Blog
RSS FeedPosted by Michael Wonder on 26 Jan 2017
U.S. FDA approves 72 mcg dose of Linzess (linaclotide) for adults with chronic idiopathic constipation
26 January 2017 - New dosage strength expected to be available in first quarter of 2017. ...
Posted by Michael Wonder on 26 Jan 2017
Narcan (naloxone hydrochloride) 2 mg nasal spray approved by FDA
25 January 2017 - Adapt Pharma to provide 2 mg as an additional dosing option for naloxone nasal spray ...
Posted by Michael Wonder on 25 Jan 2017
Health Canada approves Revlimid plus dexamethasone as a first-line treatment for patients newly diagnosed with multiple myeloma, not eligible for transplant
24 January 2017 - Celgene announced today that Health Canada has expanded the indication for Revlimid (lenalidomide capsules), in multiple myeloma. ...
Posted by Michael Wonder on 23 Jan 2017
Conditional marketing authorisations give patients access to important new medicines earlier
23 January 2017 - EMA publishes report with data collected between 2006 and June 2016. ...
Posted by Michael Wonder on 20 Jan 2017
Allergan announces FDA approval of Rhofade (oxymetazoline hydrochloride) 1% cream for the topical treatment of persistent facial erythema associated with rosacea in adults
19 January 2017 - Once daily treatment reduces persistent facial erythema associated with rosacea through 12 hours. ...
Posted by Michael Wonder on 20 Jan 2017
FDA approves Trulance for chronic idiopathic constipation
19 January 2017 - The U.S. FDA today approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation in adult ...
Posted 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 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
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 ...