Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
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
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