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October 08, 2020
Purdue University’s Continuity Pharma received a $1.5-million grant from DARPA to develop continuous manufacturing technology for generic drug products.
FDA approved the first commercial drug manufactured via Aji Bio-Pharma's proprietary production process.
October 07, 2020
A complete listing of event dates for CPhI and Pharmapack Europe 2021 has been released.
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
October 06, 2020
The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.
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 agency published recommendations for the development of drugs and biologics for the adjuvant treatment of renal cell carcinoma.
Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.
The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.