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Diabetes, Type 1 News (Page 5)
Related terms: Insulin Dependent Diabetes, Juvenile onset diabetes, Type 1 Diabetes, Type One, Type 1, Type 1 Diabetes Mellitus
FDA Approves Lantidra (donislecel-jujn) Cellular Therapy to Treat Patients with Type 1 Diabetes
June 28, 2023 – Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the...
FDA Approves Tzield (teplizumab-mzwv) to Delay the Onset of Stage 3 Type 1 Diabetes
Tzield is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients, Tzield delayed the median onset of Stage 3 T1D by 25 months,...
Lyumjev (insulin lispro-aabc) Injection Approved by U.S. FDA for Children with Diabetes
October 14, 2022 – The U.S. Food and Drug Administration (FDA) approved an expansion of the indication for Eli Lilly and Company's rapid-acting mealtime insulin Lyumjev® (insulin lispro-aabc) ...
FDA Medwatch Alert: Mylan Pharmaceuticals Inc. Issues Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens U-100, Due to the Potential of Missing Labels on Some Pens
PITTSBURGH – July 5, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL pre...
FDA Medwatch Alert: Mylan Issues Voluntary Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label
April 12, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged i...
FDA Approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for Use in Insulin Pumps
INDIANAPOLIS, Aug. 16, 2021 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved an expanded label for Eli Lilly and Company's (NYSE: LLY) rapid-acting insulin, Lyumjev (insulin...
FDA Approves Semglee (insulin glargine-yfgn) as the First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
SILVER SPRING, Md., July 28, 2021 /PRNewswire/ – Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in a...
FDA Approves Lyumjev (insulin lispro-aabc injection) for Type 1 and Type 2 Diabetes
INDIANAPOLIS, June 15, 2020 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company's...
FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 11, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food an...
FDA Approves Fiasp (insulin aspart injection) for the Treatment of Children with Diabetes
PLAINSBORO, N.J., Jan. 6, 2020 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use as a new...
FDA Approves Fiasp (insulin aspart injection) for Use in Insulin Infusion Pumps for Adults with Type 1 or Type 2 Diabetes
PLAINSBORO, N.J., Oct. 22, 2019 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp (insulin aspart injection) 100 u/mL to...
FDA Approves Gvoke (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia
CHICAGO--(BUSINESS WIRE)--Sep. 10, 2019-- Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize...
FDA Approves Baqsimi (glucagon) Nasal Powder for the Treatment of Severe Hypoglycemia
July 24, 2019 – The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be...
Baxter Announces U.S FDA Approval of Myxredlin, the First and Only Ready-To-Use Insulin for IV Infusion
DEERFIELD, Ill. - July 22, 2019 Baxter International Inc. (NYSE:BAX), a global leader in sterile medication production and delivery, today announced the U.S. Food and Drug Administration (FDA)...
FDA Medwatch Alert: Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication
Audience: Patients and caregivers who use or are considering using pen injectors with pen needles to inject prescription medicines. Health care providers who treat patients, or who train...
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