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Evaluate

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June 01, 2023

US FDA approval and panel tracker: May 2023

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April 27, 2023

Go or no go? Sarepta’s gene therapy faces scrutiny

SRP-9001 heads for its month of regulatory probing, as vaccines from GSK and Pfizer, and Genmab and Abbvie’s bispecific, await FDA approval decisions.

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April 11, 2023

Pfizer's fortunes overshadow first-quarter dealmaking

Aside from Seagen, small takeouts dominate the first quarter.

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March 01, 2023

US FDA approval tracker: February 2023

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January 30, 2023

Go or no go? Overcoming delays

US Pdufa decisions loom for Apellis and Travere, while Menarini and Lilly got their approval firsts already.

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January 10, 2023

Amgen saves biopharma’s buyout year

December’s $28bn takeout of Horizon bumps 2022’s M&A numbers to respectable levels.

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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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October 12, 2022

ESGCT 2022 – Sangamo strengthens its case in Fabry

The group looks like the gene therapy contender to beat, but that is not saying much.

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October 12, 2021

Idorsia’s Fabry flop puts focus on gene therapies

But questions about gene therapy safety could benefit the enzyme-replacement therapy incumbents.

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June 02, 2021

US FDA approval tracker: May 2021

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February 24, 2021

Hints of a quickening emerge in accelerated approval conversions

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Gene editing: overhyped or unstoppable tide?

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May 16, 2023

A slow (and low) year for FDA approvals

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