FDA Should Publish QT Prolongation Database, Industry Reps Say

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.