Drug Approval | June 13, 2025
FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C
Now approved for both acute and chronic HCV in adults and children aged 3 and above
Now approved for both acute and chronic HCV in adults and children aged 3 and above
The company received 1 (One) observation in the Form-483
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)
Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
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