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95 News Found

Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules
Drug Approval | October 20, 2023

Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules

Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)


Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules
Drug Approval | October 05, 2023

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals


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


Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets
Drug Approval | June 14, 2023

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States


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


Zydus receives final approval from USFDA for Esomeprazole Magnesium
Drug Approval | June 09, 2023

Zydus receives final approval from USFDA for Esomeprazole Magnesium

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)


Top 20 global biopharma companies report 3.4% fall in market cap in Q1 2023: GlobalData
News | April 21, 2023

Top 20 global biopharma companies report 3.4% fall in market cap in Q1 2023: GlobalData

Bayer reported the highest market capitalization growth of 23.1% during Q1 2023


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