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.

LINK Medical recruits Swedish CEO

The Norwegian Contract Research Organization LINK Medical has recruited Anders Göransson as the new CEO.

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...

Lista: Årets mest framstående medicinska uppfinningar

Den subkutana formen av det svenskutvecklade alzheimerläkemedlet Leqembi lyfts fram när Time presenterar sin årliga lista över de bästa uppfinningarna 2025.

Första svenska patienten behandlad med Carvykti – ”Gått som planerat”

För första gången har en svensk patient behandlats med Carvykti, en CAR-T-cellterapi mot blodcancerformen multipelt myelom. Bakom behandlingen ligger flera års ...

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...

Several departures at the top at Nykode

Members of both the management and the board are leaving the Norwegian biotech company Nykode.

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...

Aqilion's licensing journey: From Merck partnership to new opportunities

Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...

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...

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 ...

A+ Science AB

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 showcases expansion of ophthalmic care options creating industry-leading workflow solutions

ZEISS Medical Technology will showcase new ophthalmic innovations and market milestones at ESCRS 2025 in Copenhagen.

Bioscience – Groundbreaking Research & Diagnostics: Stockholm (2025)

ZEISS continues to drive digital era forward in ophthalmology

2 million digitally planned cataract cases in the U.S. alone.

GSK acquires oncology research company

GSK acquires the American biotechnology company Idrx for up to 1.15 billion dollars.

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. ...

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...

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.

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

Scientific Solutions

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...