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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: 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 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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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: Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy

Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy

By | February 1, 2017

What can be done to lower development costs and drug prices?

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image: New FDA Center Aims to Expedite Cancer Treatment Reviews

New FDA Center Aims to Expedite Cancer Treatment Reviews

By | June 30, 2016

The Oncology Center of Excellence, a product of the White House’s Cancer Moonshot initiative, will bring together oncologists across the US Food and Drug Administration.

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image: FDA Head Confirmed

FDA Head Confirmed

By | February 24, 2016

The US Senate approves the Obama administration’s nominee, Robert Califf, as the next commissioner of the Food and Drug Administration.

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image: FDA to Test for Glyphosate in Food

FDA to Test for Glyphosate in Food

By | February 22, 2016

The US Food and Drug Administration will begin testing certain foods for residues of the active ingredient in the herbicide Roundup.

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image: Pharma Firms Comply with New Antibiotics Rules

Pharma Firms Comply with New Antibiotics Rules

By | March 31, 2014

Most drug manufacturers agree to follow the Food and Drug Administration’s new labeling guidelines for antibiotics used in farm animals.

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image: FDA Considers Easing Controls on Diabetes Drug

FDA Considers Easing Controls on Diabetes Drug

By | June 11, 2013

A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.  

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