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Regeneron to Seek FDA OK for Myasthenia Gravis Drug

[ Price : $8.95]

Regeneron Pharmaceuticals releases favorable Phase 3 data for its RNA-based therapy cemdisiran and says it will seek FDA approval ...

Lilly Plans NDA for Obesity Pill; Positive Data Released

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Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Pha...

QS Violations at LeMaitre Vascular

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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

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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...