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Results For "Japan"

309 News Found

Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD
News | March 29, 2025

Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD

Dupixent (dupilumab) approved as the first-ever biologic medicine in Japan for patients with Chronic Obstructive Pulmonary Disease (COPD)


Bayer files for approval of finerenone in heart failure in Japan
News | February 15, 2025

Bayer files for approval of finerenone in heart failure in Japan

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara
News | January 07, 2025

Japan Health Authority approves Biocon Biologics’ Ustekinumab BS, Biosimilar to J&J's Stelara

The biosimilar Ustekinumab has been developed and manufactured by the company


Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba Capsule 40 mg as additional formulation in Japan
Drug Approval | September 26, 2024

Asahi Kasei Pharma obtains approval to manufacture and sell Cresemba Capsule 40 mg as additional formulation in Japan

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg


Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan
News | August 30, 2024

Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan

Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025


Singhi Advisors facilitates acquisition of 85% stake of GMP Technical Solutions by Japanese Shinryo Corporation
News | July 22, 2024

Singhi Advisors facilitates acquisition of 85% stake of GMP Technical Solutions by Japanese Shinryo Corporation

This transaction is the third acquisition by three different Japanese players in this segment


7th India-Japan medical product regulatory symposium held at New Delhi
Policy | July 14, 2024

7th India-Japan medical product regulatory symposium held at New Delhi

Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations


Moderna and Mitsubishi Tanabe Pharma ink agreement to promote Moderna’s mRNA respiratory vaccine portfolio in Japan
News | July 14, 2024

Moderna and Mitsubishi Tanabe Pharma ink agreement to promote Moderna’s mRNA respiratory vaccine portfolio in Japan

The agreement has an initial term until March 31, 2029 and no further details on the financial terms of the deal are being disclosed


Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer
Drug Approval | June 26, 2024

Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care


Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer
Drug Approval | March 30, 2024

Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations