PMLive2d
Novartis’ Vanrafia granted FDA approval for rare kidney disease IgA nephropathy
Novartis’ Vanrafia (atrasentan) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat ...
PharmExec2d
FDA Approves Novartis’ Vanrafia for Primary Immunoglobulin A Nephropathy
Approval was based on results from the Phase III ALIGN study, which demonstrated a significant reduction in proteinuria at 36 ...
MPR2d
Vanrafia Gets Accelerated Approval for Immunoglobulin A Nephropathy
The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ® (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid ...
Fierce Pharma3d
Vanrafia, 2nd drug in Novartis' IgAN troika, crosses FDA finish line in payday for Chinook investors
When Novartis bought kidney disease biotech Chinook Therapeutics in 2023 for $3.2 billion upfront, the deal included a ...
Pharmaceutical Technology on MSN3d
FDA grants accelerated approval to Novartis’ Vanrafia for IgAN
The approval is supported by a prespecified interim analysis from the ongoing, randomised Phase III ALIGN trial.
Managed Healthcare Executive3d
FDA Grants Accelerated Approval to Vanrafia for IgAN, a Rare Kidney Disease
Vanrafia reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). It has a wholesale acquisition cost ...
Medical Dialogues1d
FDA Grants Accelerated Approval to Atrasentan for IgA Nephropathy
The US FDA has granted accelerated approval to atrasentan (Vanrafia) for reducing proteinuria in adults with primary ...
pharmaphorum3d
Novartis gets FDA nod for second of three IgAN drugs
Vanrafia (atrasentan) is the first drug in the selective endothelin A receptor antagonist (ERA) class to be cleared in the US ...
Zacks Investment Research on MSN2d
Pharma Stock Roundup: FDA Nod to SNY, AZN & NVS, JNJ Talc Suits Failure
This week, the FDA approved Sanofi’s SNY hemophilia therapy, fitusiran, Novartis’ NVS Vanrafia for the reduction of ...
Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year
FDA grants accelerated approval to Novartis' Vanrafia for IgA nephropathy, with Phase 3 data in 2026 expected to support ...
Novartis gets FDA accelerated approval for Vanrafia
Novartis (NVS) “announced the FDA has granted accelerated approval for Vanrafia, or atrasentan, a potent and selective endothelin A receptor ...
KXAN4d
Novartis receives FDA accelerated approval for Vanrafia®
Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program 1 Phase III data showed ...