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Allure Imports Selling Unapproved, Misbranded Covid-19 Drugs: FDA

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FDA warns Allure Imports that it is marketing unapproved and misbranded drugs for use in humans or animals for Covid-19 indication...

NIA Researchers Look to Repurpose Drugs to Help Dementia

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National Institute on Aging researchers say they are evaluating whether drugs FDA approved for other indications could be repurpos...

Court Rejects Res Ipsa in Breast Implant Case: Attorney

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Attorney Andrew Tauber says a New Jersey federal court reiterated that plaintiffs in medical device manufacturing defect cases can...

Lawyers Analyze Hot-Button Special Counsel Letter

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Two Mintz attorneys see the potential for congressional hearings into FDAs handling of a Team Biologics whistleblower complaint al...

2 New Device Single Audit Program Training Modules Posted

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CDRH posts two new training modules for aspects of the Medical Device Single Audit Program.

AbbVie sBLA for Skyrizi in Psoriatic Arthritis

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AbbVie submits a supplemental BLA for Skyrizi (risankizumab-rzaa) 150 mg for treating adults with active psoriatic arthritis.

WuXi Biologics Completes 2 FDA Inspections

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WuXi Biologics says it passed two FDA inspections at its facility in China, perhaps signaling an increase in agency foreign inspec...

JAK Inhibitor Concerns Delay Lilly & Pfizer Submissions

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Ongoing FDA safety concerns with JAK inhibitors lead to review extensions for Eli Lilly/Incyte and Pfizer submissions.

Advisory Committee Supports TransMedics OCS Heart System

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Members of the FDA Circulatory Systems Device Advisory Panel vote to support the benefits, efficacy, and safety of the TransMedics...