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Lyumjev first received FDA approval in June 2020 to reduce blood sugar levels and accelerate insulin uptake following meals in adults with type 1 and 2 diabetes. Read More
The approval was based on data “showing an overall response rate across three different types of VHL-associated tumors,” noted the open-label study’s principal investigator. Read More
Ipsen has withdrawn its new drug application (NDA) for palovarotene, an experimental treatment for an ultra-rare genetic disorder that causes tendons and ligaments to be replaced by bone. Read More
The FDA has rejected Sesen Bio’s biologics license application (BLA) for Vicineum (oportuzumab monatox-qqrs) for treating a form of bladder cancer. Read More
The news comes less than four weeks after the FDA’s Cardiovascular and Renal Drugs Advisory Committee said the drug should not be approved, citing concerns about the drug’s safety. Read More
Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates), already approved for narcolepsy, has won a new indication as a treatment for idiopathic hypersomnia (IH) in adults. Read More
In a study of 100 patients randomized to receive Nexviazyme or another FDA-approved enzyme replacement therapy, the two treatments showed similar efficacy in improving lung function. Read More