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FDA expecting boom in cell and gene therapies

Pledges clampdown on developers working outside regulations

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FDA moves into crisis mode as shutdown drags on

New drug appraisals already being affected

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US government shutdown leaves FDA running on empty

Funding row means shutdown could break 21 day record

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FDA takes aim at pharma’s biosimilar-delaying tactics

Ever-rising cost of insulins also to be targeted

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FDA clears Sandoz and Pear’s Opioid Use Disorder app

The app incorporates CBT to improve high relapse rates

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Pfizer claims rapid FDA nod for Lorbrena

Green light is latest in a string of cancer drug approvals

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AcelRX’s potent opioid tablets set to win FDA backing for pain relief

Panel voted 10 to 3 in favour of the treatment

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Insmed claims first FDA okay for limited population antibiotic

Arikayce is cleared to treat lung disease caused by MAC

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Alnylam seeks fast-track filing with biomarker data

Early filing reflects FDA desire for faster approvals

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Alexion adds to pipeline with $1.2bn Syntimmune buy

As company prepares for possible loss of patent protection for Soliris

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Teva wins FDA OK for crucial migraine drug

Vital to Teva's turnaround, Ajovy will challenge Novartis/Amgen's Aimovig

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FDA gives Loxo breakthrough tag for second cancer drug

US regulatory body to expect a NDA for LOXO-292 in late 2019

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