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.

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...

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...

A cluster contribution to European life science innovation and competitiveness?

Del 4 i Advance serien: Produkter och system

Vi uppfyller dina specifika krav när standardlösningar inte räcker till.

Roche joins Medicon Village

Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...

FDA approves Gilead’s HIV injection: “Historic day”

Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

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...

The New Precise Magazine is Available Now

Download the new issue.

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...

ZEISS unveils AI-powered Research Data Platform

Collaboration with Boehringer Ingelheim champions the future of personalized eye care.

Many discontinue obesity medication – new study highlights the reasons

A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...

In search of Marcel Proust's lost health

A great writer, but also a weak person and a hypochondriac. That has been the usual image of Marcel Proust. But the pediatrician and literary scholar Carl Lindg...

Pulsen på patientförbunden del 4: Ung Cancer

”Engagemang och vilja finns, det gäller bara att hitta rätt former”, säger Therese Leijon, Ung Cancer, i Life Science Swedens artikelserie Pulsen på patientförbunden.

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 ...

Medical Plastics Tips & Tricks

Measuringhero video by ZEISS.

Avhopp i Kennedys vaccinkommitté inför första mötet

Efter att ha sparkat samtliga experter i USA:s vaccinkommitté och tillsatt åtta nya, står hälsominister Robert F. Kennedy Jr. nu med en ofullständig panel. En m...

Organize and Manage Digital Classrooms

Create engaging lessons with ZEISS Labscope Teacher.

Optimera flödeshanteringen med Brooks Expert Support Tool (BEST)

Brooks Instrument erbjuder ett kraftfullt verktyg för dig som arbetar med digitala massflödesmätare och massflödesregulatorer. Med den Windows-baserade mjukvara...

RegSmart Life Science AB

New drug to simplify treatment of hemophilia

A new type of treatment for hemophilia, which only needs to be administered every two months, has been approved by the U.S. Food and Drug Administration (FDA).

Scientific Solutions

Trender inom life science 2025 – Del 4 neuro

Nya alzheimerläkemedel börjar användas, ett nytt MS-läkemedel gör entré och verktyg för att ta aktiva substanser genom blod-hjärnbarriären utvecklas. Dessutom v...