Biosimilar, FDA and Insulin

FDA Okays New Rapid-Acting Biosimilar Insulin for Diabetes
The US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for treating adults and children with diabetes.
FDA approves Sanofi biosimilar product for treatment of diabetes
The U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric
FDA Approves Merilog, a Rapid-Acting Insulin Biosimilar Product
Insulin-aspart-szjj is the first rapid-acting insulin biosimilar approved and the third insulin product approved by the FDA.
FDA Approves Tocilizumab Biosimilar Avtozma
The Food and Drug Administration (FDA) has approved Avtozma ® (tocilizumab-anoh), a biosimilar to Actemra ® (tocilizumab), in both intravenous (IV) and subcutaneous (SC) formulations.
FDA approves subcutaneous Merilog for glycemic control in diabetes
The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes. Merilog (insulin-aspart-szjj, Sanofi-Aventis U.S.) was approved as biosimilar to Novolog (Novo Nordisk) for improving blood sugar control for individuals with the condition,
FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment
The U.S. Food and Drug Administration (USFDA) on Friday approved Merilog as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.
FDA Approves Sanofi’s Rapid Acting Insulin Biosimilar Merilog for Diabetes
The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control in adults and pediatric patients with diabetes mellitus. The regulatory action makes Merilog the first rapid-acting insulin biosimilar to gain FDA approval.
Sanofi gets FDA approval for NovoLog insulin biosimilar
Sanofi (NASDAQ:SNY) has received FDA approval for Merilog, a biosimilar of Novo Nordisk's (NVO) rapid-acting insulin product NovoLog, for the improvement of glycemic control in adults and children with diabetes mellitus.
Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
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Evolus announces FDA approval of Evolysse products
Evolus (EOLS) announced that the Food and Drug Administration has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid gels, the first two products in the Evolysse collection.
DOGE reportedly fired the FDA employees who were reviewing clinical trials for Elon Musk’s Neuralink
The Department of Government Efficiency fired the FDA employees who were responsible for overseeing the clinical trial ...
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Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...