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US President Donald Trump with the signed Order

Trump signs order to hasten psychedelic medicine access

Donald Trump has signed an executive order directing the FDA to reduce regulatory hurdles that stand in the way of bringing psychedelics to patients.

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FDA accelerated approval path needs improvement, says ICER

The FDA's accelerated approval route has delivered important new drugs to patients quicker, but is opaque and plagued by inconsistencies, says ICER.

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FDA renews criticism of trial sponsors over transparency

The FDA has launched a drive to get clinical trial sponsors to disclose the results of studies – even if they are negative.

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Agios' chief medical officer, Sarah Gheuens

Agios mulls early FDA filing for sickle cell therapy

Agios is planning to file its sickle cell disease candidate mitapivat with the FDA under the accelerated pathway within the next few months.

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FDA points to liver injury with Amgen's Tavneos

The FDA has raised the pressure on Amgen to withdraw vasculitis drug Tavneos from the market with a report linking serious side effects to the drug.

Market Access

Is AI the missing link in fixing MLR – or the reason it brea...

Somewhere in a shared drive at a mid-size pharma company, there is a folder labelled “Q3 Messaging FINAL v3 (2).” Inside it are three Word documents with tracked changes from four people, n

Trump signs order to hasten psychedelic medicine access

FDA accelerated approval path needs improvement, says ICER

FDA renews criticism of trial sponsors over transparency

Agios mulls early FDA filing for sickle cell therapy

FDA points to liver injury with Amgen's Tavneos

Is AI the missing link in fixing MLR – or the reason it brea...

Infex chases after Insmed with bronchiectasis trial win

Discover a new era of healthcare panel engagement: Grounded ...

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