FDA Warning Letter for Stem Cell and Placenta Products

by Devices and Pharma | Oct 27, 2026 | Biologics Warning Letters, Biologics-information, Stem Cells, US-FDA

Biologics Warning Letters Unapproved stem cell and placenta products Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation Contact FDA challenges claims that biological products can treat serious diseases without...

FDA Challenges Tides Medical’s Class I Device Classification

by Devices and Pharma | Oct 27, 2026 | Biologics Warning Letters, Biologics-information, Industry Information, Industry News, US-FDA

Biologics Warning Letters Claimed device classification not supported by intended use Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation Contact FDA’s warning letter to Tides Medical illustrates how a...

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...

FDA Approves First Gene Therapy for Genetic Hearing Loss

by Devices and Pharma | Apr 24, 2026 | Biologics-information, Gene Therapy, Industry Information, Industry News, Product-Innovation, Products_biologics, Products_Combination, Products_Devices

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 Gene Therapy for...

FDA Streamlines Biosimilar Development to Reduce Drug Costs

by Bruce Waldon | Mar 10, 2026 | Biologics-information, Biosimilars, FDA Approvals, FDA_Innovation, Product-Innovation, US-FDA

FDA Regulatory Innovation Streamlining the development of biosimilars Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact FDA...