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 ...

FDA has granted CLPH-511 Fast Track Designation for the treatment of acute hemorrhage as an alternative to conventional ...

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 ...

All of this echoed the position taken by Health and Human Services Secretary Robert F. Kennedy Jr. during his confirmation hearings, where he said that Trump had asked him to “review the data” on the ...

FILSPARI REMS: Due to the risk of hepatotoxicity and embryo-fetal toxicity, FILSPARI is available only through a restricted program called the FILSPARI REMS. Prescribers, patients, and pharmacies must ...

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

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