FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
For Immediate Release: February 14, 2025 EspañolToday, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes...Medical Gases — Current Good Manufacturing Practice
Submit Comments by 01/30/2026 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...Guidance for Industry
Submit Comments by 01/30/2026 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...Guidance for Industry
Docket Number: FDA-2025-D-4678 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry...Guidance for Industry
Docket Number: FDA-2025-D-4678 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry...All Drug Purchases Are
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