FDA Approval Licensing Packaging Protein 
XTalks
AUGUST 2, 2023
Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. 2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. The FDA approved the drug over a decade ago in September 2009. billion in 2022.
The Pharma Data
DECEMBER 8, 2020
The company’s product candidates consist of novel human cells engineered to produce the crucial proteins, enzymes or factors needed by patients living with chronic diseases such as hemophilia, diabetes and lysosomal storage disorders. Pear’s reSET, reSET-O and Somryst are the first PDTs to receive FDA approval for treating disease.
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The Pharma Data
OCTOBER 30, 2020
The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
The Pharma Data
NOVEMBER 20, 2020
The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.
The Pharma Data
DECEMBER 5, 2020
BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. (NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. and the world, respectively, in 2020.
The Pharma Data
NOVEMBER 30, 2020
Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. The Company expects that the U.S.
The Pharma Data
DECEMBER 17, 2020
The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
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