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January 04, 2023

US approval tracker: December 2022

December 30, 2022

Regulatory developments over the Christmas period

The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.

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December 22, 2022

Go or no go? Lecanemab’s destiny approaches

2023 begins with FDA decisions for Eisai’s Alzheimer’s project and Pfizer’s zavegepant, with an adcom for Cidara’s rezafungin.

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July 04, 2022

US FDA approval tracker: June 2022

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May 31, 2022

Go or no go? The FDA’s Amylyx dilemma

June will see adcoms aplenty, with Bluebird, Acadia, and the Covid vaccine makers Novavax, Pfizer/Biontech and Moderna all facing FDA committees.

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July 03, 2019

Share price catalysts: June 2019

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May 30, 2019

Go or no go? Merck, Regeneron and Alexion await US expansion

Approvals for new uses of old drugs should far outweigh nods for novel projects in June.

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Latest Reports

February 17, 2023

PD(L)anner – February 2023

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Biopharma and Medtech Review 2022

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March 13, 2023

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March 13, 2023

Pfizer rescues biotech

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February 28, 2023

Why Pfizer (and others) will be interested in Seagen

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March 04, 2023

ACC 2023 – Esperion’s outcomes win looks lacklustre

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March 06, 2023

T-cell receptor behemoths consolidate? Not quite

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