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July 04, 2023

US FDA approval and panel tracker: June 2023

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June 30, 2023

Cymabay soars as Genfit hits an itch hitch

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June 23, 2023

Intercept: goodbye Nash, hello 2024 profitability

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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 22, 2023

Intercept’s Nash exit feels inevitable

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May 17, 2023

Viking’s Voyage is not over yet

A hit on one goal helps, but future Nash data will be more decisive.

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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 22, 2023

89Bio Enlivened by Nash success

The company follows Madrigal and Akero with a clinical hit.

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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 22, 2022

Spotlight - Biotech tries everything it can in Nash

The Nash pipeline is pharmacologically diverse, and some projects look like very long shots.

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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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