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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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“Access to capital increases when there’s an exit”
It remains a tough environment for biotech companies seeking financing – but there is good reason to hope for improvement ahead. That’s the view of Okee William...
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A cluster contribution to European life science innovation and competitiveness?
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ZEISS EVO as the Key to Wire Technology in Modern Medicine
High-performance wires for stents.
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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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Shaping regulatory complexity into strategic clarity
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...
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PMS, Vigilance and Risk Management
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...
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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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How the Nobel discovery is used in drug development
Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...
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Southern Swedish company Aqilion develops drug for eosinophilic esophagitis
When Aqilion began developing a drug for eosinophilic esophagitis, the molecule was classified as an orphan drug. But the prevalence of the disease now appears ...
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Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”
Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...
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Swedish life science is growing – but capital is not keeping up
The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...
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Advanced workflow automation and scalable image analysis in spatial biology
ZEISS and Concept Life Sciences announce partnership.
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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, ...
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The Future of Metrology is Coming to Your Region
Join our event series.
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Swedish team tests Alzheimer antibody for brain imaging
Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...
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Experience innovations of the future
ZEISS QUALITY INNOVATIONS WORLDWIDE event in Oberkochen, Germany, January 20-21, 2026.
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Acne medication may be the solution when hair starts falling out
A treatment originally developed for acne has shown remarkable Phase III results in a completely different area: male-pattern hair loss.
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FDA launches investigation into gene therapy following child death
The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The...
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Shaping the Future of Metrology – Live in Your Region
Insights into our event series.
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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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Astra Zeneca pauses multi-million investment in the UK
Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.