FDA delivers second complete response letter to Intarcia for ITCA-650 implant—a small, osmotic pump to treat type 2 diabetes.
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Novo Nordisk announced that the FDA has issued a Refusal to File letter covering the label expansion application for once-weekly Ozempic (semaglutide 2.0 mg) for the treatment of type 2 diabetes which was filed on 20 January 2021.
Biocon Biologics Ltd., a subsidiary of Biocon has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc. (NASDAQ: VTRS), has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
Lexicon Pharmaceuticals announced that it has received FDA regulatory feedback that the results of its SOLOIST and SCORED Phase III clinical studies of Zynquista (sotagliflozin) can support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.