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.

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

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

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

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 ...

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 ...

A Trump executive order forming the commission tasked them with assessing the ‘threat posed by’ ADHD meds. Learn how experts ...

Paid Advertisement In a world where personal appearance is increasingly valued, skin blemishes such as moles and skin tags ...

Hemophilia is a rare, inherited disease that causes blood to not clot as it should and can cause spontaneous bleeding. Learn how this affects your prognosis.