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Filing & Registration

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March 17, 2023

Sarepta investors fear a panel beating

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March 14, 2023

Amylyx aces launch as tofersen’s big date approaches

Breakeven beckons for Amylyx.

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March 01, 2023

US FDA approval tracker: February 2023

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March 01, 2023

Reata gets a new lease of life

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February 28, 2023

Go or no go? Vaccines and neurology up for discussion

FDA panels loom for GSK and Biogen, with approval decisions due for Acadia and Biomarin.

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February 02, 2023

A small but notable win for GSK with daprodustat

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February 01, 2023

US approval tracker: January 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 19, 2023

Sun hopes to make Concert’s alopecia project shine

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January 18, 2023

A year of two halves for US approvals

FDA green lights picked up in the second half, but for the really impressive number look at year-five sales.

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January 13, 2023

Medtech approvals stagnate

Device approvals hit a nine-year low in 2022, as the FDA takes its foot further off the gas.

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Latest Reports

February 17, 2023

PD(L)anner – February 2023

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March 13, 2023

Silicon Valley Bank: biopharma’s latest crisis

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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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