Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (EMA ...

On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for ...

EMA committee recommends marketing approval for Novartis’ Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer: Basel Saturday, October 19, 202 ...

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 Use ...

"If approved, Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who currently ...

If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible ...

Novartis announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion ...

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 ...

Recommendation is based on the Phase III NATALEE trial, where Kisqali added to endocrine therapy (ET) significantly reduced the risk of recurrence by 25% versus ET alone across a broad population of ...

The US FDA has approved Kisqali (ribociclib) for treating early-stage breast cancer in combination with hormone therapy. It targets high-risk HR-positive, HER2-negative stage II and III patients ...

The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat patients with earlier stages of the disease, drugmaker Novartis said Tuesday.