The landmark move by the FDA for real-time clinical trials has overall been met with support by the industry.

The FDA’s real-time clinical trial mechanism allows drug sponsors to transmit data immediately to the regulator through the ...

This article reviews the scope, key principles, methodological expectations, and regulatory implications of ICH E20, and ...

Krystal Biotech leverages its HSV-1 gene delivery platform, with VYJUVEK generating strong cash flow. Read why I rate KRYS ...

Clinically meaningful improvements in xerostomia symptoms measured by PRO Xerostomia Questionnaire (XQ) maintained out to 3 years post treatment ...

Eirini Schlosser, CEO and founder of Dyania Health, discusses how the company's AI uses contextual reasoning to extract ...

Doctronic reports new AI analysis reveals GLP-1 medications may cause underreported symptoms like menstrual irregularities ...

Federal directives deploy priority review vouchers, earlier DEA rescheduling, and ARPA-H matching funds to compress ...

Liver transplant rejection significantly affects patient prognosis. Myeloid-derived suppressor cells (MDSCs), known for their ...

All of the studies had been financed by the federal government and carried out by scientists at the FDA. They had been ...

Clinical Trial Share -- BioLife products are used in over 250 commercially sponsored cell and gene therapy (CGT) clinical ...