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RSS FeedPosted 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 ...
Posted by Michael Wonder on 10 Jan 2017
Australian approval for drug that 'melts' leukaemia
10 January 2017 - A new anti-cancer drug with the power to ‘melt away’ certain advanced forms of chronic lymphocytic ...
Posted by Michael Wonder on 09 Jan 2017
Afstyla (rFVIII) for haemophilia A, receives European Commission approval
9 January 2017 - CSL today announced that the European Commission has granted marketing authorisation for CSL Behring’s Afstylta [recombinant ...
Posted by Michael Wonder on 09 Jan 2017
BioCryst receives Health Canada approval for Rapivab for the treatment of influenza
8 January 2017 - BioCryst Pharmaceuticals today announced that Health Canada has approved Rapivab (peramivir injection), an intravenous treatment for ...
Posted by Michael Wonder on 06 Jan 2017
FDA approves Genentech’s Lucentis (ranibizumab) for myopic choroidal neovascularisation
5 January 2017 - Granted priority review by the FDA. ...
Posted by Michael Wonder on 05 Jan 2017
New FDA drug approvals: breaking down the numbers
4 January 2017 - If a decline in FDA approvals of new pharmaceuticals is a bad sign for the industry, ...
Posted by Michael Wonder on 05 Jan 2017
Health Canada approves Orfadin capsules for treatment of hereditary tyrosinaemia type-1
4 January 2017 - Orfadin to be available in a range of dosing alternatives, including first ever 20 mg dosage. ...
Posted by Michael Wonder on 04 Jan 2017
A review of CDER’s novel drug approvals for 2016
4 January 2017 - This past year was another successful year for the new drugs program in FDA’s Center for Drug ...
Posted by Michael Wonder on 04 Jan 2017
U.S. FDA approves supplemental new drug applications to include landmark data in product labels for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets
4 January 2017 - The U.S. FDA approved supplemental new drug applications for three type 2 diabetes medicines within the empagliflozin ...
Posted by Michael Wonder on 03 Jan 2017
Two key FDA decisions to watch out for in January 2017
2 January 2017 - The drug development process is often lengthy and time-consuming and requires the utilisation of a lot ...
Posted by Michael Wonder on 02 Jan 2017
New drug approvals fall to six-year low in 2016
2 January 2017 - Last year turned out to be a disappointing one for new drug approvals with the U.S. ...
Posted by Michael Wonder on 31 Dec 2016
Costly drug for fatal muscular disease wins FDA approval
30 December 2016 - The FDA has approved the first drug to treat patients with spinal muscular atrophy, a savage ...
Posted by Michael Wonder on 30 Dec 2016
Cempra receives complete response letter from FDA for solithromycin NDAs
29 December 2016 - Cempra Pharmaceuticals today announced that the company has received a complete response letter from the U.S. ...
Posted by Michael Wonder on 28 Dec 2016
Shire announces FDA approval of Adynovate [anti-haemophilic factor (recombinant), PEGylated] for use in children and surgical settings
27 December 2016 - New FDA-approved indications for Adynovate provides more haemophilia A patients access to proven prophylaxis with a ...