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Disqualify 2 Minnesota Researchers: Public Citizen

[ Price : $8.95]

Public Citizen says FDA should disqualify from conducting clinical trials two doctors at the Hennepin County Medical Center and th...

Fast Track for AstraZeneca Lokelma Indication

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FDA grants fast track designation to AstraZenecas hyperkalemia drug Lokelma to reduce arrhythmia-related cardiovascular outcomes i...

Changes for Electronic Submission Guidance

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Cook Group recommends improvements to an FDA draft guidance on the electronic submission eSTAR template.

Blackrock Neurotech Breakthrough Status for Brain Interface

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FDA grants Blackrock Neurotech a breakthrough device designation for its MoveAgain Brain Computer Interface System that is intende...

CytoDyn Resubmits Rolling BLA for HIV Therapy

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CytoDyn begins resubmitting a rolling BLA for leronlimab, a CCR5 antagonist used in combination therapy with highly active antiret...

MIDD Pilot Updated

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FDA says it is asking the Model-Informed Drug Development meeting requests and packages to include a credibility framework.

Scientists Ask How FDA Will Review New Alzheimer Drugs

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The journal Nature explores researchers questions about how FDA will act on two new amyloid-β therapies for Alzheimers diseas...

Improve FDA ClinicalTrials.gov Enforcement: Researchers

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Researchers say FDA and NIH could do more to enforce ClinicalTrials.gov reporting requirements.

De Novo Granted for Virtual Reality for Pain

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FDA authorizes the de novo marketing of AppliedVRs EaseVRx, a prescription-use immersive virtual reality system that uses cognitiv...

Medtronic PillCam At-Home Endoscopy

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FDA grants Medtronic 510(k) clearance for its PillCam Small Bowel 3 system for remote endoscopy procedures.