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9 June 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 July 2021
FDA Approves First Interchangeable Biosimilar Insulin for Diabetes Treatment -
14 April 2021
FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19 -
11 December 2020
Pfizer-BioNTech COVID-19 Vaccine -
10 March 2020
Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections -
30 January 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 June 2018
FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity -
4 June 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment -
15 May 2018
FDA approves first epoetin alfa biosimilar for the treatment of anemia -
28 September 2017
Amgen And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA™ Amgen to Begin Launching Biosimilar Adalimumab in Europe in 2018 -
22 June 2017
Pfizer Provides Update on Proposed Epoetin Alfa Biosimilar -
05 April 2016
FDA approves Inflectra, a biosimilar to Remicade