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Blogs FDA Approval

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Editors   FDA: NeuralStem's Fetal Stem Cell Study for Lou Gehrig's Patients on Hold   2/25/2009 9:50:00 AM    Comment now FDA: NeuralStem's Fetal Stem Cell Study for Lou Gehrig's Patients on Hold
The US FDA put a hold on NeuralStem's clinical study amyotrophic lateral sclerosis, more commonly known as Lou Gehrig’s Disease.

The company had intended to test its ability to safely inject fetal stem cells into the spinal cords of patients and fully replace the damaged spinal cord cells.

See Editors   FDA Approves First Drug Made From Altered Animals   2/6/2009 11:59:00 AM    Comment now FDA Approves First Drug Made From Altered Animals
The US FDA approved the first drug, A Tryn made by GTC Biotherapeutics, made with materials from genetically engineered animals (goats), clearing the way for a new class of medical therapies.

The injectable drug will treat patients with a rare hereditary disorder to help prevent blood clots.
Editors   CBS News Feature on FDA Approval of World's First Embryonic Stem Cell Therapy   1/26/2009 1:03:00 PM    Comment now CBS News Feature on FDA Approval of World's First Embryonic Stem Cell Therapy
Teri Okita, CBS News, feature on January 23, 2009. World's first embryonic stem cell therapy on spinal cord patients.

Features an interview with Dr. Neil Theise of Beth Israel Medical Center discussing the hopes for embryonic stem cell treatments - heart disease, kidney disease, stroke patients, etc.
Editors   FDA Approves World's First Embryonic Stem Cell Therapy in Humans. Will They Walk Again?   1/23/2009 9:25:00 AM    Comment now FDA Approves World's First Embryonic Stem Cell Therapy in Humans. Will They Walk Again?
The FDA announced today that Geron Corp, a California biotechnology company, will perform the world's first embryonic stem cell (hESC) therapy on humans.

Geron will inject hESC cells directly into the damaged sites of paraplegic patients with spinal cord injuries in an effort to regrow ner...
Editors   FDA: Possibly First Ever Stem Cell Drug for FDA Approval   1/17/2009 11:31:00 AM    Comment now FDA: Possibly First Ever Stem Cell Drug for FDA Approval
Osiris Therapeutics (NASDAQ:OSIR) expects to have the first ever stem cell drug for FDA approval.

Prochymal would treat Graft vs. host disease, assisting bone marrow transplant patients to prevent the implanted marrow's immune cells from attacking the body.
Editors   First Human Trials for Stem Cell Therapy on Lou Gehrig Patients   12/18/2008 11:56:00 AM    Comment now First Human Trials for Stem Cell Therapy on Lou Gehrig Patients
The US FDA has cleared the way for Neuralstem, Inc. to conduct clinical trials on ALS (Lou Gehrig's disease) patients by injecting stem cells into their spinal cord.

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