NORTH HOLLYWOOD, Calif. -- The International Myeloma Foundation IMF - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said the FDA decision granting "priority review" for VELCADE[R] in newly diagnosed myeloma recognizes the benefits of powerful new therapies and the need...
In this article Millennium Pharmaceuticals, Inc. reveals that the U.S. Food and Drug Administration FDA accepted for review and granted Priority Review designation of the Company's New Drug Application NDA for VELCADE for the treatment of relapsed and refractory multiple myeloma. Priority Review is granted by the FDA to an...
In this article Millennium Pharmaceuticals, Inc. informs that it has submitted a complete Marketing Authorization Application MAA to the European Agency for the Evaluation of Medicinal Products EMEA for the approval of bortezomib VELCADE as a treatment for relapsed and refractory multiple myeloma. This application was submitted approximately one week...
In this article Millennium Pharmaceuticals, Inc. informs that it has submitted a New Drug Application NDA with the U.S. Food and Drug Administration FDA for approval to market VELCADE as a treatment for relapsed and refractory multiple myeloma. In June 2002, VELCADE was granted fast-track status by the FDA as...
NORTH HOLLYWOOD, Calif. -- The International Myeloma Foundation IMF, the country's oldest and largest myeloma organization, applauds the U.S. Food and Drug Administration's FDA approval of VELCADER. This approval expands the label to include the treatment of multiple myeloma patients who have received at least one prior therapy. The approval...
MILLENNIUM Pharmaceuticals Inc. will trim its global work force by 26 percent and consolidate operations under a restructuring plan for profitability by 2006. The move comes on the heels of a critical Food and Drug Administration FDA approval for MILLENNIUM Pharmaceuticals Inc. will trim...
In this article Millennium Pharmaceuticals, Inc. informs that the U.S. Food and Drug Administration FDA accepted for review the Company's supplemental New Drug Application sNDA and granted Priority Review designation for VELCADE for the treatment of patients with multiple myeloma who have received at least one prior therapy. The submission...
In this article Millennium Pharmaceuticals, Inc. informs that the Food and Drug Administration FDA has granted VELCADE fast track designation for relapsed and refractory mantle cell lymphoma, an aggressive form of non-Hodgkin's lymphoma NHL which accounts for approximately six percent of all lymphomas. Currently, VELCADE is being evaluated as a...
This article discusses the Millennium Pharmaceuticals, Inc. approval from the U.S. Food and Drug Administration FDA to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on...
In this article Millennium Pharmaceuticals, Inc. informs that the Company intends to file a New Drug Application NDA with the U.S. Food and Drug Administration FDA to market VELCADE as a treatment for relapsed and refractory multiple myeloma by early 2003. Earlier this year, VELCADE was granted fast-track status by...
Japanese drug maker Takeda Pharmaceutical Co.'s Velcade has been given FDA approval for use on patients with previously untreated multiple myeloma. Velcade, previously approved for multiple myeloma patients who had tried another treatment unsuccessfully, was developed by Millennium Pharma, a biotechnology company recently acquired by Takeda...
New Indication Provides Treatment-Free Interval As an Option NORTH HOLLYWOOD, Calif. -- The International Myeloma Foundation IMF - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today applauded the decision by the US Food and Drug Administration...
- Five Oral Presentations at ASCO Annual Meeting Will Further Demonstrate the Strength of VELCADE Combinations in Front-line Multiple Myeloma - CAMBRIDGE, Mass., May 16 /PRNewswire/ -- Millennium Pharmaceuticals, The Takeda Oncology Company, today announced that new data from VELCADE clinical studies are scheduled to be featured...
NORTH HOLLYWOOD, Calif. -- The International Myeloma Foundation IMF - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said the FDA decision granting "priority review" for VELCADE[R] in newly diagnosed myeloma recognizes the benefits of powerful new therapies and the need...
JENKINTOWN, Pa. -- The National Comprehensive Cancer Network NCCN announces important updates to the NCCN Multiple Myeloma Guidelines. The NCCN Clinical Practice Guidelines in Oncology[TM] are widely recognized and applied as the standard of care in oncology in the United States in both the community and the...
The FDA granted approval to bortezomib (Velcade[R], Millennium Pharmaceuticals, Inc.), a proteasome inhibitor, for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions, and contraindications, is available at www.fda.gov/cder/foi/label/2006/021602s010lbl.pdf. [ILLUSTRATION...
New Hires Support STA-4783 Late Stage Development LEXINGTON, Mass. -- Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced two key hires to its management team. Dr. Anthony Williams has...
In Preclinical Studies, Novel HDAC Inhibitor Romidepsin Demonstrated Synergistic Activity When Combined with VELCADE([R] )Bortezomib in Multiple Myeloma Cells CAMBRIDGE, Mass. -- Gloucester Pharmaceuticals, Inc., an oncology focused specialty pharmaceutical company, announced today that the first patient has been treated in a phase I/II investigator-initiated...
Access Pharmaceuticals received approval from the FDA to market MuGard, an oral rinse product for the management of oral mucositis, a side effect afflicting over 40% of cancer patients undergoing radiation and chemotherapy. The FDA approved Millennium Pharmaceuticals' Velcade for the treatment of patients with mantle cell lymphoma MCL...
MELBOURNE, Australia & MENLO PARK, Calif. -- ChemGenex Pharmaceuticals (ASX: CXS, NASDAQ: CXSP) announced today that it has appointed Dr Ian Nisbet to the position of Vice-President of Oncology. Dr Nisbet will commence immediately with the company on a fractional basis and will assist with management of...
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