Kisqali, Novartis and European Medicines Agency
European Medicines Agency's Panel Supports Approval Of Novartis' Kisqali In Patients With Early-Breast Cancer
On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib). The CHMP recommended approval granting marketing authorization for Kisqali (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC),
Novartis' Kisqali Cancer Drug Gets Positive Opinion From European Medicines Agency
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 had adopted a positive opinion of Kisqali for the adjuvant treatment of adults with a type of early breast cancer, the most common cancer in Europe.
Leerink Partners analyst Joseph Schwartz has maintained their neutral stance on PTCT stock, giving a Hold rating on October 11. Joseph ...
After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel ...
The European Commission said Friday that it has officially adopted a new regulation explaining how it will cooperate more ...
Evergreen Theragnostics opens trial of 68Ga-EVG321 for patients with small cell lung cancer in European Union: Springfield, New Jersey Monday, October 21, 2024, 18:00 Hrs [IST] Ev ...
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that ...
Bayer is seeking EMA approval for darolutamide in metastatic hormone-sensitive prostate cancer, building on promising Phase III ARANOTE trial results. The treatment significantly lowers progression ...
Bayer seeks European approval for darolutamide in combo with ADT in patients with metastatic hormone-sensitive prostate cancer: Berlin Wednesday, October 16, 2024, 13:00 Hrs [IST] ...
announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).
Christian Meyer and Gisela Grabow of Maiwald discuss potential changes to the EU pharmaceutical regulation and their ...
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