New non-primate draft guidance follows the FDA's wider aim to curtail the use of animal testing in preclinical toxicology.

The World Health Organization (WHO) predicts that fewer than 10% of eligible patients will have access to GLP-1RAs by 2030.

Rare disease research faces complex regulations, small patient populations, and high costs. As traditional incentives wane, new FDA guidance and family-friendly trial design will be essential to ...

Patient advocacy and industry bodies welcomed the bill’s backing, though it will now need to be passed in the Senate.

Biotechs in the charter city of Próspera aim to cure ageing, but experts question the feasibility of their goals.

Data management in oncology clinical trials features multiple complexities, and choosing the right EDC system is essential.

Solid Biosciences has secured US FDA rare paediatric disease designation for SGT-212, its investigational gene therapy targeting FA.

As 2026 approaches, rising complexity, geopolitical pressures and new modalities are reshaping strategy, capacity and CDMO ...

With $1.5 billion in drug sales, the US dominated the CKD-HPT, HP and HK market in 2024, representing 59.7% of 7MM sales.

The once-daily eye drop was observed to be generally well tolerated. Credit: megaflop/Shutterstock.com. Lotus Pharmaceutical ...