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Supernus Parkinsons Off Episodes NDA Refiled

[ Price : $8.95]

FDA accepts for review a Supernus Pharmaceuticals NDA resubmission for its apomorphine infusion device (SPN-830) for the continuou...

Guide on Clinical e-Thermometer

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Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.

Empatica Adds 2 Biomarkers to Monitoring Device

[ Price : $8.95]

FDA clears an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform pulse and respiratory ra...

House GOPers Concerned About FDA Lab Safety

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Republican members of the House Energy and Commerce Committee express concern about FDA inaction on the safety of agency laborator...

Hold on Nurix B-cell Malignancies Study

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A transition to an improved manufacturing process leads to an FDA partial clinical hold on a Nurix Therapeutics clinical study eva...

Patient Engagement Panel Renewal

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Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expir...

Harvard Drug Group Recalls Eye Drops

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The Harvard Drug Group recalls all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (dextran/...

FDA/Moderna Revolving Door Analyzed

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A BMJ investigation looks at the case of two former FDA vaccine officials who now work for Moderna.

Lilly Sees Alzheimers Drug Decision Delay

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Eli Lilly says that an FDA review decision for its experimental Alzheimers drug donanemab has been pushed back to the first quarte...

Clinical e-Thermometer Enforcement Policy

[ Price : $8.95]

FDA posts a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.