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January 19, 2021
Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.
The CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue.
January 15, 2021
This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.
January 14, 2021
A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies.
As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.
The Altrui Foundation is a non-profit organization that serves as a center point between manufacturers of unused medications and the charitable organizations that seek them.
January 11, 2021
WuXi STA served as the marketing authorization holder (MAH) and offered end-to-end support, including drug substance, amorphous solid dispersion, tablet, and packaging for the product.
The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.
The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.
January 07, 2021
The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.