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RSS FeedPosted by Michael Wonder on 05 Aug 2015
AbbVie Prices Hepatitis C Drug 12% Below Gilead Rival
AbbVie Inc. and Enanta Pharmaceuticals’s hepatitis C combination drug will be about 12 percent cheaper than its rival from Gilead Sciences Inc. ...
Posted by Michael Wonder on 05 Aug 2015
Novartis announces extension to FDA review period for multiple myeloma investigational compound LBH589
Novartis announced today that the US Food and Drug Administration (FDA) has extended their priority review period by up to ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves the first antihemophilic factor, Fc fusion protein for patients with Hemophilia A
The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (recombinant), Fc fusion protein, for use in adults and ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new treatment for chronic hepatitis C genotype 3 infections
The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) ...
Posted by Michael Wonder on 05 Aug 2015
Sprout Pharmaceuticals resubmits flibanserin new drug application for the treatment of hypoactive sexual desire disorder in pre-menopausal women
Sprout Pharmaceuticals announced today that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ...
Posted by Michael Wonder on 05 Aug 2015
UCB announces US and EU regulatory filings for the investigational antiepileptic drug brivaracetam
UCB today announced regulatory milestones in the US and the EU for its investigational antiepileptic drug brivaracetam. In the US, the ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces FDA acceptance of palbociclib new drug application with priority review
Pfizer Inc. today announced the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review ...
Posted by Michael Wonder on 05 Aug 2015
GSK receives FDA approval for Arnuity Ellipta (fluticasone furoate) in the US for the treatment of asthma
GlaxoSmithKline plc today announced that the FDA has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for maintenance treatment ...
Posted by Michael Wonder on 05 Aug 2015
Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero to help protect US adolescents and young adults
Novartis announced today the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves treatment for inhalation anthrax
The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer
The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent ...
Posted by Michael Wonder on 05 Aug 2015
Merck files for FDA approval of Keytruda in lung cancer
Merck & Co Inc said on Sunday it has submitted an application to the U.S. Food and Drug Administration for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema
The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Technivie for treatment of chronic hepatitis C genotype 4
The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Roche’s Lucentis (ranibizumab injection) for treatment of diabetic retinopathy in people with diabetic macular oedema
Roche announced today that the U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR), ...