FDA launches investigation into gene therapy following child death

The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The...

Southern Swedish company Aqilion develops drug for eosinophilic esophagitis

When Aqilion began developing a drug for eosinophilic esophagitis, the molecule was classified as an orphan drug. But the prevalence of the disease now appears ...

Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

The scientist behind Novo Nordisk's obesity success: “I never stopped believing in GLP-1”

the game," says Lotte Bjerre Knudsen, Chief Scientific Advisor at Novo Nordisk.

Shaping regulatory complexity into strategic clarity

As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...

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.

Webinar: Can AI replace humans in pharmacovigilance?

The webinar will explore how AI can transform pharmacovigilance by enhancing efficiency, reducing errors, and addressing challenges such as software costs, data security, and regulatory gaps....

BMS and venture capital giant form new company

The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...

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.

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...

Mercodia AB

Health politician Lina Nordquist: ”I find it hard to be idle”

She is the pharmacist and researcher who grew tired of the breakthroughs that never materialised and knowledge that never seemed to reach patients, so she decid...

FDA approves new cystic fibrosis therapy

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

Large study: The benefits and risks of obesity medications

Medications such as Ozempic can reduce the risk of a range of different diseases and health conditions but also increase the risk of others. This is according t...

Orexo får USA-stöd för överdosläkemedel vid blandmissbruk

Uppsalabolaget Orexo har fått 8 miljoner dollar, motsvarande 75 miljoner kronor, av den amerikanska myndigheten Barda för att ta fram ett nasalt räddningsläkeme...

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

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...

“Research is always a lot of failures and a few successes”

Gene therapies open up fantastic possibilities, but they are also extremely expensive to produce. Genenova aims to change that and make the treatments accessibl...

Canada approves leqembi as global alzheimer’s drug race heats up

Leqembi has secured approval in Canada, further consolidating its global lead among disease-modifying Alzheimer’s therapies. The antibody is now authorized in 1...

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...

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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...

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...

Genmab drops another ADC candidate from billion‑dollar ProfoundBio deal

Danish biotech Genmab has discontinued development of its antibody‑drug conjugate (ADC) candidate GEN1160, citing low patient enrollment in an early‑stage cancer trial.