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25 January 2021
The Therapeutic Goods Administration (TGA) on Monday granted provisional approval to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for individuals aged 16 and older, making it the first COVID-19 vaccine authorized for use in Australia.

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25 January 2021
Effective use of real-world data and other data gathered outside the clinical trial arena requires a unified, big-picture approach, according to a new report from the first-ever big data stakeholder forum held by the European Medicines Agency (EMA...
25 January 2021
Looking back to 2020, the acting director of the US Food and Drug Administration’s Office of Prescription Drug Promotion (FDA’s OPDP) highlighted the office’s major initiatives and successes.
22 January 2021
Federal criminal charges have been filed against a man previously warned by the FDA for peddling unproven and unauthorized “vaccines” against COVID-19.
22 January 2021
Brexit readiness, regulatory science strategic planning, and medicine availability topped the list of big-picture areas of engagement between the European Medicines Agency (EMA) and industry stakeholders in a newly released biennial report.
22 January 2021
Updated 22 January  to include new information on brilacidin, convalescent plasma, bamlanivimab, Ilaris, Humira, and ivermectin. 
21 January 2021
Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.