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adaptive pathways

- PMLiVE

EMA celebrates diversity and inclusion in science and healthcare

The EU body underlines its commitment to diverse perspectives in medicines regulation

- PMLiVE

Astellas’ application to EMA validated for treatment of muscle-invasive bladder cancer

Bladder cancer affects over 224,000 people annually in Europe, with over 30% of cases being muscle-invasive bladder cancer

- PMLiVE

EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

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NEW WEBINAR: Maximizing Speed-to-Outcome for Life Science Companies

Stop losing momentum to the "logistics lag." The most successful life science teams have moved beyond fragmented spreadsheets and isolated meetings into a unified orchestration engine. Learn the strategies that...

Impetus Digital

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EMA reaffirms guidance on paracetamol use during pregnancy

The guidance follows recent US comments about a possible link to autism

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Johnson & Johnson seeks first EMA approval for icotrokinra for plaque psoriasis

Icotrokinra is a first-in-class, once-daily tablet for moderate-to-severe plaque psoriasis

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ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs

On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation...

Genesis Research Group

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EMA orphan drug designation given to ReAlta for graft-versus-host disease therapy

This follows preliminary results from the company's ongoing phase 2 trial

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Insights From ISPOR 2025: R In Health Technology Assessment – Is It The Future?

ISPOR’s annual meeting in Montreal this May was packed with opportunities to explore the latest trends, insights, and research in HEOR and market access. In this series, our experts share...

Petauri Evidence

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Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

The reference medicine holds approvals for multiple HER2-positive breast cancer indications

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Your essential guide to the World EPA Congress 2025: Top sessions and pre-reading

The World EPA organisers have curated an exceptional programme featuring thought-provoking presentations and dynamic panel sessions led by industry leaders driving market access strategy and practice. Following the opening keynote...

Petauri Evidence

Biogen Idec building

Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA

The neuromuscular disease affects approximately one in every 10,000 babies worldwide

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