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RSS FeedPosted by Michael Wonder on 18 Jan 2017
FDA grants fast track designation for aTyr's Resolaris to treat limb girdle muscular dystrophy 2B and removes partial clinical hold for Resolaris
18 January 2017 - First reported fast track designation for LGMD2B treatment. ...
Posted by Michael Wonder on 18 Jan 2017
Teva receives FDA approval for Vantrela ER (hydrocodone bitartrate) extended release tablets formulated with proprietary abuse deterrence technology
18 January 2017 - Vantrela ER label describes the product’s abuse-deterrent properties against abuse in the three most common routes—oral, ...
Posted by Michael Wonder on 18 Jan 2017
FDA approves a generic of Xyrem with a REMS Program
17 January 2017 - The U.S. FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat ...
Posted by Michael Wonder on 18 Jan 2017
Suliqua approved in the European Union for the treatment of adults with type 2 diabetes mellitus
17 January 2017 - Sanofi announced today that the European Commission has granted marketing authorisation in Europe for Suliqua, the once-daily ...
Posted by Michael Wonder on 18 Jan 2017
Will cardiovascular outcomes data on newer diabetes drugs bury the older agents?
17 January 2017 - Patients with type 2 diabetes are treated with many drugs other than insulin. In 2014, Medicare paid ...
Posted by Michael Wonder on 17 Jan 2017
Human medicines: highlights of 2016
17 January 2017 - 81 medicines recommended for approval, including 27 new active substances. ...
Posted by Michael Wonder on 16 Jan 2017
SMC - January 2017 decisions
16 January 2017 - The Scottish Medicines Consortium has today published advice accepting four new medicines for routine use in ...
Posted by Michael Wonder on 13 Jan 2017
Tesaro receives complete response letter for rolapitant IV from U.S. FDA
11 January 2017 - No concerns raised by FDA related to the rolapitant IV efficacy or safety profile and additional ...
Posted by Michael Wonder on 12 Jan 2017
Additional listings on the Pharmaceutical Schedule of a range of orthopaedic joint implants, additional CMF implants, associated products and bone cement with Stryker
12 January 2017 - PHARMAC is pleased to announce the approval of an amendment to the trauma, spine and CMF ...
Posted by Michael Wonder on 12 Jan 2017
Health Canada approves new heart failure treatment Lancora to reduce mortality and hospitalisations
10 January 2017 - Health Canada has issued a Notice of Compliance for Lancora (ivabradine hydrochloride), a new treatment shown to ...
Posted by Michael Wonder on 12 Jan 2017
European Commission grants marketing authorisation for Gilead’s Vemlidy (tenofovir alafenamide fumarate) for the treatment of chronic hepatitis B virus infection
11 January 2017 - Vemlidy is the first new treatment for chronic hepatitis B infection to be approved in the ...
Posted by Michael Wonder on 12 Jan 2017
NICE approves kidney cancer drug for NHS use
12 January 2017 - Patients with advanced kidney cancer will have routine NHS access to the drug everolimus following recommendations by ...
Posted by Michael Wonder on 11 Jan 2017
NICE publishes final guidance on the use of Keytruda for non-small-cell lung cancer
11 January 2017 - The guidance relates to the use of Keytruda (pembrolizumab) for treating PD-L1-positive non-small-cell lung cancer in adults ...
Posted by Michael Wonder on 10 Jan 2017
Fiasp (fast-acting insulin aspart) approved in Europe
10 January 2017 - Novo Nordisk today announced that the European Commission has granted marketing authorisation for Fiasp for the ...
Posted by Michael Wonder on 10 Jan 2017
Egalet receives FDA approval for Arymo ER (morphine sulphate) C-II, an extended release morphine product formulated with abuse deterrent properties for treatment of chronic pain
9 January 2017 - Egalet Corporation today announced that the U.S. FDA has approved Arymo ER (morphine sulphate) extended-release (ER) tablets ...