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.

The Trump administration’s moves to shrink the federal workforce put the FDA’s ability to regulate drugs and oversee the ...

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

After the contentious Senate confirmation of Robert F. Kennedy Jr., another crucial governmental health leadership ...

U.S. Secretary of Health and Human Services Robert Kennedy Jr. directed the Food and Drug Administration on Monday to revise ...

FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...

President Donald Trump’s pick to lead the US Food and Drug Administration told senators in a tense confirmation hearing ...

New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...

President Donald Trump’s nominee for FDA Commissioner, Martin A. Makary, MD, sought to assure senators that if confirmed, he would support efforts to expedite reviews of new drugs indicted for rare ...

The Food and Drug Administration (FDA) is not likely to continue to review and approve human drugs or medical devices if the federal government ...