This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
Japan’s Ministry of Health, Labour and Welfare (MHLW) has recently approved AstraZeneca's long-acting antibody combination “Evusheld” for the prevention ) and treatment of COVID-19.
COVID-19 Vaccine (DS-5670) in Unvaccinated Individuals in Japan
Approval for primary and booster immunization is based on efficacy and safety data from Japan and international clinical studies
Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients
This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan
Guardant360 CDx is a comprehensive genomic profiling test that utilizes blood samples from patients with advanced solid cancers
Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.
DS-5670 is an mRNA vaccine against Covid-19 using a novel nucleic acid delivery technology discovered by the company
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