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 ...

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

Plummeting trust in vaccines could be lethal on its own. But there are also ways Trump’s nominee for Health and Human ...

RFK Jr.’s anti-industry and anti-vaccine rhetoric has been strong, but experts wonder whether those words will turn into ...

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.

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

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

The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP) ...

Researchers used a scalable human liver microtissue model to accurately predict the drug-induced liver injury concern of 152 ...

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