FDA’s draft guidance allows sponsors to leverage public and platform knowledge for CMC, nonclinical, and clinical support of ...

Guidance shows how sponsors can build on existing science, reducing redundant testing and accelerating treatments for ...

Scientists have developed a powerful new technique that allows them to observe how individual cells manufacture proteins ...

After losing her cat Chai, an Austin woman spent $25,000 on pet cloning. Four years later, she met Belle and learned what ...

Sponsors are expected to justify relevance and applicability when relying on prior CMC, nonclinical, or clinical information to increase review efficiency. Platform knowledge can derive from internal ...

Highlights from the last week of May, 2026: A key climate tipping point is disrupting the Arctic Ocean food chain (more of a lowlight, I guess). Scuba-diving tourism may not be the benefit to coral ...

A new study discovers a non-repeating genomic master clock led by MYRF-1 and LIN-42 that drives cellular development.

A small fish that lives fast and dies young has given biologists a rare look at one of evolution’s oldest bargains. In the ...

Thick, red patches of skin with silvery scales (called plaques) on the elbows, knees, scalp, and sometimes the lower back are ...

Cost should not be the principal factor guiding choice of calf nutrition, but it is certainly influential. At a breakeven ...

A study led by researchers at the Universitat Autònoma de Barcelona (UAB) and the Josep Carreras Leukemia Research Institute ...