Pharmaceutical Technology on MSN2d
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.
Zacks Investment Research on MSN1d
FDA Grants Accelerated Approval to NVS Kidney Disease Drug
Novartis NVS obtains FDA approval of atrasentan, a potent and selective endothelin A (ETA) receptor antagonist, for the ...
MPR21h
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 ...
Medical Dialogues21h
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 ...
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 ...
Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year
The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval for Novartis AG’s (NYSE:NVS) Vanrafia ...
Managed Healthcare Executive1d
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 ...
MedPage Today10d
Skepticism Hangs Over Cancer Drugs Stuck With Accelerated Approval for Years
Opens in a new tab or window A report showed that in cancer drug indications that received FDA accelerated approval, demonstrated high clinical benefits correlated with shorter times to subsequent ...
Medscape9d
Faster Cancer Drug Approvals Tied to Clinical Benefits
Researchers analyzed pivotal and confirmatory trial characteristics, outcomes, and safety data for 102 cancer drug ...
BioSpace2d
Denali Goes All In on Neuroscience’s Thorniest Hurdle: Crossing the Blood-Brain Barrier
After some high-profile crashes, the one-time biotech darling is inching toward success with its Hunter syndrome treatment, ...
Fierce Pharma1d
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 ...
PMLive1d
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 ...