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A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
In July 2021, the U.S. Food and Drug Administration (FDA) granted priority review designation for the biologics license application (BLA) for the Pfizer–BioNTech COVID-19 vaccine with a goal date for the decision in January 2022. [277] [278] On 23 August 2021, the FDA approved the vaccine for use for those aged sixteen years and older. [33 ...
On 2 December 2020, the MHRA became the first global medicines regulator to approve an RNA vaccine when it gave conditional and temporary authorization to supply for use of the Pfizer–BioNTech COVID-19 vaccine codenamed BNT162b2 [22] [23] [24] (later branded as Comirnaty).
Pfizer (PFE)/BioNTech's (BNTX) mRNA-based COVID-19 vaccine, Comirnaty becomes the first vaccine to be granted full approval by the FDA.
Now that the Food and Drug Administration has fully approved a Covid-19 vaccine, the Pfizer-BioNTech shot dubbed Comirnaty, more employers and universities are mandating immunization. Some people ...
Singapore will soon be receiving a new batch of COVID-19 vaccines called Comirnaty, which is made the same way as the Pfizer-BioNtech vaccines.
The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, [37] is an mRNA vaccine [156] produced by the German company BioNTech and the American company Pfizer. [ 156 ] [ 157 ] [ 158 ] In Hong Kong, Macau, and Taiwan, Comirnaty is distributed by Fosun Pharma .
GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- LakeShore Biopharma Co., Ltd (Nasdaq: LSB) (“LakeShore Biopharma” or the “Company”), a global leader in the discovery, development, manufacturing, and delivery of next-generation vaccines and therapeutic biologics for infectious diseases and cancer, today announced the initiation of its Biologics License Application (BLA) submission ...