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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Aug 2015
Axsome Therapeutics announces FDA fast track designation for AXS-02 for the treatment of pain associated with complex regional pain syndrome
Axsome Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for AXS-02 for ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants Amgen priority review designation for ivabradine for the treatment of chronic heart failure
Amgen today announced the U.S. FDA has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer
The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell ...
Posted by Michael Wonder on 05 Aug 2015
Actavis receives FDA approval for Viibryd (vilazodone hydrochloride) 20 mg once daily as a therapeutic dose
Actavis plc. today announced the U.S. Food and Drug Administration (FDA) has approved a lower therapeutic dose of Viibryd (vilazodone hydrochloride) (20 mg) to ...
Posted by Michael Wonder on 05 Aug 2015
Enanta announces U.S. FDA grants priority review for AbbVie's investigational, all-oral, interferon-free treatment regimen for genotype 4 chronic hepatitis C infection
24 Apriul 2015 - Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb receives amended U.S. FDA breakthrough therapy designation for investigational daclatasvir-based hepatitis C regimen
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Jakafi to treat patients with a chronic type of bone marrow disease
The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer’s investigational vaccine candidate for Clostridium difficile receives U.S. Food and Drug Administration fast track designation
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s investigational Clostridium ...