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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

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FDA seeks input into 'opaque' priority voucher scheme

FDA seeks public input on controversial priority voucher scheme amid concerns about its transparency and legality.

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FDA approves higher Wegovy dose via 4th priority voucher

The US FDA has approved a fourth product via its new National Priority Voucher Programme - a 7.2 mg dose of Novo Nordisk's weight loss drug Wegovy.

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A white, pink-eyed mouse in surgical gloved hands

FDA publishes advice on animal testing alternatives

New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.

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...

FDA seeks input into 'opaque' priority voucher scheme

FDA approves higher Wegovy dose via 4th priority voucher

FDA publishes advice on animal testing alternatives

Senju launches first-in-class dry eye disease drug in Japan

Using AI-driven synthetic personas to take your insights fur...

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