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

Johnson & Johnson's nipocalimab receives FDA Fast Track status for Sjögren's disease, following strong Phase 2 trial results on disease activity and IgG reduction.

Studies have indicated that psychedelic drugs, such as psilocybin and MDMA, have swift-acting and enduring antidepressant effects. Though the US Food and Drug Administration denied the first ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. Food and Drug Administration, FDA, has accepted a 351(k) Biologic ...

Q4 2024 Earnings Call Transcript March 17, 2025 Protalix BioTherapeutics, Inc. beats earnings expectations. Reported EPS is $0.09, expectations were $0.07. Operator: Good morning, ladies and gentlemen ...

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 ...

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.