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October 02, 2020
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
October 01, 2020
The approval of Nucala (mepolizumab) for treating hypereosinophilic syndrome represents the first drug approved for this group of rare blood disorders in nearly 14 years.
September 24, 2020
FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.
September 22, 2020
The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.
September 18, 2020
The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
September 15, 2020
GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.
September 09, 2020
Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.
September 08, 2020
As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.