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FDA OKs Bavarian Nordics Vaccine Facility

[ Price : $8.95]

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

Non-Curative Setting Available Therapy

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

Viz.ai Subdural Hemorrhage Detector Cleared

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

Additional Benlysta Indication Approved

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

CGMP Violations in Bi-Coastal Pharma Inspection

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

API Deviations Found at Jost Chemical

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

Immuron Gut Drug on Clinical Hold

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

iRhythm AI ECG Algorithm Cleared for Zio Watch

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

Regulatory Review Period for Vumerity

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alkermes Vumerity (diroxime...

EUA Revoked on Veklury After sNDA Approved

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Federal Register notice: FDA revokes the Emergency Use Authorization issued to Gilead Sciences for Veklury (remdesivir) for treati...