In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

The Institute for the Advancement of Food & Nutrition Science publishes a list of general principles it hopes will inform any ...

As Hytale develops further in Early Access, developer Hypixel Studios has opened up about the future of world generation with ...

In today's healthcare environment, securing regulatory approval is only the beginning. The real challenge lies in ensuring ...

METR’s benchmark has become a bellwether of AI capability growth, but its design isn’t up to the task, argues Nathan Witkin ...

The head of the Department of Health and Human Services has spent decades promoting vaccine skepticism and has now revamped the US childhood immunization schedule to have one-third fewer recommended ...

This is interesting because DCC came out in the waning days of D&D’s 4e, which was disliked even more by players, but a ...

Objectives This scoping review addresses the underexplored issue of abuse of people with mental illnesses by healthcare ...

MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License ...