FDA’s new CSA guidance: transforming software validation for production and quality systems

FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.

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...

Clinigen Clinical Supplies Management GmbH

Heart Monitoring in Breast Cancer – Essential or Excessive?

Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...

Astra Zeneca’s asthma drug nears approval for sinus inflammation

Astra Zeneca’s drug Tezspire receives positive opinion from the European Medicines Agency (EMA) for the treatment of chronic rhinosinusitis with nasal polyps.

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

Pharma Outsourcing – Find the Right Partner (2025)

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...

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...

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...

Mercodia AB

Discover Precision: Join ZEISS at the Control Fair in Stuttgart

May 6-9, 2025 in Stuttgart. Hall 9, Booth 9309.

One System, Three Contrasting Techniques

ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.

Eli Lilly requests re-examination of Alzheimer's drug recommendation

Eli Lilly has requested that the EMA re-examine its opinion on the company's Alzheimer's drug, Kisunla, the agency announced on Friday.

The Future of Metrology is Coming to Your Region

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New moves around Nykode's management – withdrawal of resignations

Norwegian Nykode Therapeutics is reinstating members of the management team who previously announced their resignations.

Del 4 i Advance serien: Produkter och system

Vi uppfyller dina specifika krav när standardlösningar inte räcker till.

ZEISS supports the transition of spatial biology to clinical research

Slide scanner ZEISS Axioscan 7 spatial biology provides scalable workflow automation.

ZEISS Quality Innovations at CONTROL

May 6-9, 2025 in Stuttgart.

The dock that “thinks” for itself

The world of bulk material handling seems straightforward at first glance: moving, filling, delivering. However, the art of dealing with a variety of different ...

The Top 10 Challenges Facing Laboratories Today

Navigating the Laboratory Automation Landscape

Fast Optical Sectioning of Developing Organisms and Tissue Microstructures

ZEISS Lattice SIM 3 exploits the full potential of the SIM Apotome technology.

Novo Nordisk tells staff to return to office

At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...