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Results For "Japan"

309 News Found

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


Asahi Kasei to build new filter assembly plant in Japan
News | February 17, 2022

Asahi Kasei to build new filter assembly plant in Japan

The construction is scheduled to begin in the third quarter of the calendar year 2022, with expected completion in early 2024


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


Bristol Myers Squibb receives approval for Abecma in Japan
Drug Approval | January 21, 2022

Bristol Myers Squibb receives approval for Abecma in Japan

It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan


Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan
Biotech | December 14, 2021

Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan

In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020


Sai Life Sciences receive Certificate of Inspection from Japan PMDA
Biotech | December 02, 2021

Sai Life Sciences receive Certificate of Inspection from Japan PMDA

The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product


Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan
Biotech | November 18, 2021

Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan

It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus