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Results For "Japan"

446 News Found

Takeda announces approval of Nuvaxovid Covid-19 vaccine in Japan
Drug Approval | April 19, 2022

Takeda announces approval of Nuvaxovid Covid-19 vaccine in Japan

Approval for primary and booster immunization is based on efficacy and safety data from Japan and international clinical studies


Sumitomo Chemical to build new API and intermediates plant in Japan
News | April 01, 2022

Sumitomo Chemical to build new API and intermediates plant in Japan

The plant is scheduled to come on stream in September 2024


Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors
Drug Approval | March 30, 2022

Ondexxya approved in Japan for reversal of acute major bleeds in patients on Factor Xa inhibitors

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


Dysval gets regulatory approval in Japan
Drug Approval | March 29, 2022

Dysval gets regulatory approval in Japan

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


Tarlige tablets approved in Japan for treatment of patients with neuropathic pain
Drug Approval | March 28, 2022

Tarlige tablets approved in Japan for treatment of patients with neuropathic pain

In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP


Japan approves BMS’ Breyanzi application for relapsed large B-cell lymphoma
Drug Approval | March 25, 2022

Japan approves BMS’ Breyanzi application for relapsed large B-cell lymphoma

This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan


Guardant Health receives regulatory approval for Guardant360 CDx in Japan
Medical Device | March 14, 2022

Guardant Health receives regulatory approval for Guardant360 CDx in Japan

Guardant360 CDx is a comprehensive genomic profiling test that utilizes blood samples from patients with advanced solid cancers


Japan tops CPhI ‘API Quality’ ranking for second year
News | March 13, 2022

Japan tops CPhI ‘API Quality’ ranking for second year

Digital meetings driving international partnering at CPhI Japan as companies search for ingredients suppliers


Japan approves Keytruda plus Lenvima for two types of cancer
Drug Approval | February 26, 2022

Japan approves Keytruda plus Lenvima for two types of cancer

Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.


Asahi Kasei to build new production unit for membrane virus filters in Japan
News | February 22, 2022

Asahi Kasei to build new production unit for membrane virus filters in Japan

The COVID-19 pandemic has triggered the rapid growth of the biotherapeutics market