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“The approval of Dupixent for COPD is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks, while also facing the risk of hospitalization, irreversible health decline and feelings of hopelessness,” said George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at ...
September 27, 2024 at 9:39 AM. (Reuters) -The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly ...
The FDA later clarified that it has not approved any therapeutics or drugs to treat COVID-19, but that studies were underway to see if chloroquine could be effective in treatment of COVID-19. [ 146 ] [ 147 ] Following Trump's claim, panic buying of chloroquine was reported from many countries in Africa, Latin America and South Asia.
Dupilumab. Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody blocking interleukin 4 and interleukin 13, used for allergic diseases such as atopic dermatitis (eczema), asthma and nasal polyps which result in chronic sinusitis. [6][7][8][4] It is also used for the treatment of eosinophilic esophagitis [9] and prurigo nodularis.
AEs more commonly observed with Dupixent (≥5%) compared to placebo included injection site reactions (12% vs. 4%), accidental overdose (7% vs. 3%) and COVID-19 infection (8% vs. 5%). Detailed results from this trial will be provided to the U.S. Food and Drug Administration by year-end 2024 in response to the additional data requested for ...
In 2020, Sanofi, together with GSK, signed a deal with the US government's Operation Warp Speed to provide 100 million doses of COVID-19 vaccine for up to US$2.1 billion, if the vaccine was approved. [147] As of August 2020, COVID-19 vaccine development in Sanofi underscored its fundamental competitiveness weakness, with which management has ...
If approved, Dupixent would be the first and only medicine in the EU indicated for EoE in this age group Paris and Tarrytown, NY, September 20, 2024. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union ...
The EU Commission approved Dupixent to treat chronic obstructive pulmonary disease (COPD) in patients that cannot be helped by standard inhaled drugs, Sanofi said in a statement, following a ...