On Thursday, the FDA granted accelerated approval to Novartis AG’s (NYSE ... at risk of rapid disease progression. In ...
The US Food and Drug Administration has approved the use of Novartis' drug to reduce excess protein in the urine of patients with a type of kidney disease ... The FDA's latest approval was ...
Novartis NVS ... from the U.S. Food and Drug Administration for a treatment to bring down elevated levels of protein in the urine of adults who have a rare kidney disease. The approval follows ...
The US FDA has approved a new orphan drug to treat patients with Cushing’s disease who cannot be helped through surgery. Novartis’ Signifor (pasireotide diaspartate) injection has been ...
Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) for reducing proteinuria in adults with primary IgA nephropathy (IgAN), a rare, progressive ...
The FDA has approved Alnylam’s gene silencing drug ... As the kidney function worsens, oxalate can build up and damage other organs including the heart, bones and eyes. The disease is also ...
Incyte and Syndax will seek approval to launch two smaller vial sizes following the FDA's approval of Niktimvo (as a 50mg vial). Following FDA approval of the new vial sizes, the companies ...
The common, but serious, complication of chronic kidney disease is often seen in patients on hemodialysis. Upacicalcet is already approved for SHPT in Japan, where the drug “performed ...
Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its drug ...
Only those with early or mild disease will be eligible for the new drug, and an even smaller subset are likely to undergo the multi-step process needed to get a prescription. The FDA approved ...
