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RSS FeedPosted by Michael Wonder on 27 Feb 2016
FDA approves new option for certain people with previously treated follicular lymphoma
26 February 2016 - the FDA has approved Gazyva (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyva alone as a ...
Posted by Michael Wonder on 26 Feb 2016
Lilly receives positive CHMP opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis
26 February 2016 - Ixekizumab is designed to specifically target IL-17A, a protein that plays a key role in driving underlying ...
Posted by Michael Wonder on 26 Feb 2016
Servier receives positive CHMP opinion for Lonsulf (trifluridine/tipiracil) for refractory metastatic colorectal cancer
26 February 2016 - Servier today announced that the CHMP of the EMA has adopted a positive opinion, recommending Lonsulf (trifluridine/tipiracil) ...
Posted by Michael Wonder on 26 Feb 2016
European CHMP adopts positive opinion for Gilead’s fixed-dose combination Descovy (emtricitabine/tenofovir alafenamide) for the treatment of HIV
26 February 2016 - Gilead Sciences, Inc. today announced that the CHMP, the scientific committee of the EMA, has adopted a ...
Posted by Michael Wonder on 26 Feb 2016
Sobi and Biogen receive positive opinion from CHMP for Alprolix (rFIXFc) for the treatment of haemophilia B
26 February 2016 - Alprolix would be among the first therapies in the EU to offer people living with hemophilia B ...
Posted by Michael Wonder on 26 Feb 2016
FDA approves new indication for Novartis drug Afinitor for progressive, non-functional gastro-intestinal and lung neuroendocrine tumors
26 February 2016 - Novartis today announced that the United States FDA approved Afinitor (everolimus) tablets for the treatment of adult ...
Posted by Michael Wonder on 26 Feb 2016
Feraccru receives marketing authorisation in Europe
26 February 2016 - Shield Therapeutics plc is pleased to announce that the European Commission has granted marketing authorisation across all ...
Posted by Michael Wonder on 26 Feb 2016
Allergan announces FDA approval of Aczone (dapsone) 7.5% topical gel for treatment of acne vulgaris
25 February 2016 - Allergan plc today announced that the Company has received approval from the U.S. FDA to market Aczone ...
Posted by Michael Wonder on 25 Feb 2016
Praxbind (idarucizumab) reimbursed in England, Ireland and Wales
17 February 2016 - Praxbind (idarucizumab) is now available to be used commercially in England, Ireland and Wales after the Health ...
Posted by Michael Wonder on 25 Feb 2016
Pfizer receives expanded FDA approval for Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
19 February 2016 - Ibrance is now approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced ...
Posted by Michael Wonder on 25 Feb 2016
Pfizer announces FDA approval of Xeljanz XR (tofacitinib citrate) extended-release tablets, the first and only once-daily oral JAK inhibitor treatment for rheumatoid arthritis
24 February 2016 - Pfizer Inc. announced today that the U.S. FDA has approved Xeljanz XR (tofacitinib citrate) extended-release 11 mg ...
Posted by Michael Wonder on 24 Feb 2016
EU green light for Lilly's lung cancer drug Portrazza
24 February 2016 - European regulators have approved Eli Lilly’s Portrazza as a treatment for patients with advanced non-small cell lung ...
Posted by Michael Wonder on 23 Feb 2016
PTC receives refuse to file letter from FDA for Translarna (ataluren)
23 February 2016 - The FDA states in the Refuse to File letter that the application was not sufficiently complete to ...
Posted by Michael Wonder on 19 Feb 2016
FDA approves Briviact to treat partial onset seizures
19 February 2016 - The U.S. FDA yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial ...
Posted by Michael Wonder on 15 Feb 2016
Alirocumab hypercholesterolemia or mixed dyslipidaemia: additional benefits not covered says IQWiG
15 February 2016 - An additional benefit compared to the appropriate comparator therapies has not been established for this substance because ...