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Probation for Unapproved Drug Distribution Conspiracy

[ Price : $8.95]

The Justice Department says a Georgia man has been sentenced to five years probation for conspiracy to distribute unapproved drugs...

EUA for Vir/GSK Covid Antibody Treatment

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FDA grants an EUA for Sotrovimab, a monoclonal antibody treatment for Covid-19 developed by Vir Biotechnology and GlaxoSmithKline.

Justice Department Hits Eli Lilly with Subpoena

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U.S. Department of Justice issues a subpoena to Eli Lilly requesting documents about its troubled manufacturing site in Branchburg...

FDA Approves Progenics Pylarify for Prostate Cancer Imaging

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FDA approves Progenics Pharmaceuticals Pylarify for PET imaging of prostate-specific membrane antigen positive lesions in some men...

Metro Drugs Sterile Drug Deficiencies Noted

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FDA cautions New York Citys Metro Drug about adulterated and misbranded sterile drug products.

Transition from Non-Approved Disposable Respirators: FDA

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FDA says healthcare personnel and facilities can transition away from using non-NIOSH-approved disposable respirators due to an in...

Acutus Medical Atrial Fibrillation Trial Gets Go Ahead

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FDA gives Acutus Medical the green light to initiate its atrial fibrillation clinical trial to assess the AcQBlate Force Sensing A...

FDA Priority Review for Janssen Myeloma BLA

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FDA accepts for priority review a Janssen BLA for an investigational treatment for relapsed/refractory multiple myeloma.

FDA Issues 2 Draft Device Surveillance Guidances

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FDA publishes two draft guidances on the continued surveillance of certain FDA-approved and cleared medical devices.

Covid-19 Related Guidances Listing Updated

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Federal Register notice: FDA announces the availability of FDA guidance documents related to the Covid-19 pandemic.