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.

Life science trends 2025 – Neurology

New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver active substances across the blood-...

“Conducting research at universities is becoming more and more like working at a research hotel”

The government wants Swedish research to focus on excellence and innovation, but can the two be combined? Life Science Sweden talks to Anna Falk, a professor at...

Discover ZEISS ZEN core – now for electron microscopy

Watch the recording of our free webinar.

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...

Lilly´s Nordic manager on Mounjaro launch in Sweden: "Patients deserve respect"

Another blockbuster diabetes and obesity drug has made its way into the Swedish market – with promises of a stable supply and availability for patients. “What w...

Medivir CEO on upcoming study: ”It's about working together with others”

Medivir is a small company with a big task: to take its drug candidate, via extensive clinical studies, all the way to a patient group that currently lacks appr...

The future of healthcare in focus: ”Together, things happen”

In march, it’s once again time for Fokus Patient, an event for the industry where the patients’ perspective takes center stage. It’s a great way to spread knowl...

Vaccine skeptic David Geier to lead study on link to autism

The American government is to launch a study on whether vaccines cause autism – and has appointed a well-known vaccine skeptic to lead the analysis.

AZ gets approval for drug targeting rare disease – it may reduce cortisone dependence

AstraZeneca’s drug Fasenra gets an expanded indication in the EU and is now approved as a treatment for the rare autoimmune disease known as Churg-Strauss syndrome.

Investment CEO: “The Nordics are outstanding in creating successful medtech companies”

Since the beginning of last month, Susanna Francke Rodau has been a partner and the new CEO of Segulah Medical Acceleration, which invests in medical technology...

Positive trend for Swedish medtech exports – “We have new markets that are huge”

In 2024, Swedish exports of pharmaceuticals decreased for the first time in several years. However, the trend for medical technology looks brighter. During a se...

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...

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...

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

Wegovy approved in the U.S. for treatment of liver disease

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novo Nordisk’s drug Wegovy to treat the serious liver condition known as MASH. ...

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...

Gene therapy restored hearing in children with congenital deafness

Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...

AI detects tumor disease – via voice recording

A short voice recording along with facial images – both analyzed with an AI algorithm – can make it possible to detect the rare tumour disease acromegaly and in...

Ny svängning – Trump hotar med 100-procentiga tullar på läkemedel

USA kommer att införa 100-procentiga tullar på importerade läkemedel, såvida inte bolagen bygger fabriker på amerikansk mark, uppger president Donald Trump.

Vaccine project targeting congenital infection scrapped in late-stage trial – “Clearly disappointed”

Hope for the first vaccine against the world’s most common congenital infection has taken a serious hit

Samuel Lagercrantz: “Companies that do this successfully will take the lead”

The development of new medicines and medical technologies should not focus too narrowly on prolonging life. It is equally important to develop treatments that r...

Sneak Peek of ZEISS Metrology Expert Tips Season 2

The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.

FDA approves new cystic fibrosis therapy

A new treatment for cystic fibrosis has been approved by the U.S. Food and Drug Administration (FDA).