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28/03/2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025 -
05/03/2025
List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) -
14/02/2025
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes -
31/12/2024
New Drug Therapy Approvals 2024 -
31/12/2023
FDA Novel Drug Therapy Approvals for 2023 -
30/12/2022
New Drug Therapy Approvals 2022 -
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 -
15/05/2020
EMA Biosimilars Medicines Overview -
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FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity -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