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.

The vaccine has saved 94 million lives – but measles is spreading again

A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...

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...

Mercodia AB

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...

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.

One System, Three Contrasting Techniques

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

Discover Precision: Join ZEISS at the Control Fair in Stuttgart

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

The Future of Metrology is Coming to Your Region

Join our event series.

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.

Meet us at Control 2025

Innovations that drive efficiency.

ZEISS supports the transition of spatial biology to clinical research

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

Hon får tungt uppdrag i Astra Zeneca – ersätter frihetsberövad Kinachef

Astra Zeneca utser Iskra Reic till Executive Vice President (EVP), International. Det betyder att hon får ansvar för bolagets övergripande strategi i stora dela...

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