HealthCare Pharmaceuticals was granted FDA orphan designation for a treatment of non-small cell lung cancer harboring epidermal ...

Bayer and Merck & Co have won a breakthrough device designation from the US regulator FDA for artificial intelligence software they are jointly developing. The CTEPH Pattern Recognition Artificial ...

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 ...

Berlin: Bayer has announced that the Company has received Priority Review designation from the U.S. Food and Drug ...

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.

and the designation shortens the review period. German drugs-to-crops giant Bayer said about 6.7 million adults in the U.S. live with heart failure, with roughly 55% having mildly reduced or ...