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FDA makes acting CDER, CBER chiefs permanent

Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.

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FDA issues warning letters to five unapproved GLP-1 websites

In a handful of strongly-worded warning letters, the FDA is cracking down on sales of unapproved peptides - even if they're labelled for research.

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A COVID jab held in hands wearing surgical gloves

FDA approves new COVID shots - with same restrictions as las...

FDA has approved the 2026 COVID vaccine formulations, but last year's narrower recommendation stands, leaving open questions about access.

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Jazz secures FDA approval for Ziihera in first-line HER2-pos...

Jazz Pharmaceuticals has been granted US approval for two combinations of its cancer drug Ziihera HER2+ advanced GEA.

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The puzzle of Alzheimer's, HCP hand holds digital graphic of brain and missing puzzle piece

Neurocrine receives FDA IND Acceptance for Alzheimer’s Ph2

Nxera Pharma has announced that partner Neurocrine Biosciences has received IND Acceptance from the FDA a Ph2 of NBI-1117567 in Alzheimer's cognition.

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FDA issues novel nods for diabetes monitor, migraine lenses

In a busy week, the FDA granted two De Novo authorisations for consumer health devices and is rumoured to be mulling structural leadership changes.

FDA makes acting CDER, CBER chiefs permanent

FDA issues warning letters to five unapproved GLP-1 websites

FDA approves new COVID shots - with same restrictions as las...

Jazz secures FDA approval for Ziihera in first-line HER2-pos...

Neurocrine receives FDA IND Acceptance for Alzheimer’s Ph2

FDA issues novel nods for diabetes monitor, migraine lenses

Telix to buy radiopharma rival ITM for $1.65bn upfront

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

FDA

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