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FDA blocks Astellas’ Claudin cancer drug over manufacturing

Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug can

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JPM: Four ways FDA is seeking to buoy gene therapy

On the outskirts of the JP Morgan Healthcare Conference today, FDA's Dr Peter Marks discussed how to get more gene therapies approved in 2024.

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Florida is first US state cleared to import Canadian drugs

The FDA has approved the first request from a US state to import prescription medicines from Canada, giving the green light to Florida for a programme that aims to reduce

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FDA holds back MSD’s chronic cough drug again

MSD will have to return to the drawing board to chart a course for US approval of its chronic cough treatment gefapixant.

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FDA elevates chief scientist Bumpus to the number two role

FDA chief scientist Namandjé Bumpus has been named as principal deputy commissioner, replacing long-serving Janet Woodcock when she steps down early next year.

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FDA launches wide probe into CAR-T therapy safety

The FDA has announced it will start an investigation into the safety of CAR-T therapies, after becoming concerned that they may be linked to the development of T-cell canc

FDA blocks Astellas’ Claudin cancer drug over manufacturing

JPM: Four ways FDA is seeking to buoy gene therapy

Florida is first US state cleared to import Canadian drugs

FDA holds back MSD’s chronic cough drug again

FDA elevates chief scientist Bumpus to the number two role

FDA launches wide probe into CAR-T therapy safety

Third Rock in $2bn drug-hunting pact with China's Funnel

Securing your ROI: Turning post-acquisition integration into...

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