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Grace Therapeutics NDA for Hemorrhage Drug Submitted

[ Price : $8.95]

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

Limited Covid Vaccines OKd for Upcoming Season

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FDA approves supplemental BLAs from Moderna and Pfizer/BioNTech for their mRNA Covid-19 vaccines that target the LP.8.1 variant of...

Regeneron to Seek FDA OK for Myasthenia Gravis Drug

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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 ...