CBLB502 was granted Fast Track and Orphan Drug designations from the FDA for reducing the risk of or preventing death following total body irradiation during or after radiation disaster. The FDA Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Such programs include expanded communications (both verbal and written), rolling BLA submission and reviews, priority review (6 month action date instead of 10 month action date) and accelerated drug approval (approval on the basis of a surrogate endpoint).
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CBLI Breaking News
- ACT - Stem Cell Trial for AMD and Stargardt - Phase 1 [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Excerpt from: "The Urban Wire" Internet Radio Podcast: FDA Oks embryonic stem cell trials for humans [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Advanced Cell Technology (ACT) AMD stem cell clinical phase [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Stem Cells Retina and cornea regeneration ACT Dr lanza - Advanced Cell Technology [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Spinal Patient Receives Stem Cells in First Experimental Treatment [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Bloomberg: Geron, StemCells Rise 4% [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Bringing Stem Cell Cures to the Clinic: UC Davis GMP Facility [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Researchers in California Show Results for Spinal Cord Injuries Using Embryonic Stem Cells [Last Updated On: September 15th, 2011] [Originally Added On: September 15th, 2011]
- Bill Caldwell, Chairman [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- Advanced Cell Technology OneMedForum 2011 [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- ACT edmund vision stem cells program Advanced Cell Technology [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- Texans for Stem Cell Research Learn for Life: KXAN Coverage Aired August 16th, 2011 [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- ACT - Dr Lanza - Hermangioblast program - Advanced cell technology [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Anticipating the Next Decade of the Genome - Francis Collins, Director of NIH [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- New Epilepsy Treatment Under Study For Seizures - Part 1 [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- A Thank You For Trevor Raborn [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- What is Cord Blood Banking? The Medical Potential of Newborn Stem Cells [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Stem cell medical breakthrough? [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- NIST Colloquium Series: Next Generation Neural Implants [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Alan Lewis: Embryonic Stem Cell Therapies for diabetes [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- 2011 Predictions for Hair Transplant Developments | Arocha Hair Restoration [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Healthbeat - Stem Cell Research [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Living With ALS [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- A Revolutionary New Potential Treatment for Glioblastoma... [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Lyme Disease: Challenges and Innovations [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- 2010: Cord blood saving lives [CNN: 5-30-2011] [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Biotechnology, Diagnostics, and Genomics: Panel Discussion [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Pharmacogenomics [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Brickheads - Osteobots Practice Skit.mpg [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- A veteran lives with ALS [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
- Healthy Body = Functional Body. Hollywood Look Side Effect: Healthy Function [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
- 2009 Flu Summit: Opening Remarks [Last Updated On: September 26th, 2011] [Originally Added On: September 26th, 2011]
- Cord Blood Breakthrough [Last Updated On: September 28th, 2011] [Originally Added On: September 28th, 2011]
- SENS5 - Leucocyte transfusions as a novel immunotherapy for cancer patients [Last Updated On: October 2nd, 2011] [Originally Added On: October 2nd, 2011]
- Lymphoma Drug SGN-35 - The Nebraska Medical Center [Last Updated On: October 2nd, 2011] [Originally Added On: October 2nd, 2011]
- ACell Hair Restoration with Dr. Gary Hitzig and Dr. Amiya Prasad - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- Hans Keirstead: Developing therapies based on embryonic stem cells - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- NJN News Healthwatch Report - Cornea Treatment Study - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- HIV/AIDS may be prevented by new lubricant - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- MFIII Switzerland PE Sheep Placenta Glandular therapy Study - Client Interviews - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- Love Diabetes: BCG and Noncompliant Patients - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- Dr. Alimorad Farshchian statement on embryonic stem cells - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- StemCellTV Daily Report-October 29, 2011 - Video [Last Updated On: October 30th, 2011] [Originally Added On: October 30th, 2011]
- Stephen McKenna MD - 8 - Video [Last Updated On: October 31st, 2011] [Originally Added On: October 31st, 2011]
- ALS Stem Cell Trial at Emory - Video [Last Updated On: November 22nd, 2011] [Originally Added On: November 22nd, 2011]
