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Approvable Letter

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May 13, 2022

UCB feels the pain of rejection

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May 03, 2022

China-backed US approvals continue to hang in the balance

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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 08, 2021

FDA seals Chemocentryx’s fate

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March 01, 2021

US FDA approval tracker February

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December 21, 2020

US regulator brings year-end joy for some

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October 13, 2020

Shedding light on Intercept’s opaque disclosure

Intercept’s woes have continued as a possible new liver toxicity signal was buried in a regulatory filing. What could this mean?

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September 17, 2020

Has 2020 been a big year for regulatory knockbacks?

An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.

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January 22, 2020

Internal FDA documents reveal a familiar story for Sarepta

The unexpected approval of Vyondys 53 followed an FDA power struggle, and turned on a vague commitment from Sarepta, it has emerged.

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January 18, 2019

US regulator wipes the smile off Immunomedics’ face

Issues with manufacturing, not exactly a new problem for Immunomedics, derail the company’s bid for glory.

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June 15, 2018

Snippet roundup: Panel says no to BTG and Sirtex says no to Varian

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