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Biologics

BioMarin Filing Additional Data for Hemophilia Gene Therapy

BioMarin Pharmaceutical says it is submitting to FDA additional long-term data (three years) as part of the ongoing BLA review for Roctavian (valoctoc...

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Medical Devices

Troubled Zyno Pays $493K over False Claims

Zyno Medical agrees to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare invol...

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Federal Register

Info Collection on Animal Minor Use/Species

Federal Register notice: FDA sends to OMB an information collection extension entitled Reporting Associated with Designated New Animal Drugs for Minor...

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Federal Register

Cell/Tissue Manufacturing Deviation Reporting

Federal Register notice: FDA sends to OMB an information collection extension entitled Cellular and Tissue-Based Product Deviations in Manufacturing; ...

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Biologics

Review extension for Krystal Gene Therapy BLA

FDA extends by three months a Krystal Biotech BLA for B-Vec (beremagene geperpavec) after it submitted manufacturing data pursuant to an agency inform...

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Human Drugs

Otsuka/Lundbeck sNDA for Alzheimers Agitation

FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for brexpiprazole for use in treating agitation associated w...

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Federal Register

Panel Meeting on Non-Rx Narcan

Federal Register notice: FDA announces a 2/15 advisory committee meeting to discuss an Emergent BioSolutions supplemental NDA for Narcan (naloxone HCl...

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Medical Devices

CardiacSense Vital Signs Watch Cleared by FDA

FDA clears a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rate, and oxygen satura...

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Human Drugs

Roche Priority Review BLA for B-cell Lymphoma

FDA accepts a Roche BLA for priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody for treating certain adult...

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Biologics

Cavazzoni Tries to Repair Credibility with New Alzheimers OK

CDER director Patrizia Cavazzonitries to restore credibility within her Center by announcing the accelerated approval for a Biogen/Eisai BLA for lecan...