Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.

The emergence of AI and biosensors offers a chance to address inefficiencies in drug development.

Angela Zubel, chief development officer, Debiopharm, discusses why 2026 marks a shift from AI pilots to broader operational ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

The guidance encourages the use of Bayesian statistics in drug trials. Instead of starting from scratch and only adding new ...

The pharmaceutical industry is experiencing its own “DeepSeek moment,” according to science writer Hiya Jain. Just as the upstart AI breakthrough caught Silicon Valley off-guard, China is emerging as ...

Soo-Kyung and Jae Lee, whose daughter has FOXG1 syndrome, developed gene therapy that could one day treat people with this ...

Minimal residual disease (MRD) refers to the small number of myeloma cells that may remain after treatment and are not detectable using conventional response criteria. In multiple myeloma, MRD ...