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71 News Found

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


Astellas receives FDA priority review for Zolbetuximab biologics license application
Drug Approval | July 10, 2023

Astellas receives FDA priority review for Zolbetuximab biologics license application

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients


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


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


FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric
Drug Approval | April 14, 2023

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression


No link between the use of ranitidine and cancer risk, claims Nature
News | February 24, 2023

No link between the use of ranitidine and cancer risk, claims Nature

N-nitroso dimethylamine (NDMA) is a probable human carcinogen and tts effects on humans rely on observational studies.


Moderna’s non-vaccine mRNA therapeutic set to generate $278 million in 2028 if approved, estimates GlobalData
News | February 17, 2023

Moderna’s non-vaccine mRNA therapeutic set to generate $278 million in 2028 if approved, estimates GlobalData

According to GlobalData’s analyst consensus forecast, OTX-2002 is projected to have the highest revenue by 2028, with sales of $1.6 billion during that year


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis
Clinical Trials | October 13, 2022

Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis

68% of children on a higher dose of Dupixent achieved histological disease remission at week 16


Merck and Eisai provide update on Phase 3 LEAP-002 trial evaluating KEYTRUDA
Clinical Trials | August 04, 2022

Merck and Eisai provide update on Phase 3 LEAP-002 trial evaluating KEYTRUDA

The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.