The CHMP recommends granting a marketing authorization to NVS' Fabhalta for the treatment of adults with C3 glomerulopathy, an ultra-rare, progressive kidney disease with no currently approved ...

Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year ...

If approved, Fabhalta® will be the only medicine indicated to selectively target the underlying cause of C3G1, an ultra-rare, progressive kidney disease with no currently approved treatments2-5 Phase ...

Basel: Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a ...

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 ...

EMA committee recommends marketing approval for Novartis oral Fabhalta to treat adults living with C3 glomerulopathy: Basel Monday, March 3, 2025, 10:00 Hrs [IST] Novartis announc ...

"If approved, Fabhalta will be the first C3G treatment available for patients living with this severe progressive disease.” said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism ...

Following the CHMP's recommendation to approve Fabhalta for the treatment of adults with C3G, the European Commission (EC) will make a final decision within two months. Discovered at Novartis ...

Health Canada has approved Novartis Canada’s Fabhalta (iptacopan capsules) as the first oral monotherapy to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) and haemolytic anaemia.

Canada NewsWire MONTREAL, Feb. 13, 2025 MONTREAL, Feb. 13, 2025 /CNW/ - Novartis Canada is pleased to announce that Health Canada has granted a Notice of Compliance for Fabhalta® ...