The Food and Drug Administration (FDA) on Tuesday announced a new initiative titled “Operation Stork Speed” aimed at ...

Despite the Trump administration's shake-up of the agency, the US FDA is the first port of call for most ASX biotechs.

Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for ...

The US Food and Drug Administration (FDA) accepted and granted Priority Review designation for Bayer’s (BAYN: DE) supplemental new drug application (sNDA) for a new indication for Kerendia (finerenone ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of ...

The U.S. Health and Human Services Agency, along with the Food and Drug Administration, announced a new initiative Tuesday ...

The convergence of AI and drug delivery is opening new frontiers in precision medicine. AI-powered predictive modeling is ...

Investing.com -- The U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) unveiled a series of actions and programs on Tuesday, aimed at improving the quality, ...

Johnson & Johnson's nipocalimab earns FDA Fast Track status for Sjögren's disease, speeding development and review for unmet medical needs.

The U.S. Health and Human Services Secretary is pushing to end a rule that allows food companies to use additives that ...

If I thought there was a problem, I would have stated it in the paper,” Joseph Borzelleca, 94, a professor emeritus of ...

Company expects to have sufficient cash to fund planned operations beyond the FDA PDUFA goal date and anticipated fourth ...