In the European Union (EU), Orphan Drug designation is given to drugs or biologics intending to improve the treatment, diagnosis, or prevention of rare or serious illnesses. To be…
The FDA has just announced its accelerated approval of the very first therapy which can reduce proteinuria (high levels of protein in the urine) in patients diagnosed with primary immunoglobulin…
The FDA has recently granted Accelerated Approval to Tarpeyo, also called budesonide, to reduce proteinuria in patients with IgA nephropathy (IgAN). Tarpeyo is the first and currently the only treatment…
According to DocWireNews, on December 16, 2021, the U.S. Food and Drug Administration (FDA) granted Accelerated Approval to Tarpeyo (budesonide) delayed-release capsules. The therapy is designed to treat adult…
From June 5-8, 2021, the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) held its 58th Annual Congress. Though the event was held virtually, the meeting still expanded…
As reported in PR NewsWire; this March, Calliditas Therapeutics AB announced they have submitted a New Drug Application (NDA) for their novel oral solution, Nefecon, to treat primary IgA Nephropathy…
Since its conception, biotechnology company Chinook Therapeutics, Inc. ("Chinook") has worked to develop therapeutic solutions for patients with kidney diseases. Now, the company enrolled the first patient in a…
Immunoglobulin A nephropathy (IgAN) is a glomerular disease which can lead to kidney failure. Between 70 and 100 percent of all IgAN patients also are diagnosed with microscopic hematuria, but…
According to a story from pharmalive.com, the drug company Calliditas Therapeutics will plan to seek approval for its therapy Nefecon from the US Food and Drug Administration (FDA). This approval…
Recently, biopharmaceutical company Everest Medicines ("Everest") announced positive topline data from the Phase 3 NefIgArd trial, which was run by its licensing partner Calliditas Therapeutics AB ("Calliditas"). Together, the…
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