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QS Violations at LeMaitre Vascular

[ Price : $8.95]

FDA warns North Brunswick, NJ-based LeMaitre Vascular about Quality System Regulation and other violations in its manufacturing of...

Allaritys Stenoparib on FDA Fast Track

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FDA grants fast track designation to Allarity Therapeutics investigational ovarian cancer drug stenoparib.

Axogen Nerve Graft Review Extended by 3 Months

[ Price : $8.95]

FDA extends by three months its review of an Axogen BLA for Avance Nerve Graft after the agency determined that information submit...

11 QS, MDR Violations at Miach Orthopaedics

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FDA warns Westborough, MA-based Miach Orthopaedics about eight Quality System and three Medical Device Reporting violations in its...

BIO September Congressional Priorities

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The Biotechnology Innovation Organization says its congressional lobbying priorities for September are reauthorization of the FDA ...

Multiple GLP Violations at Chinas Jiangsu Kerbio

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FDA warns Chinas Jiangsu Kerbio Technology Group Co. about its violations of good laboratory practice regulations for nonclinical ...

FDA Breakthrough Status for Lupis Blood Purifier

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FDA grants Santersus a breakthrough device designation for its NucleoCapture blood purification system for patients with severe, t...

Inovio Begins Rolling BLA for Rare Throat Disorder

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Inovio Pharmaceuticals begins a rolling BLA submission for INO-3107, an experimental DNA medicine for recurrent respiratory papill...

Chikungunya Vaccine Suspended Due to Safety Concerns

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CBER suspends Valneva Austrias BLA for Ixchiq (chikungunya vaccine, live) due to serious safety concerns related to the vaccine.

FDA Study: CBD Linked to Elevated Liver Enzymes

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An FDA clinical trial finds that daily use of cannabidiol at levels typically used by consumers can cause elevated liver enzymes i...