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Human Drugs

Cassava Sciences Under Criminal Investigation: Reuters

Reuters reports that the Department of Justice has opened a criminal investigation into Cassava Sciences over allegations it manipulated results in a ...

Biologics

FDA OKs Bavarian Nordics Vaccine Facility

FDA approves Bavarian Nordics fill and finish facility in Denmark to manufacture its Jynneos smallpox/monkeypox vaccine.

Human Drugs

Non-Curative Setting Available Therapy

FDA publishes a guidance with recommendations on including patients who have not received available therapy in non-curative settings.

Medical Devices

Viz.ai Subdural Hemorrhage Detector Cleared

FDA clears a Viz.ai 510(k) for its Viz Subdural (SDH), an algorithm that uses artificial intelligences to automatically detect subdural hemorrhages.

Human Drugs

Additional Benlysta Indication Approved

FDA approves an additional indication for GlaxoSmithKlines Benlysta to treat children with active lupus nephritis who are receiving standard therapy.

Human Drugs

CGMP Violations in Bi-Coastal Pharma Inspection

FDA warns Shrewsbury, NJ-based Bi-Coastal Pharma International about CGMP violations in its manufacturing of finished drugs.

Human Drugs

API Deviations Found at Jost Chemical

FDA warns St. Louis, MO-based Jost Chemical Co. about CGMP deviations in its production of active pharmaceutical ingredients.

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Human Drugs

Immuron Gut Drug on Clinical Hold

FDA places a clinical hold on an unidentified Immuron investigational drug being evaluated for treating campylobacter and enterotoxigenic escherichia ...

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Medical Devices

iRhythm AI ECG Algorithm Cleared for Zio Watch

FDA clears an iRhythm Technologies 510(k) for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch.

Federal Register

Regulatory Review Period for Vumerity

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alkermes Vumerity (diroximel fumarate), indicat...