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C&T Dream Co. CGMP Violations

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FDA warns South Koreas C&T Dream Co. about CGMP violations in its manufacturing of finished drugs.

New CDRH Dataset for Chemical Characterization

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FDA launches a new public dataset to help chemistry labs ensure the robustness of chemical characterization methods used to assess...

GSK BLA Accepted for Meningococcal Vaccine

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FDA accepts for review a GSK BLA for its 5-in-1 meningococcal ABCWY vaccine candidate.

Clinical Hold on Neumora Study in Brain Diseases

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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...