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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 | 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 | 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 | 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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image: Drug Produced in GM Chicken Approved

Drug Produced in GM Chicken Approved

By | December 10, 2015

The US Food and Drug Administration greenlights a rare-disease drug that is produced in the eggs of genetically modified chickens.

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image: Clinical Trial Data Underreported: Study

Clinical Trial Data Underreported: Study

By | November 16, 2015

One-third of the human experiments for approved drugs failed transparency requirements.

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image: Doctor Who Blocked Thalidomide Dies

Doctor Who Blocked Thalidomide Dies

By | August 11, 2015

Frances Oldham Kelsey, a physician who halted use of a drug that caused birth defects in babies, has passed away at age 101.

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image: FDA OKs Herpes Blood Test

FDA OKs Herpes Blood Test

By | July 6, 2015

The US Food and Drug Administration approves Theranos’s fingerstick test for herpes.

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image: Device Trials Go Unpublished

Device Trials Go Unpublished

By | June 24, 2015

Just half of the clinical studies used to gain premarket approval for cardiac devices ever make it into the scientific literature.

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