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Clinical Hold on Neumora Study in Brain Diseases

[ Price : $8.95]

FDA places a clinical hold on a Neumora Therapeutics Phase 1 clinical trial for NMRA-266 for treating brain diseases.

Novartis Reports Favorable Data on Kidney Drug

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Novartis reports favorable data from a pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study of early kidney failure i...

FDA Clears 3D Printed Cranial Implant

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FDA clears a 3D Systems 510(k) for its 3D-printed, patient-specific cranial implant VSP PEEK Cranial Implant and its use in restor...

FDA Inspection Hits Zydus With Form-483

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FDA issues Zydus Lifesciences a four-item Form FDA-483 after inspecting the firms manufacturing facility (Matoda, Gujarat, India)....

Orphan Status for Ebola-like Vaccine

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FDA grants Soligenix an orphan drug designation for the active ingredient in MarVax vaccine against MARV infection.

HeartMate Pumps Recalled Due to Obstructions

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Abbotts Thoratec unit recalls its HeartMate II and HeartMate 3 Left Ventricular Assist System due to an issue called extrinsic out...

CDER Launches Trial Innovation Center

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CDER announces the launch of its Center for Clinical Trial Innovation, which will focus on promoting clinical trial innovation act...

Fresenius Recalls Infusion Pump Software

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Fresenius Kabi USA recalls (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that h...

Sun Gets OAI Inspection at India Facility

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FDA classifies a December inspection at Sun Pharmaceutical Industries Dadra, India facility as official action indicated.

Panel Backs Minimal Residual Disease Endpoint

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FDAs Oncologic Drugs Advisory Committee unanimously votes (12 to 0) that the totality of data are adequate to support the use of m...