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Better coordination in development and review of vaccines is needed.
Advances in technology are accelerating the development and manufacture of subunit vaccines.
Contract manufacturers play a key role in the production of lipid nanoparticles for RNA vaccines.
May 10, 2023
EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.
May 01, 2023
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
January 30, 2023
FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.
January 02, 2023
Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.
December 20, 2022
FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.
October 21, 2022
The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.
The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.
October 13, 2022
FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.
September 27, 2022
Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.
September 02, 2022
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.