Vifor Pharma and partner Travere Therapeutics on Friday won an endorsement for approval from the European Union's drug regulator for their drug Filspari, part of an industry.
The U.S. Food and Drug Administration (FDA) granted full approval to Swedish drugmaker Calliditas Therapeutics' drug to treat rare kidney disease IgA Nephropathy (IgAN), the.
The US FDA gave accelerated approval to sparsentan as the first non-immunosuppressive therapy labeled for IgA nephropathy. Conventional approval awaits clinical outcomes data.
Delayed-release budesonide reduced proteinuria in patients with primary IgA nephropathy in a pivotal trial, which led to an FDA accelerated approval in December 2021 for the orphan drug.
Oral budesonide delayed-release (Tarpeyo) became the first agent to receive FDA approval for reducing proteinuria in patients with primary IgA nephropathy and at risk for rapid progression.