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FDA Authorizes NightWare Platform Marketing

[ Price : $8.95]

FDA gives de novo marketing authorization to the NightWare therapeutic platform to interrupt PTSD-associated nightmares.

Sebela Pharma Sutab Tablets OKd for Colon Prep

[ Price : $8.95]

FDA approves a Sebela Pharmaceuticals NDA for Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) tablets, indicated...

FDA Fast Track for Surface Oncology Liver Cancer Drug

[ Price : $8.95]

FDA gives fast track designation to Surface Oncologys SRF 388 investigational liver cancer drug.

Nanowears SimpleSense Undergarment Monitor Cleared

[ Price : $8.95]

FDA clears a Nanowear 510(k) for its cloth-based diagnostic platform SimpleSense, a multi-parameter remote diagnostic undergarment...

Lilly Gets EUA for Covid Antibody Treatment

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FDA grants Eli Lilly an emergency use authorization for its investigational monoclonal antibody therapy bamlanivimab for treating ...

CGMP Violations at Nartex Laboratories

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FDA warns Mexicos Nartex Laboratories about CGMP violations in its production of finished drugs.

Positive Trial Results for Amgens Tezepelumab

[ Price : $8.95]

Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive results in the Phase 3 NAVIGATOR trial.

Senators Want Info on FDA Foreign Drug Inspections

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Sens. Warren and Smith ask FDA for information on what it needs to adequately conduct foreign drug inspections during the pandemic...

Guide on Assessing Drug User Fees

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Federal Register notice: FDA makes available a revised final guidance on Assessing User Fees Under the Prescription Drug User Fee ...

Guide on Microneedling Product Regulatory Considerations

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Federal Register notice: FDA makes available a final guidance entitled Regulatory Considerations for Microneedling Products.