The FDA has granted accelerated approval to Vanrafia to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.

Richard Lafayette, MD, FACP, Stanford University Medical Center, explains the significance of this second approval in a month for proteinuria reduction.

Novartis has claimed accelerated approval from the FDA for a second indication for Fabhalta – IgA nephropathy (IgAN) – as it charts a course to blockbuster sales for the drug. The US regulator ...

Since the Orphan Drug Act went into effect in 1983, more than 600 drugs have been approved for rare diseases, according to ...

AbbVie has picked up another indication for its JAK inhibitor Rinvoq in the EU, becoming the first approved oral therapy for giant cell arteritis. Novartis has claimed accelerated approval in the ...

The US FDA has granted accelerated approval to atrasentan (Vanrafia) for reducing proteinuria in adults with primary immunoglobulin A (IgA) nephropathy, according to an announcement by Novartis.

Ensuring timely completion of post-approval studies and enforcing appropriate regulatory actions based on negative trial results is necessary to minimize patient exposure to ineffective and ...

J.P. Morgan analyst Richard Vosser reiterated a Hold rating on Novartis AG (NOVN – Research Report) today and set a price target of CHF95.00.

Novartis (NVS) announced a planned $23B investment over five years in U.S.-based infrastructure, ensuring all key Novartis medicines for U.S.