“Together with the recent FDA approval and late-breaking NATALEE data ... NATALEE is a global phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali ...

Novartis said the European Medicines Agency has recommended its Kisqali cancer drug for market authorization. The drugmaker said Friday that the EMA's Committee for Medicinal Products for Human ...

The FDA updated GLP-1 drug labels to warn of the risk of patients breathing food into their lungs while under anesthesia for ...

Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...

Novartis looks odds on to extend the indications of its CDK4/6 inhibitor Kisqali into ... on Ki-67 levels. The drug made $2.5 billion in sales last year, and its label was extended in March ...

For those patients, there have been some rare cases of pulmonary aspiration — or inhaling fluid or food into the lungs — while under anesthesia, according to the new FDA label. It’s not yet ...

Costco recalls Kirkland butter over an unlabeled allergen. Learn why accurate food labeling is crucial for consumer trust and how to respond if you’re affected.

This is the first gene therapy for AADC deficiency to receive US regulatory approval and the first that can be administered directly to the brain.

EAST HANOVER, N.J., Oct. 18, 2024 /PRNewswire/ -- Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a ...

Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA) recommended granting approval to the breast cancer drug Kisqali ...