The Division of Policy Development in the Office of Generic Drug Policy, which was created more than a decade ago, was ...

The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.

Commissioner Robert Califf said the federal agency that he’s known for years “is finished” after mass layoffs began Tuesday ...

AFP via Getty Images Marks’ resignation comes about two months after the exit of Patrizia Cavazzoni, the head of FDA’s drug evaluation unit. Neither Marks nor representatives from the HHS ...

Key to 400-employee Denali's submission is the FDA allowing measurement of a type of GAG, called heparan sulfate, in ...

Michael Moye, President and General Manager of Idorsia US, commented: “The fact that the FDA has expedited the approval of the updated TRYVIO label to remove the REMS requirements is, I believe, a ...