New non-primate draft guidance follows the FDA's wider aim to curtail the use of animal testing in preclinical toxicology.

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

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.

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

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

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

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 ...

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

The UK becomes the latest country in President Donald Trump’s long line of trade agreements, though it is the first region to ...

If approved, Regeneron and Tessera's TSRA-196 could become the first curative therapy to reach patients with AATD, who have ...

Eisai has submitted a new drug application to Japan’s PMDA seeking approval for Leqembi’s SC formulation, SC-AI, for early ...