Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable
The submission is supported by positive results from the Phase 3 AMPLIFY trial
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy
Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program
The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
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