Voucher application details focus on AUD as a major driver of the U.S. substance use crisis and the genetic targeting of AD04 ...

The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with ...

Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG ("Araris") today announced that the U.S. Food and Drug Administration (FDA) has completed its Investigational New Drug (IND) ...

The FDA has taken a significant step in advancing implementation of real-time clinical trials (RTCT).

The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical ...

Rare disease research operates under conditions of extreme complexity. These pressures are driving new approaches to evidence ...

Over the past several years, pharmaceutical companies have been steadily integrating artificial intelligence (AI) into many aspects of clinical development. Today, AI’s impact is being felt from the ...

An FDA initiative to implement real-world clinical trials could dramatically accelerate the pace at which new treatments ...

Thanks to new regulatory frameworks like the Food and Drug Administration’s Breakthrough Therapy designation, drugs are coming to market faster than ever. A 2024 analysis of drugs included in this ...

PALO ALTO, Calif.--(BUSINESS WIRE)--Science Exchange, the leading SaaS provider of supplier orchestration solutions for the life sciences industry, today announced the launch of its Clinical ...

Leda Mannent, MD, global project head, Immunology and Inflammation, Sanofi, outlines future steps for the clinical development of rilzabrutinib, as well as promising data to advance to phase 3 studies ...