In today’s ACT Brief, we examine how large de-identified datasets are reshaping trial design and site strategy, why global ...

In today’s ACT Brief, we explore why decentralized trial innovations struggle to scale without better change management, ...

FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

2026 will be the year that artificial intelligence accelerates multiple aspects of the drug discovery and development ...

The U.S. Food and Drug Administration (FDA) issued its third Patient-Focused Drug Development (PFDD) guidance titled, “Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments ...

NEWARK, DE — QPS Holdings, LLC has implemented Oracle Argus, a widely used pharmacovigilance platform, in a move aimed at strengthening patient safety oversight and regulatory compliance across its ...

UB researcher Murali Ramanathan has used artificial intelligence (AI) since its nascent days while exploring possible treatments for multiple sclerosis (MS) and Alzheimer’s disease. Today, Ramanathan, ...

Jan 14 (Reuters) - The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe ...

Strengthens clinical and regulatory guidance as PSX-001 advances to its next phase of development. MELBOURNE, Australia and NEW YORK, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Incannex He ...

Study in a Sentence: Cedars-Sinai researchers are developing KronosRx, an artificial intelligence-powered platform that uses human-derived organoids and deep-learning models to forecast adverse drug ...

Despite new methodologies and flexible regulatory pathways, CNS biopharmaceuticals still face significant safety assessment ...

Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, today announced that it has been honored with the Research and ...