Drug Approval | August 16, 2025
Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations
The inspection concluded with NIL observations
The inspection concluded with NIL observations
The therapy delivers the full-length ABCA4 protein and has the potential to benefit all patients with ABCA4 mutations
Rivaroxaban is used to treat venous thromboembolism
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle
Prucalopride is prescribed for chronic idiopathic constipation
The submission is supported by positive results from the Phase 3 AMPLIFY trial
7-OH is a concentrated byproduct of the kratom plant and has shown potential for abuse by binding to opioid receptors
The submission is supported by results from the Phase 3b APEX study
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