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FDA authorizes 23andMe to market health-related genetic testing

2015-02-23 16:37:12| Extremetech

At long last, the FDA has authorized 23andMe to market health-related genetic testing. It's good news, but the impact of this is minimal for the time being. This specific authorization is for analysis of a single disease, but this "important first step" paves the way for the full suite of DNA analysis to return to the Mountain View-based genetics company.

Tags: market testing genetic fda

 

Block Scientific Offering FDA Cleared Beckman Access 25 (OH) Vitamin D Reagents at a Competitive Price

2015-02-23 11:30:53| Industrial Newsroom - All News for Today

An established lab equipment supplier based in New York, Block Scientific is offering the Access 25 (OH) Vitamin D Reagent (100 Determinations, 2 x 50 Tests) from Beckman Coulter at competitive pricing. Newly added to the store's portfolio, this FDA-approved assay is for use on the UniCel DxI series of immunoassay...

Tags: price access scientific block

 
 

Clariant Receives FDA Cosmetics Ingredients Certification

2015-02-20 08:27:00| Chemical Processing

Clariant is now ISO 22716 certified for all U.S. cosmetics ingredients sites through the Center for Food Safety and Applied Nutrition, FDA, U.S. Department of Health and Human Services.

Tags: certification receives ingredients cosmetics

 

Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC

2015-02-14 13:04:00| Biotech - Topix.net

Eisai Inc. announced today that the U.S. Food and Drug Administration approved the company's receptor tyrosine kinase inhibitor LENVIMA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer . LENVIMA was approved following a priority review by the FDA, which is designated for drugs the FDA believes have the potential to provide a significant improvement in the treatment of a serious condition.

Tags: treatment approval announces fda

 

BIO thanks retiring FDA Commissioner.

2015-02-11 14:30:51| Industrial Newsroom - All News for Today

BIO President and CEO Jim Greenwood issued statement regarding announced retirement of Dr. Margaret Hamburg. Dr. Hamburg presided over implementation of Food and Drug Administration Safety and Innovation Act and successful launch of breakthrough therapy designation program and other expansions of expedited approval pathways. These programs have proven invaluable in bringing groundbreaking new therapies to patients more efficiently, while maintaining FDA’s high standards for safety and efficacy.

Tags: bio commissioner fda retiring

 

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