Novartis, meanwhile, is also looking to muscle in on the adjuvant setting with the NATALEE trial of Kisqali, due to generate results later this year. The CDK 4/6 drug made $1.2 billion in sales ...

From STAT’s Elaine Chen: Earlier this month, the FDA updated the labels of GLP-1 drugs to warn of the risk of patients ...

“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 ...

The FDA recently expanded the approval of the breast cancer drug Kisqali to treat patients with earlier stages of the disease. Thousands of women diagnosed with early-stage breast cancer will have ...

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 ...

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 ...

The U.S. Food and Drug Administration ( FDA) has classified the recall of a brand of ice cream as Class II after it was ...

On November 5, the US Food and Drug Administration (FDA) updated the labels for all glucagon-like peptide 1 receptor agonists (GLP-1 RA) with a warning about pulmonary aspiration during general ...

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 ...