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image: FDA Approves Second CAR T-Cell Therapy

FDA Approves Second CAR T-Cell Therapy

By | October 19, 2017

The therapy, produced by Kite Pharma and owned by Gilead Sciences, is approved for use against some types of large B-cell lymphomas. 

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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?

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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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