Drug approvals

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Novo Nordisk Seeks U.S. FDA Approval for Oral Type 2 Diabetes Medication

Novo Nordisk today announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for oral semaglutide, …

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Eli Lilly and Company Will Introduce Generic Insulin at Half Price of Humalog

Eli Lilly and Company today announced it will introduce a lower-priced version of Humalog®(insulin lispro injection 100 units/mL) in the U.S. The …

Diabasens® Approved in Canada to Relieve Cutaneous Pain Associated with Diabetic Neuropathy

Innovus Pharmaceuticals, Inc., an emerging commercial-stage pharmaceutical company announced that it received approval from Health Canada to market …

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FDA Approves Expanded Label for Sanofi’s Soliqua

The U.S. Food and Drug Administration (FDA) has approved the use of Sanofi’s Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 …

Novo Nordisk Seeks EMA and FDA Approval for Fiasp® to be Used for Kids

Novo Nordisk recently submitted label updates to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for …

FDA Approves Expanded Indication for dapagliflozin in Type 2 Diabetes, Kidney Disease

The U.S. Food and Drug Administration (FDA) has approved a label update for AstraZeneca’s FARXIGA® (dapagliflozin) and XIGDUO® XR …

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FDA Approves Use of 0.5 mL Dose of Influenza Vaccine in Children as Young as 6 Months of Age

The U.S. Food and Drug Administration has approved the use of the 0.5 mL dose of Fluzone® Quadrivalent (influenza vaccine) to include children …

FDA Advisory Committee Votes 50/50 on Approving New Type 1 Diabetes Drug

An advisory committee of the Food and Drug Administration (FDA) voted in a tie yesterday on the approval of a novel type 1 diabetes drug which would …