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therapy designation
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BMS Received Breakthrough Therapy Designation for Its Investigational DCV Dual Regimen
Feb 26, 2014Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
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Vertex Pharmaceuticals Has Received Approval From The US Food and Drug Administration
Feb 25, 2014US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic ...
Tags: FDA Approval, Vertex, Kalydeco sNDA
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Palbociclib Received Breakthrough Therapy Designation by The United States Food
Feb 14, 2014Pfizer Inc. (NYSE:PFE) today announced that the randomized Phase 2 trial [PALOMA-1] of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival ...
Tags: Health&Medicine
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FDA Has Approved Sovaldi 400mg Tablets
Dec 10, 2013Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
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US-Based Pharmaceutical Firm Merck Has Received Breakthrough Therapy
Oct 24, 2013US-based pharmaceutical firm Merck has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational oral combination regimen MK-5172/MK-8742 for the treatment of chronic hepatitis C virus ...
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The FDA Has Approved Breakthrough Therapy Designation for Genmab and Arzerra
Sep 17, 2013The US Food and Drug Administration (FDA) has approved breakthrough therapy designation for Danish biotechnology company Genmab and British pharmaceutical company GlaxoSmithKline’s (GSK) Arzerra (ofatumumab) in combination with ...
Tags: therapy designation, Medicine
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NDA for The Investigational Oral BTK Inhibitor,Ibrutinib,Has Been Accepted by The US FDA
Sep 2, 2013Clinical-stage biopharmaceutical company Pharmacyclics' new drug application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, has been accepted by the US FDA for two B-cell malignancy indications. ...
Tags: Solvay Group, Medicine
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FDA Has Issued Breakthrough Therapy Designation
Aug 30, 2013The US Food and Drug Administration (FDA) has issued Breakthrough Therapy Designation for Catalyst Pharmaceutical Partners’ Firdapse (amifampridine phosphate), which is used to treat patients with Lambert-Eaton Myasthenic Syndrome ...
Tags: Therapy Designation, Medicine
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Janssen Research & Development Is Seeking FDA Approval for Use Ibrutinib in The Treatment
Jul 12, 2013Janssen Research & Development is seeking FDA approval for use of ibrutinib in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). The ...
Tags: FDA Approval, Janssen
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Pfizer Has Received Breakthrough Therapy Designation From The U.S FDA
Apr 15, 2013Pfizer has received breakthrough therapy designation from the United States Food and Drug Administration (FDA) for its investigational compound Palbociclib, a potential treatment for patients with breast cancer. The breakthrough therapy ...
Tags: Cancer Drug, Pfizer, Therapy Designation