BRUSSELS, Feb. 24 (Xinhua) -- The European Medicines Agency (EMA) on Friday recommended approving a conditional marketing authorisation for Natpar, a medicine used to treat hypoparathyroidism, in the European Union (EU). Hypoparathyroidism is a hormone disorder where the parathyroid glands in th...
(translation of Rev Prescrire n掳 470 p. 884), we received a letterfrom a senior official at the European Medicines Agency (EMA):"The March 2023 issue of Prescrire International presents an opinion on the granting of a conditional marketing authorisation (CMA) for rucaparib (Rubraca) and ...
NEW BRUNSWICK, N.J., February 16, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisa...
Celltrion Group today announced that the Korean Ministry of Food and Drug Safety (MFDS) granted a Conditional Marketing Authorisation (CMA) for the emergency use of Regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment candidate INCHEON, Korea--(BUSIN...
Celltrion submitted today an application for Conditional Marketing Authorisation of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate to the Korean Ministry of Food and Drug Safety (MFDS) Celltrion plans to submit Emergency Use ...
According to the statistical analysis, ODs with a positive TPR conclusion (p-value<0.01), not subject to a conditional approval by the EMA (p-value<0.05) and approved without the obligation to conduct a post-authorisation safety study (PASS) (p-value<0.05), were statistically significant, ...