The FDA's evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
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The vaccine had been authorized for use in adults 18 years of age and older.
For the Pfizer-BioNTech vaccine, the FDA amended the EUA to include use of…
-- The EUA Submission Follows Positive Phase 3 COVID-19 Clinical Trial in which Sabizabulin Demonstrated a 55.2% Reduction in Death in Hospitalized COVID-19 Patients -- -- The Company is…
BE submitted the interim safety data and immunogenicity data to regulatory agencies. For both the age subsets, the trial showed a significant increase in the anti-RBD IgG antibodies and…
India’s drug regulator has granted emergency use authorisation for Biological E’s COVID-19 vaccine Corbevax for those aged five to 12 years and Bharat Biotech’s Covaxin for children in the…
WALTHAM, Mass., April 14, 2022 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc. (Nasdaq: ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and…
The Novavax vaccine is manufactured and marketed in India by SII under the brand name, Covovax. The Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for…