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09/06/2022
FibroGen and Astellas receive NICE approval for Roxadustat as an option for treating symptomatic anaemia associated with chronic kidney disease (CKD) in adults -
28/07/2021
FDA Approves First Interchangeable Biosimilar Insulin for Diabetes Treatment -
14/04/2021
FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 -
30/01/2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on 2019 efforts to advance the development of complex generics to improve patient access to medicines -
21/06/2018
FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity -
15/05/2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment -
28/09/2017
FDA approves first epoetin alfa biosimilar for the treatment of anemia -
22/06/2017
Amgen And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA™ Amgen to Begin Launching Biosimilar Adalimumab in Europe in 2018