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.
As expected, Novartis’ radioligand therapy Pluvicto crossed the blockbuster sales threshold with one quarter still left of 2024. | Novartis didn't use a priority review voucher for Pluvicto's key ...
In addition to the recent FDA approval of Kisqali for EBC patients in the US and CHMP positive opinion in Europe, regulatory ...
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 ...
The European Commission is expected to make a decision on Kisqali's approval in this setting in the next two months.
If approved, Kisqali could nearly double the number of patients eligible for CDK4/6 inhibitor adjuvant therapy,” said Patrick Horber M.D., president, International, Novartis. “Together with the recent ...
Operator Good morning and good afternoon, and welcome to the Novartis Q3 2024 results release conference call and live ...
Abrysvo can prevent lower respiratory tract disease caused by RSV for people between the ages of 18 and 59 who are at ...
Jylamvo is an oral liquid formulation of methotrexate originally approved in 2022 for adults with acute lymphoblastic leukemia, among other diseases. The Food and Drug Administration (FDA) expanded ...
Scemblix (asciminib) received accelerated approval from the Food and Drug Administration (FDA) for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid ...
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA expanded the approval of the bivalent RSV prefusion F (RSVpreF) vaccine (Abrysvo) to include the prevention of ...
Six months after scoring FDA approval for hemophilia B gene therapy Beqvez, Pfizer has earned a nod from the U.S. regulator for another of its products in the indication. On Friday, the FDA signed ...