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Results For "Trastuzumab"

58 News Found

Biocon Biologics partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab
News | February 10, 2024

Biocon Biologics partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab

The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024


CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'
News | January 17, 2024

CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'

Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer


European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ
Drug Approval | August 30, 2023

European Commission approves Keytruda plus Trastuzumab and chemotherapy as first-line treatment for GEJ

KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population


Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ
News | June 17, 2023

Pembrolizumab + Trastuzumab and chemotherapy met primary endpoint as first line of treatment for GEJ

Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma


AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan
News | May 04, 2023

AstraZeneca Pharma India receives permission for sale and distribution of Trastuzumab deruxtecan

The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India


Trastuzumab deruxtecan type II variation application validated by EMA
Biotech | December 28, 2021

Trastuzumab deruxtecan type II variation application validated by EMA

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan
Biotech | December 14, 2021

Trastuzumab Deruxtecan supplemental New Drug Application for breast cancer submitted in Japan

In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020


Dr Reddy’s and Prestige BioPharma collaborate to commercialise trastuzumab biosimilar
Biotech | December 09, 2021

Dr Reddy’s and Prestige BioPharma collaborate to commercialise trastuzumab biosimilar

The license agreement grants Dr. Reddy's the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia