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September 01, 2022

US FDA approval tracker: August 2022

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January 05, 2022

US FDA approval tracker: December 2021

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November 30, 2021

Go or no go? Argenx's December showdown

2021 rounds off with key FDA decisions for Argenx, Calliditas and Merck, while Novartis will be hoping for an early Leqvio verdict.

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April 01, 2021

US FDA approval tracker: March 2021

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March 01, 2021

Go or no go? A delayed decision on Evrenzo

March will see big US decisions for Evrenzo and ide-cel, while tanezumab goes in front of an advisory committee.

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January 19, 2021

Biohaven pops the Alzheimer’s bubble

Troriluzole has failed in an Alzheimer’s trial, reminding the markets that this is par for the course in this disease.

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October 02, 2020

US FDA approval tracker: September 2020

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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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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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January 24, 2020

Upcoming events – Genmab's route to market, and late-stage data for Zogenix

Genmab is seeking data to position tisotumab as its first in-house launch, while Zogenix wants Fintepla to challenge GW in Lennox-Gastaut syndrome.

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December 02, 2019

US FDA approval tracker: November 2019

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