For the first time since it launched in 2020 and began accepting submissions in 2022, a program started by the FDA to provide support for unconventional drug development tools has accepted its first ...

Categorizing patients with cancer by their disease stage can be an important tool when conducting administrative claims-based studies. As claims databases frequently do not capture this information, ...

The biopharmaceutical industry stands on the cusp of a revolution, with artificial intelligence (AI) emerging as a transformative force in drug development. AI's ability to reduce the time and cost of ...

The FDA has qualified AI-Based Histologic Measurement of MASH, or AIM-MASH AI Assist — the first AI drug development tool — ...

SAN DIEGO and SUZHOU, China, July 15, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based ...

Bari Kowal, Senior Vice President, Development Operations & Portfolio Management at Regeneron Clinical trial innovation is a hot topic, but it’s not a new one. The first fully virtual randomized trial ...

The Congressional Budget Office (CBO) informs Congress about the costs or revenue changes associated with proposed legislation, a challenging enough task on its own. Sometimes, the CBO is asked to ...

Drug discovery has traditionally been slow and expensive, often taking decades and costing manufacturers billions. Traditional methods, while advancing, are hitting limits in tackling the complexities ...

FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approval Company continues preparations for enabling ...

PONTE VEDRA, Fla.--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) today recapped its 2024 milestones and highlighted a clear path forward to develop the investigational drug tecarfarin as ...