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Tag: fda
FDA OKs first generic for Gleevec leukemia pill
2015-12-04 19:54:52| Chemicals - Topix.net
" U.S. regulators have approved the first generic version of one of the first very effective " and expensive " cancer drugs, Gleevec, which costs about $10,000 a month. The Food and Drug Administration granted a subsidiary of Indian drugmaker Sun Pharmaceutical Industries Ltd. approval to sell generic Gleevec, known as imatinib mesylate, in 100-milligram and 400-milligram pills for chronic myeloid leukemia.
Tags: generic
pill
fda
leukemia
Kind Asks FDA to Redefine 'Healthy'
2015-12-02 00:47:00| Food Processing
Says current definition focusing on low fats allows bad foods to use the term, precludes many good ones.
Intra-Operative 3D Surgical Navigation System has FDA clearance.
2015-12-01 14:31:04| Industrial Newsroom - All News for Today
Featuring FDA clearance, IQQA®-Guide supports intra-operative precision 3D navigation for surgical procedures of thoracic, abdominal, and pelvic soft-organs. Fully quantified and patient-specific IQQA® anatomic models, extracted from multi-modality images, are utilized for on-the-fly 3D navigation to support physicians in seeing through organ surfaces and quantitatively referencing anatomies of interest during surgery. Platform covers pre-operative planning, intra-operative navigation and monitoring, as well as post-operative assessment.
Tags: system
navigation
clearance
surgical
FDA Approves Blood Cancer Drug
2015-12-01 00:27:14| Biotech - Topix.net
The U.S. Food and Drug Administration said on Monday it had approved a drug to be sold by Bristol-Myers Squibb Co as a treatment for a form of blood cancer. The FDA said it approved the treatment, Empliciti, to be used in multiple myeloma patients in combination with Celgene Corp's Revlimid and common anti-inflammatory drug dexamethasone.
BioMarin's FDA Panel: Revisiting Biotech's Biggest Battle
2015-11-30 16:10:16| Biotech - Topix.net
BioMarin's exon-skipping drug, drisapersen, has occupied biotechnology investors' minds over the past week. is a debilitating muscular disease that affects boys less than 10 years of age and slowly causes progressive muscle wasting resulting in loss of walking ability, and respiratory and cardiac failure with 100% death rate within few years.
Tags: panel
battle
biggest
fda
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