights: Six Medicines Recommended for Approval
Overview of CHMP January 2026 Highlights The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded its January 26–29, 2026 meeting with a landmark outcome: six medicines were recommended for approval. This decision, if adopted by the European Commission, would bring new therapies to patients across a range of conditions. The CHMP…
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CHMP January 2026 Highlights: Six Medicines Recommended for Approval by EMA
Overview: CHMP’s January 2026 decision highlights The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded its January 2026 session by recommending six medicines for marketing authorization in the European Union. This marks a significant moment for patients awaiting new therapies, as well as for the biotech and pharmaceutical industries focused on…
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EMA ETF Improves Scientific Advice for Medicines and Vaccines Tackling Public Health Threats
Background: A New Era for Public Health Medicines The European Medicines Agency’s Emergency Task Force (ETF) is reforming how it provides scientific advice to developers working on medicines and vaccines for urgent public health threats. This initiative aims to streamline the path from early development to clinical evidence, with a particular focus on antimicrobial resistance…
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EMA ETF Refines Scientific Advice for Antimicrobial Resistance Medicines and Public Health Threats
Enhancing Guidance for Medicines in Public Health Emergencies The European Medicines Agency’s (EMA) Emergency Task Force (ETF) is upgrading its approach to providing scientific advice for the most promising medicines and vaccines in development to combat public health threats. This evolution focuses on ensuring that life-saving therapies are developed with robust regulatory input, especially in…
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Improved Scientific Advice for Medicines Tackling Public Health Threats, Including Antimicrobial Resistance
Raising the Bar for Medicines and Vaccines against Public Health Threats Public health threats evolve rapidly, from novel pathogens to the growing challenge of antimicrobial resistance (AMR). In response, the European Medicines Agency’s Emergency Task Force (ETF) is refining its approach to provide higher-quality, earlier scientific advice for medicines and vaccines under development. The aim…
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Wiskott-Aldrich Gene Therapy: EU EMA Recommends Waskyra for WAS
What is Wiskott-Aldrich syndrome and the promise of gene therapy Wiskott-Aldrich syndrome (WAS) is a rare, inherited immune disorder caused by mutations in the WAS gene. The condition typically presents in infancy or early childhood with a mix of immune dysfunction, small blood cells (thrombocytopenia), eczema, and an increased risk of infections and autoimmune problems.…
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First EU Approval Consideration for WAS Gene Therapy: Waskyra (etuvetidigene autotemcel)
What is Waskyra and Who Could Benefit? The European Medicines Agency (EMA) has recommended granting marketing authorisation in the European Union for Waskyra (etuvetidigene autotemcel) to treat people aged 6 months and older with Wiskott-Aldrich syndrome (WAS) who carry a mutation in the WAS gene. Waskyra is a one-time, autologous gene therapy that aims to…