Short Summary The EU, UK, and USA each have distinct and evolving regulatory systems for medicines and medical devices, involving strict approval, surveillance, and market access requirements managed ...

Obesity alters how medications work, increasing the risk of underdosing, overdosing, and unknown interactions. Are package ...

The FDA granted the “breakthrough device” designation to the research group’s Damo Panda model, allowing for an expedited review and approval ... Damo Panda in trials across China, the ...

In the fifth episode of a six-part interview series on immunotherapy, Marc Voigt, CEO and Executive Director of Immutep (ASX:IMM), explains the complex and heavily regulated process of bringing a new ...

Majority Democrats adopted a second measure Tuesday over Republican objections that would gradually phase out property taxes ...

Trials are used to test potential medicines, treatments or procedures. The National Institutes for Health define a clinical ...

Chico, Vice President and Global Head of Oncology Therapeutic Expertise at Fortrea, shares how scientific advances, AI tools and flexible CRO models are accelerating oncology trials and improving ...

The FDA announced it will be reducing, refining and potentially replacing the animal testing requirement for the approval of ...

Therefore, for public sites, HREC and an SSA is required for a clinical trial to commence. The most common approval process for clinical trials using unapproved medicines in Australia is via the ...

Mangoceuticals Inc. (NASDAQ:MGRX) is on a mission to rewrite the playbook for men’s performance, health, and vitality. Its pursuit comes at a time when opportunities have become enormous, with patent ...

Deficiency of the PMM2 enzyme stems from PMM2 gene mutations that disrupt glycosylation, the process in which sugar ... goal of the placebo-controlled clinical trial. But after six months, those ...