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August 01, 2022

US FDA approval tracker: July 2022

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June 01, 2022

US FDA approval tracker: May 2022

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May 04, 2022

US FDA approval tracker: April 2022

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April 01, 2022

Go or no go? Bristol's first-in-class hopes

April should mark the approval of some of the biggest drugs of 2022, including Alnylam's vutrisiran, while TG will hope to be spared pain at the PI3K adcom.

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November 01, 2021

US FDA approval tracker: October 2021

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October 22, 2021

Regulatory rejection flurry does not make a storm

Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.

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October 18, 2021

Avadel delay hands Jazz another narcolepsy boost

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October 01, 2021

Go or no go? UCB bids to make a mark in psoriasis

Chemocentryx and Avadel will also see important FDA regulatory action this month, while Omeros gets another delay.

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February 14, 2020

Upcoming events – Avadel takes on Jazz and Axovant awaits early results

Data will soon show whether Avadel’s FT218 is more convenient than Jazz’s Xyrem, while Axovant will be looking for a dose response with its Parkinson’s gene therapy.

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January 02, 2020

US FDA approval tracker: December 2019

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December 02, 2019

Go or no go? Vascepa’s finale and Allergan's pain relief

Amarin’s Vascepa and Allergan’s migraine project ubrogepant are the high-profile pending FDA approval decisions as the sector heads into the last month of the year.

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