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Kezar Suspends Lupus Trial After 4 Deaths

[ Price : $8.95]

After four deaths were reported, Kezar Life Sciences suspends the enrollment of new patients and dosing of ongoing patients in its...

Device Performance Criteria for 4 Dental Devices

[ Price : $8.95]

Federal Register notice: FDA makes available four final device-specific guidance documents for the Safety and Performance Based Pa...

J&J Files sBLA for Darzalex Faspro

[ Price : $8.95]

Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication combinat...

Smiths Medical Recalls ParaPac Ventilators

[ Price : $8.95]

Smiths Medical recalls (Class 1 device correction) its ParaPAC Plus P300 and P310 Ventilators due to inadvertent tidal volume knob...

Germitecs Chronos Gets De Novo Marketing Pass

[ Price : $8.95]

FDA awards de novo marketing clearance to Germitecs Chronos automated disinfection device for reducing the risk of cross-contamina...

Guide on X-Ray Device Regulations

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Clarification of Radiation Control Regulations for Manufact...

FDA Discusses Optimizing Advisory Committees

[ Price : $8.95]

FDA commissioner Robert Califf and other top officials outline areas the agency believes can be optimized to help improve the advi...

FDA Approves Motiva Breast Implants

[ Price : $8.95]

FDA approves Establishment Labs Holdings Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants for breast augmen...

4 Dental Device Performance Criteria Guides

[ Price : $8.95]

CDRH posts four dental final guidances under its Performance Criteria for Safety and Performance Based Pathway program.

Dupixent Approved for COPD Add On

[ Price : $8.95]

FDA approves Sanofi and Regenerons Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled...