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Results For "Labour-and-Welfare"

21 News Found

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
News | June 27, 2023

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.


Astellas submits new drug application for Zolbetuximab in Japan
News | June 13, 2023

Astellas submits new drug application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers


Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer
Drug Approval | November 27, 2022

Japan approves ENHERTU for treatment of adult patients with HER2 positive unresectable breast cancer

Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial


GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA
Drug Approval | November 03, 2022

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan


AstraZeneca likely to see substantial Evusheld uptake in Japan, says GlobalData
Drug Approval | September 13, 2022

AstraZeneca likely to see substantial Evusheld uptake in Japan, says GlobalData

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.


Daiichi Sankyo announces initiation of Phase 3 Trial of mRNA
Diagnostic Center | September 01, 2022

Daiichi Sankyo announces initiation of Phase 3 Trial of mRNA

COVID-19 Vaccine (DS-5670) in Unvaccinated Individuals in Japan


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


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


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