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 ...

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

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

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

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

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

Whether or not telehealth companies are under FDA jurisdiction when marketing and promoting prescription drugs has been under ...

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.

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 ...

The Food and Drug Administration issued a warning Friday that advised consumers against inhaling nitrous oxide products such ...

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SYD-101 (atropine sulfate) to slow the progression of ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...