Life science marketing is changing, and with it our need for personalised engagement strategies. While omnichannel marketing ...

Regulators in the UK and US are the first to approve GSK's Exdensur, a long-acting, twice-yearly IL-5 inhibitor for severe asthma that has been billed as a major new product for the drugmaker. In the ...

The clinical research environment has undergone considerable transformation over the past decade. Protocols are more complex, product pipelines increasingly target smaller and more distributed patient ...

The FDA has published new guidance aimed at reducing or stopping toxicity studies of monoclonal antibody-based drugs in non-human primates (NHPs), in the latest stage of an ongoing effort to reduce ...

The next iteration of FDA user fees could see the charges for programmes that run clinical early-stage trials in the US fall, and rise for those in which studies are conducted abroad, in a bid to ...

The FDA has lost no time in approving the first drug under its recently launched Commissioner's National Priority Voucher (CNPV) programme, clearing an antibiotic manufactured in the US. The fast ...

Belite Bio has said the results of the DRAGON trial of its oral therapy for sight-robbing disorder Stargardt disease type 1 (STGD1), tinlarebant, could support an FDA filing. The San Diego biotech ...

A new care pathway has emerged in the United States, and patients are already using it every day. Direct-to-patient (DTP) platforms – defined as a digitally enabled, end-to-end treatment model in ...

Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead the agency's Center for Drug Evaluation and Research (CDER). Pazdur's departure – first ...

A real-world study exploring the long-term effects of Eli Lilly's weight-loss therapy tirzepatide in primary care settings has started in the UK. The five-year SURMOUNT-REAL UK trial, part of a ...

The UK government has confirmed that the rebate rate for newer medicines supplied to the NHS under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) will be 14.5% next year, ...

Johnson & Johnson's Imaavy has become the first FcRn blocker to be approved in the EU as a treatment for both adolescent and adult patients with generalised myasthenia gravis (gMG), taking on rivals ...