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European Medicines Agency

Pharma & Biotech

Why Novartis Pharma AG’s Itvisma could redefine treatment pathways for older SMA patients

Novartis Pharma AG’s Itvisma gains CHMP support in SMA. Find out how gene therapy could reshape treatment for older patients in Europe.

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Pharma & Biotech

How Novo Nordisk may be lowering one of the biggest operational barriers in GLP-1 distribution

Read how Novo Nordisk may be reducing one of the biggest GLP-1 delivery barriers in Europe and what it could mean for Wegovy’s market expansion.

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Pharma & Biotech

Can Abbisko Therapeutics turn irpagratinib into the first approved FGFR4 therapy for hepatocellular carcinoma?

Abbisko Therapeutics won EMA orphan drug designation for irpagratinib in liver cancer. Read what this changes for FGFR4-targeted therapy.

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Pharma & Biotech

Why MaaT Pharma’s MaaT013 survival signal could reshape refractory GI-aGvHD treatment debate

MaaT Pharma’s MaaT013 posted pivotal Phase 3 GI-aGvHD data. Read what it could mean for EMA approval, adoption, and microbiome therapeutics.

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Pharma & Biotech

What PolTREG-T1D reveals about the future of cell therapy in autoimmune diseases

PolTREG advances its TREG cell therapy for type 1 diabetes toward EU approval. Learn what this milestone means for autoimmune disease treatment.

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Pharma & Biotech

Foresee Pharmaceuticals wins CHMP backing for CAMCEVI 21 mg, expanding prostate cancer treatment options in Europe

CHMP backs CAMCEVI 21 mg for advanced prostate cancer in the EU. Discover what the decision means for androgen deprivation therapy and oncology markets.

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Pharma & Biotech

Can Acadia overturn EMA’s negative opinion on trofinetide for Rett syndrome?

Acadia seeks EU re-examination after CHMP rejects trofinetide for Rett syndrome. Read the regulatory and clinical implications.

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Pharma & Biotech

Ipsen moves closer to EU approval for Ojemda in BRAF-driven childhood brain tumors

Ipsen nears EU approval for Ojemda in BRAF-driven pediatric glioma. Explore regulatory impact, clinical implications, and long-term risks.

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Pharma & Biotech

Can X4 Pharmaceuticals and Norgine unlock EU access to the first targeted WHIM therapy?

EMA backs mavorixafor for WHIM syndrome. Explore what EU approval could mean for access, evidence standards, and rare immunology treatment.

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Pharma & Biotech

Novo Nordisk secures EU nod for higher Wegovy dose amid intensifying GLP-1 competition

EU approves 7.2 mg Wegovy for obesity. Explore what this means for efficacy, competition and reimbursement across Europe.

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