October 2026 FDA Premarket Notification Clearances

by Devices and Pharma | Nov 2, 2026 | FDA Clearances, Med-Devices, Product-Innovation, Reg_Information, Regulatory_Info, Regulatory_Intel, US-FDA

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FDA Approves Voceryq, First Plasmid DNA Immunotherapy

by Devices and Pharma | Nov 2, 2026 | Biologics-information, New Biologics

FDA Approves Voceryq, First Plasmid DNA Immunotherapy Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts...

FDA Clears AI Software for Automated Kidney Volume Assessment

by Devices and Pharma | Oct 29, 2026 | FDA Approvals, Industry Information, Industry News, Med-Devices, New devices, Product-Innovation, Products_Devices, Reg_Products, Renal, US-FDA

Medical Device Innovation Aramis Global AI's Automated Kidney Volume Assessment Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central...

FDA Approves SELUTION SLR Drug-Eluting Balloon

by Devices and Pharma | Oct 29, 2026 | Cardiovascular, FDA Approvals, Industry Information, Industry News, Med-Devices, New devices, Product-Innovation, Products_Combination, Products_Devices, US-FDA

Medical Device Innovation MedAlliance's SELUTION SLR drug-eluting balloon Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News...

First T-Cell Therapy to Reduce Disease after Cell Transplant

by Devices and Pharma | Jul 31, 2026 | Cell Therapy, FDA Approvals, Gene Therapy, Industry Information, Industry News, New Biologics, Products_biologics, Stem Cells, T-Cell Therapy

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Approves First Regulatory T-Cell...

Casgevy Gene Therapy Expanded to 2-Year-Old Children

by Devices and Pharma | Jul 16, 2026 | FDA Public Information, FDA_Innovation, Gene Therapy, Gene Therapy, Industry Information, Industry News, Products_biologics

Home About Consumer News Food and Beverage Supplements Cosmetics Regulatory Medical Devices Pharma Biologics Combination Products In Vitro Diagnostics Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA Expands Casgevy Gene Therapy...