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RSS FeedPosted by Michael Wonder on 29 Sep 2016
FDA eyes new diabetes outcome measures
29 September 2016 - A recent FDA workshop brought new diabetes outcome measures to the table, focusing on patient-oriented outcome measures. ...
Posted by Michael Wonder on 21 Sep 2016
U.S. FDA approves Invokamet XR (canagliflozin with metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes
21 September 2016 - Newest Invokana (canagliflozin) plus metformin treatment provides unique formulation option for first-line therapy. ...
Posted by Michael Wonder on 05 Sep 2016
Xultophy (insulin degludec/liraglutide) receives European approval for use in adults with type 2 diabetes mellitus and moderate renal impairment
1 September 2016 - Novo Nordisk has announced that the European Commission has approved the expanded use of Xultophy (insulin degludec ...
Posted by Michael Wonder on 22 Aug 2016
Sanofi provides update on new drug application for investigational once-daily fixed-ratio combination of insulin glargine and lixisenatide
19 August 2016 - Sanofi announced today that it has submitted updated information on the pen delivery device as part ...
Posted by Michael Wonder on 12 Aug 2016
Health Canada approves new indication for Jardiance (empagliflozin) tablets for adults with type 2 diabetes and established cardiovascular disease
11 August 2016 - Approval based on cardiovascular outcome clinical trial EMPA-REG OUTCOME, which demonstrated empagliflozin significantly reduced the incidence of ...
Posted by Michael Wonder on 28 Jul 2016
FDA approves Adlyxin to treat type 2 diabetes
28 July 2016 - The U.S. FDA approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along ...
Posted by Michael Wonder on 27 Jul 2016
EMA publishes EPAR for Qtern (saxagliptin hydrochloride with dapagliflozin propanediol monohydrate)
27 July 2016 - The EMA has published an EPAR for AstraZeneca's Qtern. ...
Posted by Michael Wonder on 21 Jul 2016
Health Canada approves Invokamet for the treatment of adults with type 2 diabetes mellitus
20 July 2016 - Janssen announced today that Invokamet, a twice daily fixed-dose therapy combining Invokana (canagliflozin) and metformin hydrochloride into ...
Posted by Michael Wonder on 20 Jul 2016
AstraZeneca receives approval in the EU for Qtern (saxagliptin and dapagliflozin) for treatment of type 2 diabetes mellitus
19 July 2016 - AstraZeneca today announced that the European Commission has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type ...
Posted by Michael Wonder on 19 Jul 2016
U.S. FDA expands indication for type 2 diabetes treatment Synjardy (empagliflozin/metformin hydrochloride) to include treatment-naïve adults
19 July 2016 - The U.S. FDA has approved an expanded indication for Synjardy (empagliflozin and metformin hydrochloride) tablets to include ...
Posted by Michael Wonder on 01 Jun 2016
U.S. FDA approves once-daily Jentadueto XR (linagliptin and metformin hydrochloride extended release tablets) for adults with type 2 diabetes
31 May 2016 - The US FDA has approved Jentadueto XR (linagliptin and metformin hydrochloride extended release tablets) for the treatment ...
Posted by Michael Wonder on 27 May 2016
Highlights from the CHMP 23-26 May 2016 meeting
27 May 2016 - Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval. ...
Posted by Michael Wonder on 17 May 2016
Prescription medicines: new or extended uses approved by the TGA
17 May 2016 - The TGA has published a list of the medicines it approved for new uses (new indications) ...
Posted by Michael Wonder on 27 Aug 2015
U.S. FDA approves Synjardy (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes mellitus
27 August 2015 - The U.S. Food and Drug Administration (FDA) has approved Synjardy (empagliflozin with metformin hydrochloride) tablets, from Boehringer ...