Sarepta said it accepts the CHMP decision on Elevidys, while partner Roche said it will continue working with the EMA.

The clinical trial industry has long recognized the importance of standardization in driving efficiency and ensuring data quality. Efforts ...

In today’s tech-driven landscape, it seems like every software solution in the clinical industry needs to have some AI ...

The UK and India’s new £4.8bn free trade agreement (FTA) is expected to allow new opportunities for Indian medical device and pharmaceutical manufacturers.

Growing budgetary pressure is a central theme in France as it prepares for the publication of the government's 2026 Social Security Finance Bill (PLFSS).

A federal district court in Delaware ruled that Viatris’ product, currently awaiting approval from the US Food and Drug Administration (FDA), does not infringe on Novo Nordisk’s patent for the ...

In 2025, Turbine took the first steps in opening its powerful cell simulation platform to the wider drug development ...

Ultragenyx Pharmaceuticals has announced the extension of approval by Health Canada for Evkeeza (evinacumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering ...

Fangzhou has signed a MoU with Novo Nordisk to collaborate on the management of serious chronic diseases, including obesity and diabetes.

The EC has approved Janssen-Cilag International’s new indication for Darzalex Faspro (daratumumab) to treat adults with SMM.

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.