Novartis Wins FDA Approval of Kisqali
Novartis’ Kisqali receives FDA approval to reduce the risk of breast cancer recurrence
Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive,
Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer
An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.
Novartis Wins FDA Approval of Kisqali for Early Breast Cancer
Novartis NVS announced that the FDA has approved breast cancer drug Kisqali (ribociclib) for a broader population. The regulatory body approved Kisqali in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence,
FDA awards Novartis expanded approval for breast cancer therapy
The potential market for the Novartis drug Kisqali could grow markedly, now that certain early-stage breast cancer patients will be able to receive it.
FDA expands approval of breast cancer drug Kisqali to earlier-stage 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.
Novartis’ Kisqali gets expanded FDA OK; Mene Pangalos joins Omega Funds
The FDA’s clearance could double Kisqali’s breast cancer market. Elsewhere, Novo is exploring new ways to deliver genetic therapies and Bain is funding a growing CDMO.
Novartis AG: Hold Rating Justified Amid Kisqali’s Market Potential and FDA Approval
Analyst Eric Le Berrigaud from Stifel Nicolaus maintained a Hold rating on Novartis AG (NOVN – Research Report) and keeping the price
Novartis’ Kisqali cleared for expanded indication by FDA
The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence,
Novartis’ Kisqali receives US FDA approval to reduce risk of recurrence in people with HR+/HER2- early breast cancer
Novartis’ Kisqali receives US FDA approval to reduce risk of recurrence in people with HR+/HER2- early breast cancer: Basel Thursday, September 19, 2024, 13:00 Hrs [IST] Novarti
FDA Expands Use of Breast Cancer Drug Kisqali
The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn't spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr.
Novartis CEO says FDA's extended approval of breast cancer drug is a 'landmark' for the firm
Vas Narasimhan, CEO of Novartis, comments on the progress of the firm's Kisqali metastatic breast cancer drug after the company recently received an extended approval for it from the U.S. Food and Drug Administration.
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FDA expands Novartis’ Kisqali label to include early breast cancer patients
The US Food and Drug Administration (FDA) has approved a label expansion for Novartis’s Kisqali (ribociclib), allowing it to be used as an add-on therapy in early breast cancer patients. The ...
The Pharma Letter3d
ESMO 2024: Novartis’ Kisqali shows deepening benefit beyond three-year treatment period
Novartis presented updated Phase III NATALEE trial results at ESMO 2024, showing that Kisqali (ribociclib) with endocrine ...
Business Insider2d
Maintaining Hold on Novartis: Kisqali’s Approval Meets Expectations Amid Patent Risks
Graham Parry has given his Hold rating due to a combination of factors surrounding Novartis AG’s recent approval of Kisqali. The drug’s approval for use in early breast cancer with a broad label ...
pharmaphorum2d
Lilly on alert as new Kisqali approval threatens Verzenio
Verzenio was approved for a similar adjuvant indication last year, having been used for a couple of years only in patients ...
Novartis' Multiple Sclerosis Drug Data Shows Most Patients Remain With No Disability Progression For Up To Six Years
Novartis AG (NYSE:NVS) released new data Wednesday from the ALITHIOS open-label extension study. Data show first-line ...