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January 04, 2023

US approval tracker: December 2022

December 22, 2022

Spotlight - Biotech tries everything it can in Nash

The Nash pipeline is pharmacologically diverse, and some projects look like very long shots.

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December 01, 2022

US FDA approval tracker: November 2022

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November 30, 2022

Go or no go? Mirati heads to the FDA

TG Therapeutics and Gilead also await a verdict, and Cytokinetics is set for a panel.

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November 10, 2022

U-turn confirms that the US cut-price oncology model is dead

EQRX tears up plans to challenge US PD-(L)1 players on price, and switches focus to two non-discounted small molecules.

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October 31, 2022

Go or no go? Apellis eyes an FDA outcome

Immunogen and Uniqure are also set for Pdufa conclusions.

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October 05, 2022

GSK moves ahead of Roche in the Tim3 race

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October 03, 2022

US FDA approval tracker: September 2022

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September 29, 2022

Go or no go? GSK takes its turn with a novel anaemia class

Amicus and Astrazeneca have notable approaching Pdufa decisions, while a panel for GSK’s daprodustat could change the course of a controversial drug class.

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September 01, 2022

US FDA approval tracker: August 2022

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August 31, 2022

Go or no go? Bristol’s Tyk2 test

A green light from the FDA is expected for deucravacitinib, while Amylyx, Ferring and Oncopeptides head for panels.

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