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Astellas refiles CLDN 18.2 cancer drug after FDA knockback

The US FDA has started a fresh review of Astellas' zolbetuximab, trying to become the first claudin (CLDN) 18.2-targeting drug to reach the US market, after turning it dow

R&D

parental permission, child assent, and consent in clinical trials

Parental permission, child assent, and adolescent autonomy i...

As a vulnerable population, children in general must rely on their parents or guardians to provide informed consent for them to participate in research.

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FDA competition seeks digital endpoints for Parkinson’s

The FDA is asking digital health technology developers to come up with a solution to measuring a common symptom of Parkinson’s disease that can have a serious impact on pa

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FDA delays decision on Moderna’s RSV vaccine

Moderna’s first attempt to expand its commercial activities beyond COVID-19 vaccines, its respiratory syncytial virus (RSV) shot, has suffered a delay in the US.

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FDA sets June adcomm date for Lilly’s Alzheimer’s drug

The FDA has confirmed that it will convene an advisory committee meeting on 10th June to discuss Eli Lilly’s Alzheimer’s disease candidate donanemab, after announcing a de

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Apple gets FDA okay to use AFib tool in clinical trials

The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduce

Astellas refiles CLDN 18.2 cancer drug after FDA knockback

Parental permission, child assent, and adolescent autonomy i...

FDA competition seeks digital endpoints for Parkinson’s

FDA delays decision on Moderna’s RSV vaccine

FDA sets June adcomm date for Lilly’s Alzheimer’s drug

Apple gets FDA okay to use AFib tool in clinical trials

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

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

FDA

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