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Regulatory

FDA Building American - Drug Approvals

FDA Drug Approval Decisions to Watch: July and August 2026

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Illustration of a subcutaneous autoinjector beside a kidney icon, representing FDA approval of Trutakna for IgA nephropathy.

Atacicept FDA Approval: Trutakna Cleared for IgAN

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Three layered cards symbolise connected medical devices with a heart monitor line and a security checkmark

CE Marking Is Not Enough: Three Layers for Connected Medical Devices

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Kidney cross-section illustration next to a 7 Jul calendar and review stamp: atacicept IgA nephropathy FDA decision.

Atacicept IgA Nephropathy: FDA Decision Due 7 July

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Lab worker holds a labelled vial for FDA accelerated approval review, with FDA signage visible in a sterile lab zone

FDA Accelerated Approval: How the Fast-Track Pathway Works

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AI governance framework diagram projected in a biopharma laboratory as scientists work at illuminated benches

AI Governance in Biopharma Is Failing the Translation Test

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Glowing neural network nodes and data connections illustrating AI transparency in SaMD regulation

AI Transparency Gap in SaMD Regulation

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3D map of Europe with glowing network nodes showing fragmented EU IVDR precision oncology regulatory connections

Why Europe’s Precision Oncology Trials Keep Stalling

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GSK and Nuvalent drug candidates zidesamtinib and neladalkib for non-small cell lung cancer targeted therapy

GSK’s $10.6 Billion Nuvalent Deal: Reshaping the Lung Cancer Drug Race

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Nurse in blue scrubs sitting alone on a hospital corridor floor, head down, depicting the emotional toll of workplace bullying in healthcare

The Silent Epidemic: Workplace Bullying in Healthcare

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A biosimilar medication vial in focus in the foreground alongside an originator biologic vial and a regulatory approval document on a clinical white laboratory surface.

Biosimilar Approvals 2026: What’s Approved and What’s Next

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speaker talking about FDA drug approvals

Trump FDA Drug Approvals: Global Impact

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