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BioWorld - Tuesday, May 12, 2026
Home » MHLW

Articles Tagged with ''MHLW''

Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 5, 2022
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021.
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Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 4, 2022
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021.
Read More
Abdominal pain illustration

Takeda’s Alofisel becomes Japan’s first approved allogeneic stem cell therapy with Crohn’s disease nod

Sep. 29, 2021
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
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Japanese flag

Eisai lands new MHLW approvals for lymphoma and carcinoma indications

March 30, 2021
By Gina Lee
HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate).
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Pills and bottle

After years of effort, Japan slashes drug lag

Dec. 8, 2020
By Alfred Romann
TOKYO – Steadily over a decade and a half, Japan’s drugs and devices regulator has all but eliminated a huge drug lag that put the second largest drug market in the world well behind most others in terms of the time it took for approvals and patient access to innovative drugs.
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Pills and bottle

After years of effort, Japan slashes drug lag

Dec. 7, 2020
By Alfred Romann
TOKYO – Steadily over a decade and a half, Japan’s drugs and devices regulator has all but eliminated a huge drug lag that put the second largest drug market in the world well behind most others in terms of the time it took for approvals and patient access to innovative drugs.
Read More
Japanese flag

Japan’s MLWH ends June with string of approvals, looks set for busy 2H 2020

July 7, 2020
By Gina Lee
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
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Japan’s MLWH ends June with string of approvals, looks set for busy 2H 2020

July 2, 2020
By Gina Lee
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
Read More
Japanese shield and coronavirus

Japan advances fight against COVID-19 with four-day approval for remdesivir

May 12, 2020
By David Ho and Gina Lee
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
Read More
Japanese shield and coronavirus

Japan advances fight against COVID-19 with four-day approval for remdesivir

May 8, 2020
By Alfred Romann and Gina Lee
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
Read More
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