Novartis has agreed to buy Regulus Therapeutics for up to $1.7 billion, giving the Swiss drugmaker access to an experimental drug to treat a life-threatening kidney disease.

EAST HANOVER, N.J., March 20, 2025 /PRNewswire/ -- Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of ...

Novartis has a third FDA-approved indication for its oral therapy for complement-mediated diseases – Fabhalta – after getting a green light in ultra-rare kidney disease C3 glomerulopathy (C3G).

The affirmative regulatory decision is the third for Novartis’s Fabhalta, building up the drug’s pipeline-in-a-product potential. But competition looms from a rival drug taking a similar approach.

Novartis’ kidney disease troika keeps marching forward. With a new FDA approval, the company’s Fabhalta has become the first treatment endorsed by the agency for the ultrarare kidney disease ...

The FDA has approved Novartis’ Fabhalta (iptacopan) as the first and only treatment for C3 glomerulopathy (C3G). Previously, patients with C3G were forced to rely on supportive care and broad ...

The FDA approved Novartis' Fabhalta, making it the first and only treatment for adults with C3 glomerulopathy. Fabhalta showed sustained proteinuria reduction in Phase 3 trials, with effects seen ...

Iptacopan's (Fabhalta; Novartis) approval makes it the first and only treatment approved for C3 glomerulopathy. The FDA approved oral iptacopan (Fabhalta; Novartis) to reduce proteinuria in adults ...

Basel, March 20, 2025 - Novartis today announced that oral Fabhalta ® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G) ...

Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a positive opinion for the label expansion of Fabhalta ...