EMA accepts marketing authorization application for Ridaforolimus, investigational mTOR inhibitor - European Pharmaceutical ReviewHarvey J. Berger
1. 背景和概述 药品上市许可持有人(Marketing Authorization Holder,MAH)制度指拥有药品技术的药品研发机构、科研人员、药品生产企业、集团公司等主体,通过提出药品上市许可申请获得药品上市许可批件,并对药品质量在其整个生命周期内承担主要责任的制度。在该制度下,上市许可持有人和生产许可持有人可以是同一主体,也可以是...
Servier has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TIBSOVO (ivosidenib tablets) for two indications as a first line treatment, in combination with azacitidine, in patients with previously untreated IDH1-mutated acute myeloid ...
-owned subsidiary of Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee", stock code: 603087.SH) submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin glargine biosimilar to the European Medicines Agency (hereinafter referred to as "EMA")....
(EMA) has accepted the Company’s Marketing Authorization Application (MAA) for obecabtagene autoleucel (obe-cel). Obe-cel is Autolus’ lead investigational chimeric antigen receptor (CAR) T cell therapy, for the treatment of patients with relapsed/refractory (r/r) adult B-cell Acute ...
(JCN Newswire) - -Eisai Co., Ltd.announced today that theScientific Advisory Group(SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by theEuropean Medicines Agency(EMA). The me...
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 autho...
603087. SH) submitted the Marketing Authorization Application (hereinafter referred to as "MAA") of Insulin lispro biosimilar to the European Medicines Agency (hereinafter referred to as "EMA"), and recently received the Positive validation letter (formal acceptance notice)from the EMA, entering the...
(SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI®), which is currently under review by the European Medicines Agency (EMA). The meeting of the SAG is ex...
InflaRx N.V. (Nasdaq: IFRX) announced today that the Company has submitted a Marketing Authorization Application (MAA) for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress synd...