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Rather, the breast cancer mutation screen was classified as a type of medical device with obligations for the company to reduce risks to customers.

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The agency gave personal genomics company 23andMe the green light to screen samples for breast cancer–related genetic mutations.

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image: First Blood Test for Concussion Approved by FDA

First Blood Test for Concussion Approved by FDA

By Kerry Grens | February 16, 2018

The diagnostic measures two proteins indicative of brain injury.

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image: EU Advisor Recommends Regulatory Exemption for Gene Editing

EU Advisor Recommends Regulatory Exemption for Gene Editing

By Catherine Offord | January 19, 2018

Crops produced using mutagenic technologies such as CRISPR should generally be exempt from regulatory laws governing GMOs, according to the published opinion.

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More than 200 people are on waiting lists for the $373,000 treatment as hospitals try to work around problems with insurers. 

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Spark Therapeutics’s Luxturna would be the first approved therapy in the U.S. that replaces or repairs a defective gene inherited from one’s parents.

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Tissue recipients were treated as “guinea pigs,” says investigation leader.

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image: Second-Ever ALS Drug Approved

Second-Ever ALS Drug Approved

By Jef Akst | May 8, 2017

Amyotrophic lateral sclerosis patients in the U.S. now have an option besides riluzole, which was approved by the FDA more than two decades ago and only extends life by two or three months.

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image: Drug Approval Timeline Same as 20 Years Ago

Drug Approval Timeline Same as 20 Years Ago

By Kerry Grens | January 9, 2017

A report finds that new medications still take about 12 years to go from patent to patient.

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image: Planning for the Next Ebola Outbreak

Planning for the Next Ebola Outbreak

By Bob Grant | January 20, 2016

A public-health nonprofit and an international drugmaker team up to stockpile hundreds of thousands of doses of a promising vaccine and to speed along the approval process.

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