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Will the FDA’s new transparency policy extend to medical devices? (Part 1)

In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...

Alvotech nobbas i USA efter brister i fabrik – dyker på börsen

Isländska Alvotech, noterade på Stockholmsbörsen, har fått ett bakslag i sin lansering av biosimilaren AVT05 i USA, en kandidat som ska motsvara läkemedlet Simponi (golimumab).

Swedish team tests Alzheimer antibody for brain imaging

Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...

Xbrane backar efter ny FDA-smäll – ”Vi är mycket besvikna”

Xbrane Biopharma backar med över 30 procent på börsen efter fortsatta problem hos en kontraktstillverkare – vilket väntas leda till ytterligare förseningar av e...

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...

ZEISS Smartzoom 100 for Inspection Efficiency

Catch up on our free webinar.

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

Phase III win for Hansa Biopharma: “We Are Thrilled”

Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.

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.

ZEISS Lightfield 4D for instant volumetric high-speed imaging

Capturing physiological and neuronal processes in 3D.

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

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...

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?

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.

Discover ZEISS ZEN core – now for electron microscopy

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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...

Problem hos kontraktstillverkare stoppar Regenerons blodcancerläkemedel

För andra gången har Regeneron nekats godkännande i USA för en ny lymfombehandling. Orsaken uppges denna gång vara anmärkningar mot en extern tillverkningsanläg...

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...

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 ...

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)