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Evaluate

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June 01, 2023

US FDA approval and panel tracker: May 2023

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May 31, 2023

Go or no go? Key FDA decisions for Argenx and Regeneron

Pdufa dates are also set for Sarepta and UCB, and panels will discuss Leqembi and Beyfortus.

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May 31, 2023

Sanofi tries a new mechanism in multiple sclerosis

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May 30, 2023

Further manufacturing woes could spell disaster for UCB

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May 25, 2023

Normal service resumes in amyotrophic lateral sclerosis

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May 05, 2023

What bear market? Acelyrin float is third-largest since 2018

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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 21, 2023

Finding the big spenders beyond big pharma

Developers like Vertex, Regeneron and Novo Nordisk have significantly upped R&D spending in recent years, and become important acquirers.

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April 21, 2023

Big pharma holds steady on research spending

R&D spending by the world’s largest drug makers flatlined in 2022, with Roche footing the biggest bill and Astrazeneca the fastest accelerator.

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April 03, 2023

Spotlight – following Humira in hidradenitis suppurativa

Immune agents old and new are trying to make a splash in what could turn into a billion-dollar market.

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March 31, 2023

Go or no go? Seagen's Padcev eyes FDA approval

Seres and Pfizer are also set for upcoming FDA Pdufa decisions, and a panel is scheduled for Astrazeneca and Merck’s Lynparza.

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A slow (and low) year for FDA approvals

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