Drug Approval | May 29, 2024
Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL
Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation
Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation
If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
Impressive safety and efficacy for solid cancer patients followed by global clinical study plan
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
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
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