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.

Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...

Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.

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 ...

Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to treat Type 2 diabetes. Some doctors also prescribe Mounjaro "off-label" for ...

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

One practice now under greater scrutiny is health care insurers’ use of artificial intelligence (AI) algorithms to deny ...

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, ...