Incyte INCY announced that the FDA has extended the review period for the supplemental new drug application (sNDA) for ...

NHS cost-effectiveness overseer NICE has published new guidance recommending IL-36 inhibitor Spevigo (spesolimab) for the ...

However, amid the broader macro uncertainty, the drug and biotech sector seems to have recovered in the past month, backed by ...

The label expansion comes three years after the FDA signed off on Nubeqa in combination ... With Nubeqa and kidney disease treatment Kerendia—which achieved an 89% increase in sales to 161 ...

Bayer BAYRY announced that the FDA has granted full approval ... The company is working to expand the labels of its key drugs, Nubeqa and Kerendia, which should boost growth.

Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for Kerendia (finerenone) to treat a new indication. The sNDA seeks ...

Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for Kerendia (finerenone) to treat a new indication. The sNDA seeks approval ...

accepted its supplemental new drug application (sNDA) and granted Priority Review designation for KERENDIA® (finerenone) for the treatment of adult patients with heart failure (HF) with a left ...

KERENDIA ® (finerenone) is the first non-steroidal ... particularly among those with comorbidities 3 The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would ...