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FDA Backs CellProthera Cell Therapy Phase 3 Study

[ Price : $8.95]

CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell...

Technical Modification for Device Malfunction Reporting

[ Price : $8.95]

Federal Register notice: FDA announces a minor technical modification to an alternative option that permits quarterly manufacturer...

Device Malfunction Summary Reporting Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for ...

J&J Files BLA for Myasthenia Gravis Therapy

[ Price : $8.95]

Johnson & Johnson files a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis.

FDA Publishes 2 Revised VICH Guidances

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FDA publishes two revised Veterinary International Conference on Harmonization guidances on validation of analytical procedures fo...

FDA Clears Thinks Robitic System for 2 Knee Implants

[ Price : $8.95]

FDA clears a Think Surgical 510(k) for the TMini Miniature Robotic System and its use with the GMK Sphere and SpheriKA Knee System...

Merck Discontinues 2 Keytruda Phase 3 Trials

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Merck says that on the recommendation of independent data monitoring committees, it is discontinuing a Keytruda lung cancer trial ...

Tandem Updates Apple Mobile Diabetes Pump App

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Tandem Diabetes Care says it is recalling an Apple app used with its t:slim insulin pump and replacing it with updated software.

CDER Creates Internal AI Council

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CDER creates a new internal Artificial Intelligence Council to oversee, coordinate, and consolidate all Center AI activities.

Nuvectis Gets Orphan Status for NXP800

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FDA grants Nuvectis Pharma an orphan drug designation for NXP800 and its use in treating ovarian, fallopian tube, and primary peri...