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2. FDA sends warning to company for marketing dangerous unapproved...

   www.fda.gov/news-events/press-announcements/fda-sends...

   The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant ...

3. FDA acts to remove unproven, potentially harmful treatment used...

   www.fda.gov/news-events/press-announcements/fda-acts...

   As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment.

4. FDA Approves Cell Therapy for Patients with Blood Cancers to...

   www.fda.gov/news-events/press-announcements/fda-approves...

   Stem cell transplantation is a common treatment for blood cancers. It involves putting healthy stem cells into the body to help restore the normal production and function of blood cells.

5. Innovative Regenerative Medicine Therapies – Safety Comes First

   www.fda.gov/news-events/fda-voices/innovative-regenerative...

   The US Stem Cell decision is a victory for public health and an endorsement of the FDA’s work to stop stem cell clinics that place patients at risk by marketing products that violate the law.

6. Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s...

   www.fda.gov/news-events/press-announcements/statement-fda...

   FDA warns US Stem Cell Clinic of significant deviations; FDA acts to remove unproven, potentially harmful treatment used in a stem cellâ centers targeting vulnerable patients

7. Consumer Alert on Regenerative Medicine Products Including Stem...

   www.fda.gov/vaccines-blood-biologics/consumers-biologics/...

   Healthcare professionals and consumers should report any adverse events related to the use of stem cells, exosomes, or other products purported to be regenerative medicine products to the FDA’s ...

8. Potential Risks with Unapproved Regenerative Medicine Products

   www.fda.gov/news-events/fda-voices/potential-risks...

   FDA is providing additional resources to help consumers understand the risks associated with unapproved stem cell, exosome, and other products marketed as regenerative medicine products.

9. FDA’s Role in Veterinary Regenerative Medicine | FDA - U.S. Food...

   www.fda.gov/animal-veterinary/cell-and-tissue-products...

   Examples include animal stem cells, differentiated cells, and tissues such as blood, platelet-rich plasma, and amnion.

10. Federal court issues decision holding that US Stem Cell clinics...

    www.fda.gov/news-events/press-announcements/federal-court...

    “In the case against US Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings.

11. FDA Warns About Stem Cell Therapies | FDA - U.S. Food and Drug...

    www.fda.gov/consumers/consumer-updates/fda-warns-about...

    The U.S. Food and Drug Administration is concerned that some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. Here's what to know before you consider ...