October 19, 2016 02:12 PM EDT

Now that Sarepta has bolted out of the barn, the FDA wants to shut the door

Now that the FDA has capped Sarepta’s long and controversial campaign to win an approval for its Duchenne muscular dystrophy drug with an accelerated approval …

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Now that Sarepta has bolted out of the barn, the FDA wants to shut the door

This article is available only to Premium subscribers

Sr. Manager/Associate Director, Document Control

Viridian Therapeutics

Waltham, MA, USA

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Now that Sarep­ta has bolt­ed out of the barn, the FDA wants to shut the door

This article is available only to Premium subscribers

Sr. Manager/Associate Director, Document Control

Viridian Therapeutics

Waltham, MA, USA

The elec­tion is Tues­day. What’s at stake for the phar­ma in­dus­try?

FDA cites Mark Cuban's drug com­pound­ing cen­ter in Dal­las with steril­i­ty, qual­i­ty con­cerns

'We play to win': As­traZeneca de­tails first re­sults for oral GLP-1 and broad­er obe­si­ty am­bi­tions

Rare dis­ease bio­phar­ma com­pa­nies weigh in on FDA's new in­no­va­tion hub

Is there room for MASH drugs in a GLP-1 world?

Gene ther­a­pies don’t have to cost $4 mil­lion: New pro­duc­tion plat­forms re­duce de­vel­op­ment costs and risks

Now that Sarepta has bolted out of the barn, the FDA wants to shut the door

The election is Tuesday. What’s at stake for the pharma industry?

FDA cites Mark Cuban's drug compounding center in Dallas with sterility, quality concerns

'We play to win': AstraZeneca details first results for oral GLP-1 and broader obesity ambitions

Rare disease biopharma companies weigh in on FDA's new innovation hub

Gene therapies don’t have to cost $4 million: New production platforms reduce development costs and risks