Trials & Filings
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October 7, 2009
Baxter International, Inc. has been granted marketing authorization for Celvapan H1N1 pandemic vaccine from the European Commission.
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October 6, 2009
Bristol-Myers Squibb and AstraZeneca were granted marketing authorization for Onglyza from the European Commission.
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October 6, 2009
OncoGenex Pharmaceuticals, Inc. received an additional Fast Track Designation from the FDA for OGX-011 (custirsen sodium) for progressive metastatic prostate cancer in combination with first-line docetaxel treatment.
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October 5, 2009
GlaxoSmithKline and XenoPort, Inc. achieved positive results from a Phase II trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in patients with neuropathic pain associated with post-herpetic neuralgia (PHN), who have had an inadequate response to
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September 18, 2009
The FDA has approved Novartis’ Valturna (aliskiren and valsartan) tablets, a medicine targeting two key points within the renin system, also known as the renin angiotensin aldosterone system (RAAS), a regulator of blood pressure.
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September 17, 2009
GlaxoSmithKline and XenoPort, Inc. achieved positive results from a Phase IIb trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults.
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September 11, 2009
J&J unit Centocor Ortho Biotech Products received a Complete Response letter from the FDA regarding its sNDA for Doxil (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of metastatic breast cancer.
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September 11, 2009
Takeda Pharmaceutical Co. Ltd. and its wholly-owned subsidiary Millennium, The Takeda Oncology Co., initiated a Phase II trial of TAK-700 in patients with advanced prostate cancer.
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September 10, 2009
Merck has updated the status of the clinical development programs for MK-0974 (telcagepant) and MK-3207, the company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the treatment of acute migraine.
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September 4, 2009
Bristol-Myers Squibb’s BLA for belatacept has been accepted for filing and review by the FDA.
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September 4, 2009
Takeda Global Research & Development Center, Inc. received a complete response letter from the FDA regarding its NDA for the fixed-dose combination of alogliptin and Actos (pioglitazone HCl).
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September 1, 2009
Icagen, Inc. achieved positive results from a Phase IIa study of senicapoc in allergic asthma.
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August 28, 2009
Eurand N.V. received FDA approval for its NDA for Zenpep Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions.
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August 28, 2009
Takeda Pharmaceutical Co. Ltd. and Takeda Global Research & Development Center, Inc., received notification that the FDA has agreed to the study design for the cardiovascular (CV) outcomes trial EXAMINE for alogliptin, a selective DPP-IV inhibitor under i
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August 27, 2009
Genmab achieved positive results from a Phase II study of Arzerra (ofatumumab) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in front line follicular non-Hodgkin's lymphoma (NHL).
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