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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Amgen's BiTE immunotherapy blinatumomab receives FDA priority review designation in acute lymphoblastic leukaemia
Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for the investigational ...
Posted by Michael Wonder on 05 Aug 2015
Teva and Eagle Pharmaceuticals announce NDA for bendamustine rapid infusion product accepted for filing
Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc. today announce that the New Drug Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Rapivab to treat flu infection
On December 19, the U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults. ...
Posted by Michael Wonder on 05 Aug 2015
FDA accepts BPL’s amended BLA submission for Coagadex (coagulation factor X, human)
Bio Products Laboratory, Ltd., a leading manufacturer of plasma-derived therapies, today announced that the U.S. Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 05 Aug 2015
Seres Therapeutics receives FDA breakthrough therapy designation for its lead product candidate, SER-109
Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, today announced that SER-109 (Firmacute Eubacterial Spores, Purified Suspension, Encapsulated), its ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new drug to treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder
On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Rexulti (brexpiprazole) as adjunctive treatment for adults with major depressive disorder and as a treatment for adults with schizophrenia
11 July 2015 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the US Food and ...
Posted by Michael Wonder on 05 Aug 2015
FDA Approves Relistor subcutaneous injection for the treatment of opioid-induced constipation in patients with chronic non-cancer pain
Salix Pharmaceuticals, Ltd. and Progenics Pharmaceuticals, Inc. today announced that the Food and Drug Administration has approved Relistor (methylnaltrexone bromide) 12 mg/0.6 mL subcutaneous ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants priority review for asfotase alfa as a treatment for patients with hypophosphatasia
Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company’s Biologics ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves J&J diabetes drug Invokamet
Regulators in the USA have given the green light to Johnson & Johnson's new diabetes combo Invokamet.
The US Food ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Sivextro to treat skin infections
The U.S. Food and Drug Administration today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin ...
Posted by Michael Wonder on 05 Aug 2015
Roche receives U.S. FDA breakthrough therapy designation for Actemra/RoActemra in systemic sclerosis, and will present new study results at EULAR 2015
Roche today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) status to Actemra/RoActemra (tocilizumab) ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA accepts Otsuka and Lundbeck's filing for review of brexpiprazole for the treatment of schizophrenia and as adjunctive therapy for the treatment of major depression
Otsuka Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Otsuka Holdings Co. Ltd., and H. Lundbeck A/S today announced that the ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces submission of palbociclib new drug application to the FDA
Pfizer Inc. today announced it has completed the submission of a New Drug Application (NDA) to the United States Food ...
Posted by Michael Wonder on 05 Aug 2015
Prezcobix (darunavir/cobicistat) approved in the U.S. for the treatment of adults living with HIV-1
Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved Prezcobix (darunavir ...