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December 21, 2020
The guidance provides information on review timelines during the COVID-19 pandemic.
December 16, 2020
The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.
December 15, 2020
Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).
December 11, 2020
Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.
The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.
Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.
December 08, 2020
Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.
December 03, 2020
Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.
December 02, 2020
Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.
November 24, 2020
FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.