This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved
Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
No new studies have been requested
Companies to leverage proprietary IgM antibody technology platform to discover agonists against three oncology targets and three immunology/inflammation targets
50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
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