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Approvable Letter

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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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May 25, 2018

To avoid disappointment bet on cancer and musculoskeletals

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May 04, 2018

Snippet roundup: The good times roll for Moderna, but Mallinckrodt and Smith & Nephew flag

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April 24, 2018

Olumiant’s US path made no clearer by adcom vote

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March 09, 2018

Snippet roundup: A fillip for Pfizer but Merck KGaA comes under pressure

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February 28, 2018

Celgene’s ozanimod snafu adds insult to injury

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December 10, 2020

What the coming year might hold for biopharma

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December 11, 2020

Covid-19 vaccine developers remind the world that setbacks happen

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December 09, 2020

Astrazeneca’s vaccine looks increasingly like an also-ran

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November 09, 2020

Pfizer and Biontech snatch first Covid vaccine victory

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December 01, 2020

The promise and the perils of antigen testing

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