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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 15, 2020
The approval comes after a Phase III trial that showed Keytruda reduced the risk of disease progression or death by 35%.
October 07, 2020
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
October 05, 2020
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.
October 02, 2020
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.
The agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.
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 EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
September 17, 2020
The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.