regulatory

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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.

R&D

Test tubes being prepared for flow cytometry

Overcoming 6 data management challenges in flow cytometry

Large-scale flow cytometry delivers critical biological insight by enabling multidimensional analysis of individual cells, making it fundamental to medical research.

News

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.

R&D

Regulatory setback or scientific signal? The case for human-...

Exploring a systemic challenge in translating biological promise into reliable human efficacy and safety.

News

Anavex sinks after pulling Alzheimer's filing in EU

Shares in Anavex Life Sciences lost more than a third of their value today after the company abandoned an EU filing for its Alzheimer's therapy.

News

ImmunityBio warned by FDA over 'misleading' Anktiva content

The FDA has sent a warning letter to ImmunityBio over "false and misleading" comments made by executive chair, billionaire Patrick Soon-Shiong.

Agios mulls early FDA filing for sickle cell therapy

Overcoming 6 data management challenges in flow cytometry

FDA points to liver injury with Amgen's Tavneos

Regulatory setback or scientific signal? The case for human-...

Anavex sinks after pulling Alzheimer's filing in EU

ImmunityBio warned by FDA over 'misleading' Anktiva content

Boehringer transfers schizophrenia DTx selling rights to Cli...

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

regulatory

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