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

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

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.

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 ...

When Secretary of Health and Human Services Robert F. Kennedy, Jr. announced last week that he is directing the U.S. Food and ...

US Health and Human Services secretary Robert F. Kennedy Jr. directs the Food and Drug Administration to explore revamping ...

The Health and Human Services Secretary directed the FDA to consider eliminating a pathway that allowed companies to ...

Proposals to eliminate the self-affirmed GRAS pathway have sent shockwaves through the food industry. But what do they mean ...

Travere Therapeutics (TVTX) has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration seeking priority review ...

For decades, the U.S. Food and Drug Administration's GRAS rule has allowed untested additives into the food supply. Can RFK ...

Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.