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The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children. For this purpose, new data used for PUMA approved drugs are protected for 10 years, and the applications are partially exempt from fees. [1] In September 2011, the first drug was approved under this process.
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines or devices which have received marketing authorisation or are actively being studied in clinical trials in the European Economic Area (EEA).
As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]
The drug was approved for Friedreich's ataxia in Canada in 2008 under conditions including proof of efficacy in further clinical trials. [13] However, in February 2013, Health Canada announced that idebenone would be voluntarily recalled as of April 2013 by its Canadian manufacturer, Santhera Pharmaceuticals, due to the failure of the drug to ...
In March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of data on regdanvimab. [10] [11] In October 2021, the EMA started evaluating an application for marketing authorization for the monoclonal antibody regdanvimab (Regkirona) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who ...
On 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Lytgobi, intended for the second-line treatment of locally advanced or metastatic cholangiocarcinoma characterized by fusion or rearrangements of fibroblast ...
Tislelizumab, sold under the brand name Tevimbra among others, is an anti-cancer medication used for the treatment of various forms of cancer. It is a humanized monoclonal antibody directed against programmed death receptor-1. [4]
Enasidenib, sold under the brand name Idhifa, is an anti-cancer medication used to treat relapsed or refractory acute myeloid leukemia. [2] [3] It is an inhibitor of isocitrate dehydrogenase 2 (IDH2).