Drug Approval | September 09, 2024
Granules India’s Gagillapur facility completes USFDA inspection with six observations
The recent inspection covered both cGMP and PAI processes
The recent inspection covered both cGMP and PAI processes
Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ?40%
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
This marks the first regulatory approval worldwide for nasally-delivered epinephrine
These results add to the growing body of evidence indicating a single dose of ABRYSVO provides strong immune protection against outcomes caused by RSV
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
Finerenone significantly reduced the composite of cardiovascular death and total (first and recurrent) heart failure events compared to placebo in addition to usual therapy
Decision on EU marketing authorisation for this population expected by September 2024
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