Biosimilar Regulatory Updates - February 2024 | Goodwin
On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references...
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On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references...
According to a January 2024 press release from Accord BioPharma, Inc. ("Accord"), the FDA accepted Accord's abbreviated Biologics License Application (aBLA)...
CSL achieves a global milestone as Japan approves ARCT-154, the first sa-mRNA COVID-19 vaccine, showcasing CSL's commitment to innovation, efficacy, and prolonged protection against variants. Jonathan Edelman, MD, senior VP of CSL Vaccine’s Innovation Unit, speaks with ICT.
According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab),...
Dublin, Jan. 22, 2024 (GLOBE NEWSWIRE) -- The