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...

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 during treatment can be a heavy burden for both patients and healthcare systems. Dr. Andri...

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...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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...

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...

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...

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...

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 ...

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...

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...

A cluster contribution to European life science innovation and competitiveness?

ZEISS EVO as the Key to Wire Technology in Modern Medicine

High-performance wires for stents.

New findings on the diseases that crushed Napoleon’s army

As if cold, starvation, and typhus weren’t enough. New research reveals that Napoleon’s defeated army also suffered from paratyphoid fever and relapsing fever d...

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. ...

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...

New ATMP center inaugurated: “In the future, we will see cell and gene therapies in all clinics”

Karolinska Institutet and Karolinska University Hospital’s new ATMP center was inaugurated in Flemingsberg, south of Stockholm. “The ATMP Center is not just a p...

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.

Allogene discontinues investigational antibody following patient death

U.S. biotechnology company Allogene Therapeutics is fully discontinuing the use of its experimental antibody ALLO-647 following the death of a patient in its pivotal CAR-T trial....

IVDR Reality Check: Are We Moving Fast Enough?

As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA

ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.

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.

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 breaking the transmission...