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Human Drugs

FDA Looking at MASH Surrogate

FDA says it has accepted an Echosens Letter of Intent to develop Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a surro...

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Human Drugs

Grace Therapeutics NDA for Hemorrhage Drug Submitted

FDA accepts for review a Grace Therapeutics NDA for GTx-104 (nimodipine for injection) for treating patients with aneurysmal subarachnoid hemorrhage.

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Human Drugs

Regeneron to Seek FDA OK for Myasthenia Gravis Drug

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

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Human Drugs

Lilly Plans NDA for Obesity Pill; Positive Data Released

Eli Lilly plans to seek approval for its investigational obesity pill orforglipron following positive topline results from the Phase 3 ATTAIN-2 trial....

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Medical Devices

QS Violations at LeMaitre Vascular

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

Human Drugs

Allaritys Stenoparib on FDA Fast Track

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

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Biologics

Axogen Nerve Graft Review Extended by 3 Months

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

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Medical Devices

11 QS, MDR Violations at Miach Orthopaedics

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

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Human Drugs

BIO September Congressional Priorities

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

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Human Drugs

Multiple GLP Violations at Chinas Jiangsu Kerbio

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