The new document replaces an earlier draft guidance issued ... should be a comparison of the mean percentage change in body ...

Magdalena aiming to submit Investigational New Drug (IND) application in early 2025 to the FDA for a next-generation ...

Pluristyx Announces Immediate Availability of GMP-Compliant PSXi013 iPSC Line for Advanced Therapy Development ...

Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI) Ersodetug continues to advance in ...

Variant Bio, a small biotech company based in Seattle, is using genetic information from Indigenous people to develop drugs ...

GSK announced on Tuesday that its investigational antibody-drug conjugate GSK'227 has been granted breakthrough therapy ...

Researchers at the University of Oklahoma have developed a breakthrough method of adding a single nitrogen atom to molecules, ...

After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...

Because of the risks biopsies can pose to patients, the FDA recommends only requiring them as part of trial participation if ...