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Results For "Pharmaceuticals-and-Medical-Devices-Agency"

13 News Found

GlycoNex wins Japan nod to launch first human trial of lead program in gastrointestinal cancers
Clinical Trials | April 16, 2026

GlycoNex wins Japan nod to launch first human trial of lead program in gastrointestinal cancers

The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy


Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy
News | March 31, 2026

Novo Nordisk India sets patient-centred price of Rs. 202/day for starting dose of Ozempic and Wegovy

Price of the starting dose of Ozempic and Wegovy reduced by 36% and 48% respectively


Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy
News | July 03, 2025

Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy

ART-123 is a recombinant human thrombomodulin approved in Japan in 2008


Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved


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


Briefs: Granules India
Drug Approval | August 28, 2023

Briefs: Granules India

Granules India received approval from Brazilian Health Regulatory Agency ANVISA


Hutchmed completes rolling submission of NDA to USFDA for fruquintinib
Drug Approval | April 03, 2023

Hutchmed completes rolling submission of NDA to USFDA for fruquintinib

NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China


Japan homegrown COVID-19 mRNA vaccine needs superior safety and efficacy data for success, says GlobalData
News | October 01, 2022

Japan homegrown COVID-19 mRNA vaccine needs superior safety and efficacy data for success, says GlobalData

The booster vaccination trial is still ongoing and further data will provide more information around safety and efficacy.


Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients


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