- Target Product Profile: Ellen Feigal - 2011 CIRM Grantee Meeting - Video [Last Updated On: December 6th, 2011] [Originally Added On: December 6th, 2011]
- Monoclonal Antibodies: Stanford Academia-Industry Collaboration - Video [Last Updated On: December 8th, 2011] [Originally Added On: December 8th, 2011]
- Parkinson's Disease Guidelines (Part 2) - Video [Last Updated On: December 9th, 2011] [Originally Added On: December 9th, 2011]
- Macular Degeneration Drugs - Video [Last Updated On: December 13th, 2011] [Originally Added On: December 13th, 2011]
- BrainStorm Cell Therapeutics (OTCBB:BCLI) Has Potentially Developed A Treatment For ALS [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- StemCells, Inc. Receives FDA Authorization for Age-Related Macular Degeneration Clinical Trial [Last Updated On: February 3rd, 2012] [Originally Added On: February 3rd, 2012]
- Stemedica Cell Technologies - Documentary - Video [Last Updated On: February 4th, 2012] [Originally Added On: February 4th, 2012]
- (GMCR, STEM, DSCO) CRWENewswire.com Stocks In Action - Video [Last Updated On: February 7th, 2012] [Originally Added On: February 7th, 2012]
- Bioheart Acquires Exclusive Rights to Ageless Regenerative Institute's Adipose Cell Technology [Last Updated On: February 14th, 2012] [Originally Added On: February 14th, 2012]
- Neuralstem Announces Closing of $5.2-Million Registered Direct Offering [Last Updated On: February 14th, 2012] [Originally Added On: February 14th, 2012]
- Scientists Repair Heart Attack Damage Using Patient's Own Stem Cells To Regrow Healthy Heart Muscle [Last Updated On: February 14th, 2012] [Originally Added On: February 14th, 2012]
- Stem Cells Regrow Healthy Heart Muscle In Heart Attack Patients [Last Updated On: February 15th, 2012] [Originally Added On: February 15th, 2012]
- Groundbreaking Clinical Trials Study Cord Blood Stem Cells to Help Treat Brain Injury and Hearing Loss [Last Updated On: February 17th, 2012] [Originally Added On: February 17th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Lung Cancer Trial With I-124-CLR1404 (Light) Cancer ... [Last Updated On: February 22nd, 2012] [Originally Added On: February 22nd, 2012]
- IntelliCell BioScience Inc. Procedure Enables Norwegian Star Basketball Player to Fully Recover from Patella ... [Last Updated On: February 22nd, 2012] [Originally Added On: February 22nd, 2012]
- The Lancet Publishes Results from Gentium's Phase III Defibrotide Trial for the Prevention of VOD in Paediatric Patients [Last Updated On: February 27th, 2012] [Originally Added On: February 27th, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress and New Initiatives [Last Updated On: March 1st, 2012] [Originally Added On: March 1st, 2012]
- Bioheart Issues Shareholder Letter Announcing Progress [Last Updated On: March 1st, 2012] [Originally Added On: March 1st, 2012]
- Novelos Therapeutics and Academic Collaborators Have Three Abstracts Accepted for Presentation at 2012 AACR Annual ... [Last Updated On: March 1st, 2012] [Originally Added On: March 1st, 2012]
- Marshall Edwards Submits Investigational New Drug Application for Oncology Drug Candidate ME-344 [Last Updated On: March 6th, 2012] [Originally Added On: March 6th, 2012]
- Will StemCells Walk The Talk? [Last Updated On: March 7th, 2012] [Originally Added On: March 7th, 2012]
- Internationally Recognized Leukemia Physician and Researcher to Lead Sylvester Comprehensive Cancer Center [Last Updated On: March 7th, 2012] [Originally Added On: March 7th, 2012]
- Criminal investigation after patient dies at office of doctor linked to stem cell [Last Updated On: March 9th, 2012] [Originally Added On: March 9th, 2012]
- Novelos Therapeutics Announces Enrollment of First Patient in Brain Cancer Trial with I-124-CLR1404 (LIGHT) Cancer ... [Last Updated On: March 15th, 2012] [Originally Added On: March 15th, 2012]
- Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy [Last Updated On: March 20th, 2012] [Originally Added On: March 20th, 2012]
- Looking for Innovative Small-Cap Biotech Companies: George Zavoico [Last Updated On: March 26th, 2012] [Originally Added On: March 26th, 2012]
- Seattle Genetics Announces Pivotal ADCETRIS™ (Brentuximab Vedotin) Hodgkin Lymphoma Study Published in Journal of ... [Last Updated On: March 27th, 2012] [Originally Added On: March 27th, 2012]
- Gentium Reports Fourth Quarter and Year End 2011 Financial Results [Last Updated On: March 28th, 2012] [Originally Added On: March 28th, 2012]
- Basketball’s influence on stem cell treatments in sports medicine [Last Updated On: March 30th, 2012] [Originally Added On: March 30th, 2012]
- Cardium Announces U.S. Market Introduction of Excellagen™ [Last Updated On: March 31st, 2012] [Originally Added On: March 31st, 2012]
- Optimer Pharmaceuticals, Inc. Announces Presentation at ECCMID of Post-Hoc Subgroup Analysis of DIFICID in Adult ... [Last Updated On: March 31st, 2012] [Originally Added On: March 31st, 2012]
- New Data Demonstrates DIFICLIR™ May Offer Benefits for Cancer Patients, who are at High Risk of Clostridium Difficile ... [Last Updated On: April 1st, 2012] [Originally Added On: April 1st, 2012]
- SynGen Inc. Receives $5 million Equity Investment from Bay City Capital, LLC [Last Updated On: April 19th, 2012] [Originally Added On: April 19th, 2012]
- Gene Ray, Founder of $2.6 Billion Titan Corp, Invests in Medistem's ERC Technology and Joins Advisory Board [Last Updated On: April 26th, 2012] [Originally Added On: April 26th, 2012]
- Small Biotech Companies Look to Benefit From Shift to "First to File" Patent System [Last Updated On: May 4th, 2012] [Originally Added On: May 4th, 2012]