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Evaluate

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May 16, 2023

A slow (and low) year for FDA approvals

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October 03, 2022

US FDA approval tracker: September 2022

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March 02, 2022

US FDA approval tracker: February 2022

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July 02, 2021

US FDA approval tracker: June

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May 27, 2021

Go or no go? Aducanumab’s day of reckoning

Next month the FDA will determine Biogen’s fate in Alzheimer’s, while Ascendis and Novo Nordisk also await Pdufa decisions.

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March 01, 2021

US FDA approval tracker February 2021

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January 27, 2021

Go or no go? Oncology decisions ahead for the FDA

The US regulator will provide verdicts on cancer projects from TG and Athenex, while Sarepta aims for its third Duchenne approval.

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October 02, 2020

US FDA approval tracker: September 2020

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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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August 28, 2020

Go or no go? A quiet month ahead for US approval verdicts

A decision is due on Bristol’s new leukaemia project, while Mallinckrodt and Mesoblast await their fates after mixed panel meetings.

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March 26, 2020

Biotech’s balancing act amid Covid-19 delays

A Vantage analysis suggests which small biotechs might seriously have to rethink R&D spending plans in the wake of Covid-19.

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May 16, 2023

A slow (and low) year for FDA approvals

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