FDA

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The FDA has turned down Pharming's bid to broaden the label of Joenja for rare immunodeficiency disorder APDS so it can be used in younger patients.

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The FDA has started accepting requests to participate in its PreCheck pilot programme, promising rapid reviews of new manufacturing facilities.

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The FDA and EMA have come up with guiding principles that they say will underpin future guidance on the use of AI technologies in drug development.

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The FDA has asked manufacturers of GLP-1 drugs used for weight loss to remove warnings of suicidal thinking, but added warnings to flu shots.

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FDA wants to exert regulatory flexibility on cell and gene therapies in an effort to bring them to patients more quickly and efficiently.

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Vanda will continue to push for approval of Hetlioz for jet lag, despite the FDA saying its trial designs were not satisfactory.