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49 News Found

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


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


I Peace triples GMP cell manufacturing by expanding CDMO facility
Biotech | March 15, 2022

I Peace triples GMP cell manufacturing by expanding CDMO facility

The facility registration, along with DMF registration and GMP certification provides peace of mind to clients looking to use our iPSCs for clinical and commercial use in the United States, Japan, and other global markets


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


Johnson & Johnson Vision Care receives USFDA approval for drug-eluting contact lens
Drug Approval | March 06, 2022

Johnson & Johnson Vision Care receives USFDA approval for drug-eluting contact lens

Novel technology combines ACUVUE daily disposable contact lenses with an established antihistamine in FDA- first in its new category


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.


WHO establishes biomanufacturing training hub in South Korea
News | February 23, 2022

WHO establishes biomanufacturing training hub in South Korea

Bangladesh, Indonesia, Pakistan, Serbia and Vietnam to receive mRNA technology from the technology transfer hub


Daiichi Sankyo commences trial for booster mRNA vaccine against Covid-19
Biotech | January 31, 2022

Daiichi Sankyo commences trial for booster mRNA vaccine against Covid-19

DS-5670 is an mRNA vaccine against Covid-19 using a novel nucleic acid delivery technology discovered by the company


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


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward