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June 01, 2023

US FDA approval and panel tracker: May 2023

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May 11, 2023

2023’s biggest launches: the story so far

Alzheimer’s has already grabbed attention but plenty of big regulatory decisions still loom for Sarepta, Crispr, Astellas and more.

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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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March 28, 2023

Profitability and pipeline in focus at post-pandemic Biontech

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March 16, 2023

Biologics look set to lose US drug price negotiation loophole

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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 14, 2022

Ash 2022 movers – Glycomimetics shakes off its sickle cell past

Meanwhile, there was bad blood between cell therapy players and their investors.

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December 11, 2022

Ash 2022 – toxicity still looms large for Regeneron’s bispecific

Another five treatment-related deaths, despite a dose regimen change, raise questions about whether odronextamab will be able to compete.

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December 09, 2022

Not so fast for some accelerated approvals

The US conditional approval pathway has enjoyed years of expansion, but now the FDA is trying to put the toothpaste back into the tube.

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November 04, 2022

Ash 2022 preview – Affimed and Aptose score

In oncology settings outside multiple myeloma investors have picked two early winners.

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June 03, 2022

Asco 2022 – Roche bids for the CD20 bispecific prize

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Latest Reports

July 27, 2023

H1 Round Up: The haves and the have-nots

July 21, 2023

ADA/EASL eBook

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Editor's Picks

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July 03, 2023

Astrazeneca and Daiichi’s big reveal disappoints

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July 13, 2023

Pharma finds a way to gain weight

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July 03, 2023

Protagonist investors flake as psoriasis pill disappoints

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June 29, 2023

Approaching datasets for big pharma

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June 27, 2023

Nkarta goes back to basics

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