The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...

Mark Hahn and I discuss the critical vulnerabilities in the U.S. drug supply from Hurricanes Helene and Milton.

The FDA’s existing drug development protocol was not designed for increasingly ... A collaborative drug development approach ...

Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...

Lyophilization plays a crucial role in successful biologic molecule development, but what is lyophilization – and how can it ...

AN2 Therapeutics said it was planning to meet with the U.S. Food and Drug ... a development path for epetraborole, a treatment of non-tuberculous mycobacterial lung disease. The company said it will ...

The integration of AI into drug submission and approval processes signifies a shift towards more efficient pharmaceutical development. The potential benefits are substantial, including faster ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

RFK Jr., a longtime anti-vaccine activist, to play a role in Trump administration and potentially influence how the FDA and ...

From repealing climate policies to overturning guidance on the safe development of artificial intelligence (AI ... But under ...

Amber Hill spent 14 years as a medical researcher. She didn't mind the work, but there was one thing she consistently hated: ...

FELIQS plans to conduct a Phase 1b/2 study of FLQ-101 (tROPhy-1 study) both in the US and Japan in the first quarter of 2025.