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.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has once again snubbed Translarna ...
The opinion rejects granting conditional marketing authorization to AB Science’s masitinib as an oral add-on treatment for ALS in the EU.
Novo Nordisk's Alhemo (concizumab) receives a positive opinion from the EMA's CHMP for hemophilia A or B with inhibitors. The ...
Europe’s drug regulator recommended two novel vaccines for influenza alongside updated composition for two COVID-19 vaccines ...
After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel ...
Alvotech develops and manufactures AVT03. STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA, have entered into agreements with Alvotech for the commercialization of AVT03, each partner with ...
Bayer on Tuesday said it had applied for marketing authorization with the European Medicines Agency (EMA) for its menopause ...
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 ...
Alnylam Pharmaceuticals (ALNY) announced the submission of a Type II Variation to the European Medicines Agency for vutrisiran, an ...
Christian Meyer and Gisela Grabow of Maiwald discuss potential changes to the EU pharmaceutical regulation and their ...
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