USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
The company received 1 (One) observation in the Form-483
The company received 1 (One) observation in the Form-483
Ranks among the top 15% companies globally
The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold
Globally, BRUKINSA is approved in more than 70 countries
46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options
AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with Spinal Muscular Atrophy (SMA)
The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval
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