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  4. Fabre-Kramer Pharmaceuticals
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July 02, 2020

US FDA approval tracker: June

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May 28, 2020

Go or no go? A busy month ahead for US FDA decisions

June will be hectic for the US regulator, with many approval decisions due, including one for subcutaneous Arzerra in multiple sclerosis and Tazverik in follicular lymphoma.

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May 01, 2020

Go or no go? Oncology dominates upcoming decisions

Astrazeneca’s Lynparza is due US approval decisions in prostate and ovarian cancers, while Bristol's Opdivo’s fate will be determined in lung cancer.

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April 01, 2020

US FDA approval tracker: March

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March 23, 2020

Go or no go? Covid-19 upstages US regulatory decisions

A Vantage analysis of FDA decisions expected in the next month and how the ongoing Covid-19 pandemic could affect these.

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February 26, 2020

Go or no go? Ozanimod and Fintepla await FDA verdicts

Big approval decisions pending in March include ozanimod in multiple sclerosis, where Bristol-Myers is likely to win a green light, while the safety of Zogenix's…

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February 03, 2020

US FDA approval tracker: a first for Aimmune

January saw Aimmune receive an FDA approval for Palforzia, a first for peanut allergy, alongside decisions for Blueprint Medicines and Horizon Therapeutics.

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December 23, 2019

Go or no go? Enhertu’s destiny revealed and FDA decisions due for Epizyme, Novo

Enhertu gets an early thumbs up from the FDA – now decisions are due for Epizyme’s tazemetostat and Novo Nordisk's Rybelsus and Ozempic.

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February 07, 2012

Merck’s new sleep drug has soporific effect on markets

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US FDA approval tracker: April

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