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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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image: FDA Study Halted After Jane Goodall Objects

FDA Study Halted After Jane Goodall Objects

By | September 26, 2017

The primatologist had written to the agency that the trial, which involved observing the effects of nicotine addiction in squirrel monkeys, was “cruel and unnecessary.”

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image: Majority of Top Government Science Jobs Unfilled

Majority of Top Government Science Jobs Unfilled

By | August 31, 2017

Only 12 positions out of 44 have received nominations, and half of Trump’s nominees have strong ties to the industries they would oversee, a new report shows.

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image: FDA Goes After Two Stem Cell Clinics

FDA Goes After Two Stem Cell Clinics

By | August 29, 2017

The agency raided one that was using a stem cell-smallpox vaccine combo, and sent a warning to another to obey best practices.

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image: FDA to Cut Back Hiring of Non-US Citizens

FDA to Cut Back Hiring of Non-US Citizens

By | August 14, 2017

The move appears to be out of step with other HHS agencies.

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image: Right-to-Try Bill Passes the Senate

Right-to-Try Bill Passes the Senate

By | August 4, 2017

The legislation removes restrictions for seriously ill patients to access experimental treatments that have not received FDA approval.

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image: Smallpox Kerfuffle Reveals Biosecurity Problems

Smallpox Kerfuffle Reveals Biosecurity Problems

By | July 12, 2017

A review of a 2014 incident in which mystery vials of smallpox were found at the NIH reveals security weaknesses, but also concludes the response was appropriate. 

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image: Opinion: Token Pharmacovigilance

Opinion: Token Pharmacovigilance

By | May 23, 2017

A US government website for collecting reports of side effects associated with vaccines is broken. Why has no one noticed?

4 Comments

Four products have already qualified for the regenerative medicine advanced therapy (RMAT) designation that provides extra interactions with the agency, and sooner.

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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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