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 ...

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 ...

If confirmed as the HHS Secretary by the US Senate, RFK Jr will oversee federal agencies that dictate healthcare policy in ...

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

The rise of antibody therapeutics is transforming drug discovery, providing highly specific treatments for complex diseases ...

AN2 Therapeutics said it was planning to meet with the U.S. Food and Drug Administration to discuss a development path for ... End-of-Phase 2 meeting with the FDA in the first half of next year ...