Q3 2024 Earnings Call Transcript October 29, 2024 Novartis AG beats earnings expectations. Reported EPS is $2.06, expectations were $1.96. Operator: Good morning and good afternoon, and welcome to the ...
“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 ...
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 ...
We were the fastest growing CDK4/6 in Europe. Now, as I mentioned, the FDA approved Kisqali with a broad label fully in line with the NATALEE population, CHMP has issued a positive opinion ...
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 ...
Kisqali was approved as a treatment for early breast cancer by the U.S. Food and Drug Administration (FDA ... new indications or labeling for the investigational or approved products described in this ...
In September, Kisqali was approved by the FDA in this setting 5; at ESMO 2024, an updated analysis from NATALEE was presented, showing a deepening invasive disease-free survival benefit 6 “One-third ...
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 for adjuvant treatment ...