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FDA, Tonix Align on Lyme Disease Prevention Phase 2 Study

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FDA and Tonix Pharmaceuticals align on the protocol for an adaptive Phase 2 study of the companys TNX-4800 to prevent Lyme disease...

Inspection Flags Sterility and Quality Control Concerns at Zydus Lifesciences

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An FDA inspection cites multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturi...

FDA Approves Takedas Orzeyful for Narcolepsy Type 1

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FDA approves Takedas Orzeyful as the first drug to treat all symptoms of narcolepsy type 1 in adults.

Fresenius Recalls Morphine Injection Syringe Lot Due to Labeling Mix-Up

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Fresenius Kabi recalls one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a label...

Multiple Violations in Brunner Hygiene Unapproved New Drugs

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FDA warns Germanys Thomas Brunner Hygiene about CGMP and other violations in its production of unapproved and misbranded antipersp...

Jazz to Remove Zepzelca Second-Line Indication

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Jazz Pharma says it will seek FDA approval to remove Zepzelcas (lurbinectedin) second-line metastatic small cell lung cancer indi...

Allergan sBLA for Botox Accepted for Review

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FDA accepts for review an Allergan Aesthetics supplemental BLA for Botox Cosmetic (onabotulinumtoxinA) for the temporary improveme...

FDA Warns of High-Risk Issue With BD Intraosseous Needle Sets

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FDA issues an early alert warning healthcare providers not to use certain Becton Dickinson intraosseous vascular access needle set...

Liebel-Flarsheim Recalls Optiray Imaging Contrast Agent

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Liebel-Flarsheim recalls one lot of its Optiray Imaging Bulk Package 350 radiographic contrast agent after identifying particulate...

Electronic Common Document Updated Support Package Out

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The International Council for Harmonization says its electronic common technical document working group has issued updated support...