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Diabetes, Type 2 News (Page 22)
Related terms: Noninsulin-dependent Diabetes, Type 2 Diabetes, Diabetes, Type 2
Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
December 5, 2017 – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Ozempic (semaglutide) injection 0.5 mg or 1 mg, a...
FDA Medwatch Alert: Riomet (Metformin Hydrochloride Oral Solution): Recall - Microbial Contamination
ISSUE: Sun Pharmaceutical Industries is recalling two lots of Riomet (Metformin Hydrochloride Oral Solution), which were found to be contaminated with Scopulariopsis brevicaulis. Use of the affected...
FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes
23 October 2017 – AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon® BCise™ (exenatide extended-release) injectable suspension, a new formulation of By...
Novo Nordisk Receives FDA Approval for Fiasp (insulin aspart injection), a New Fast-Acting Mealtime Insulin
PLAINSBORO, N.J., Sept. 29, 2017 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp (insulin aspart injection) 100 Units/mL, a fast-acting...
Victoza (liraglutide) is Approved to Reduce the Risk of Three Major Adverse Cardiovascular Events in Type 2 Diabetes Patients
PLAINSBORO, N.J., Aug. 25, 2017 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular...
FDA Medwatch Alert: Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations
ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and...
FDA Approves Once-Daily Qtern (dapagliflozin and saxagliptin) Tablets for Adults with Type-2 Diabetes
28 February 2017 – AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2...
Novo Nordisk Receives FDA Approval of Tresiba (insulin degludec) for Use in Children and Adolescents With Diabetes
PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ – Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for...
FDA Medwatch Alert: Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer
ISSUE: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an...
FDA Approves Synjardy XR (empagliflozin/metformin hydrochloride extended-release) for Adults with Type 2 Diabetes
RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 12, 2016 /PRNewswire/ – The U.S. Food and Drug Administration (FDA) has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release)...
FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes
December 2, 2016 – The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2...
Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
PARIS, Nov. 21, 2016 /PRNewswire-USNewswire/ – Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection)...
Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes
PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ – Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for...
FDA Approves Invokamet XR (Canagliflozin/Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes
RARITAN, N.J., September 21, 2016 – Janssen Pharmaceuticals, Inc. (Janssen) announced today the U.S. Food and Drug Administration (FDA) has approved Invokamet XR - a once-daily, fixed-dose c...
FDA Medwatch Alert: GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe
ISSUE: Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile...
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