The FDA has issued final guidance clarifying how prescription drug manufacturers should address companion apps and software in product labelling and regulatory submissions.

The UK's Medicines and Healthcare products Regulatory Agency has launched its 2030 strategy to modernise regulation of AI-enabled healthcare, medical devices and personalised medicines.

The UK government has accepted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare, moving its proposed framework into implementation.

The Council has formally adopted its position on the EU pharmaceutical package, moving the bloc's largest overhaul of medicines legislation in decades toward its final legislative stages.

EU pharmaceutical legislation has moved closer to completion after member states backed the Council's first-reading positions on the regulation and directive forming the bloc's revised medicines framework.

Zealand Pharma and Roche have started the global Phase 3 ZUPREME programme evaluating once-weekly petrelintide as a treatment for people with overweight or obesity.

Flow Neuroscience has launched FL-100 in the United States, bringing an FDA-approved at-home transcranial direct-current stimulation treatment to adults with moderate-to-severe major depressive disorder.

The European Medicines Agency has opened consultation on a draft guideline addressing the design and interpretation of studies assessing drug absorption interactions within the gastrointestinal tract.

Proteomics International has begun the controlled commercial rollout of its PromarkerD and PromarkerEso blood tests in Western Australia and the Northern Territory through its exclusive pathology distribution agreement with Healius.

CordenPharma is investing €80 million to expand aseptic fill-finish operations at its Caponago site in Italy, increasing projected sterile injectable capacity to up to 500 million units annually.

A UK national commission has proposed a new regulatory framework for artificial intelligence in healthcare designed to support faster adoption while maintaining safety, accountability and public trust.

GENFIT says its MASH diagnostics technology could support more than $1.5 billion in peak US sales by 2033 as the market for non-invasive patient identification expands.

BRAIN Biotech has received an €11.51 million milestone payment from Royalty Pharma linked to development progress for deucrictibant.

Novartis reports that the Phase III HARBOR study of del-desiran did not meet its primary endpoint in patients with myotonic dystrophy type 1.

Novartis reports that the Phase III Lp(a)HORIZON study of pelacarsen did not meet its primary cardiovascular endpoint in patients with elevated lipoprotein(a) and established cardiovascular disease.

Novartis India is looking at therapy-aligned acquisition opportunities while seeking to deepen its presence in India's Tier 2 and Tier 3 markets.

Qualcomm and ASUS have launched an on-premises AI assistant programme for community pharmacies across southern Taiwan.

TScan Therapeutics is cutting approximately 75% of its workforce and pausing further enrolment in its Phase 3 ALLOHA-2 study as it redirects resources towards in vivo cell therapy programmes for solid tumours.

Renalytix has signed a multi-year agreement with Quest Diagnostics to expand US access to its kidneyintelX.dkd blood test for patients with type 2 diabetes and chronic kidney disease.

Novacyt and Illumina have entered into a five-year master collaboration agreement to explore molecular-diagnostics product development and commercial opportunities.