Navigation Links
Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review
Date:5/8/2009

EXTON, Pa., May 8 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (NYSE Amex: ILE) today announced that the United States Food and Drug Administration ("FDA") has completed its initial review of the Company's Biologics License Application ("BLA") related to its Nasolabial Fold/Wrinkles product candidate and that the FDA has accepted (or filed) the BLA for full review.

In a communication received from the FDA on May 7, 2009, the FDA noted that it had completed its initial review of the Company's BLA to determine its acceptability for filing and that the FDA has filed the Company's application. The FDA noted that its review completion target date is January 4, 2010.

The FDA's filing review is only a preliminary review, and deficiencies may be identified during full review of the BLA. Also, the acknowledgment of filing by the FDA does not mean that the FDA has issued a license, nor did the FDA represent any evaluation of the adequacy of the data submitted.

About Isolagen, Inc.

Isolagen(TM), Inc. (NYSE Amex: ILE) is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies. The company's technology platform includes the Isolagen Process(TM), a cell processing system for skin and tissue rejuvenation which is currently in clinical development for a broad range of aesthetic and therapeutic potential applications including wrinkles, acne scars, burns and periodontal disease. Isolagen also commercializes a scientifically-advanced line of skincare systems through its majority-owned subsidiary, Agera(R) Laboratories, Inc. For additional information, please visit www.isolagen.com.
'/>"/>

SOURCE Isolagen, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
2. Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
3. Rendell Administration Announces Health Research Grants From Tobacco Settlement Funds
4. ISTA Pharmaceuticals New Drug Application for Bepreve(TM) Accepted for Review by U.S. Food and Drug Administration
5. ImQuest Submits Investigational New Product Application to the Food and Drug Administration to Initiate HIV Therapeutic Clinical Trials with IQP-0410
6. Oramed Pharmaceuticals Chosen to Present Results of GLP-1 Analog Enteral Administration Study at the Diabetes Technology Societys Eighth Annual Meeting (November 13-15, 2008; Bethesda, Maryland)
7. Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD
8. New AAHC Toolkit Available to Optimize Clinical Research Administration
9. New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
10. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
11. Genmab A/S - Company Announcement Ofatumumab in Subcutaneous Study in Rheumatoid Arthritis Summary: Subcutaneous Administration of Ofatumumab Investigated in Phase I/II Study

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/25/2009)....,Nov.25/PRNewswire/--PraxisElectronicMedicalRecor...FamilyPhysicians,(AAFP)FamilyPracticeManagement(FP...quality,healthmaintenance,anddiseasemanagement,all...nked#1amongdoctorsindicatingtheirEMRhadapositiveef...kednumberoneinthecountryinprovidingexcellenttraini...
(Date:11/25/2009)...ov.25/PRNewswire-FirstCall/--Pharmasset,Inc.(Nasda...ttedtodiscovering,developingandcommercializingnove...ltsforthefiscalyearendedSeptember30,2009.AtSeptemb...valentsandshortterminvestments. ,, PipelineUpd...2bTrial ,, InlateNovember2009,anindependentDa...
(Date:11/25/2009)...,Nov.25/PRNewswire/--TheFDAgrantedtraditionalappro...eosidereversetranscriptaseinhibitor(NNRTI).INTELEN...ment-experiencedadultswhoareexperiencingvirologicf...tiretroviral(ARV)agents.Thetraditionalapprovalisba...ndDUET-2.INTELENCEiscurrentlymarketedintheU.S.byTi...
Breaking Medicine Technology:Praxis EMR Wins Top Rankings in 2009 AAFP EHR User Satisfaction Survey 2Pharmasset Reports Fiscal Year End 2009 Financial Results 2Pharmasset Reports Fiscal Year End 2009 Financial Results 3Pharmasset Reports Fiscal Year End 2009 Financial Results 4Pharmasset Reports Fiscal Year End 2009 Financial Results 5Pharmasset Reports Fiscal Year End 2009 Financial Results 6Pharmasset Reports Fiscal Year End 2009 Financial Results 7Pharmasset Reports Fiscal Year End 2009 Financial Results 8U.S. Food And Drug Administration (FDA) Grants Traditional Approval for INTELENCE(R) (etravirine) 2U.S. Food And Drug Administration (FDA) Grants Traditional Approval for INTELENCE(R) (etravirine) 3U.S. Food And Drug Administration (FDA) Grants Traditional Approval for INTELENCE(R) (etravirine) 4PAREXEL International to Present at Thomas Weisel Partners Healthcare Conference 13893 1PAREXEL International to Present at Thomas Weisel Partners Healthcare Conference 13893 2DuPont Leader Says Increasing Food Production a Moral Imperative 13891 1DuPont Leader Says Increasing Food Production a Moral Imperative 13891 2DuPont Leader Says Increasing Food Production a Moral Imperative 13891 3Gerber Life Medicare Supplement Now Available Through Precision Senior Marketing 56382 1Gerber Life Medicare Supplement Now Available Through Precision Senior Marketing 56382 2
...ion Pharmaceuticals, Inc. (Nasdaq: TRBN ) announ...SCORPION(TM) multispecific therapeutic technology ...ation of Cancer Research (AACR) in Denver, April 1...gi-bin/prnh/20090320/TRUBIONLOGO ) , , The compan...and high potency of the bispecific CD79BxDR SCORPI...
...ands, April 16 The European,Association of Urolog...ientific information on randomised screening studi.... Based on the results of the European Randomised,...e EAU has formulated a,position statement regardin...sequent actions to be taken by health professional...
Other Medicine Technology:Trubion Pharmaceuticals, Inc. Announces Upcoming Presentation at the 2009 American Association of Cancer Research Annual Meeting 2Trubion Pharmaceuticals, Inc. Announces Upcoming Presentation at the 2009 American Association of Cancer Research Annual Meeting 3EAU Position Statement on Screening for Prostate Cancer 2
(Date:11/25/2009)...,, KANSASCITY,Mo.,Nov.25/PRNewswire/--TheBartle...,slargestmedicalcliniconDec.9-10,whenKansasCityhos...edpeople. ,, "Thisfreecliniceventhasthepotentia...ysinsteadofjustoneandbeheldonweekdaysinsteadofover...tyFreeHealthClinicandpresidentoftheNationalAssocia...
(Date:11/25/2009)...,, TORONTO,Nov.25/PRNewswire/-SentinelleMedical...edvisualizationsoftwarelaunchesasuiteofnewleadinge...gsoftwareplatformatthisyear,sRadiologicalSocietyof...c.5,2009(Booth5800,HallA).Theapplicationsleveraget...ecializedMRIimagingcoilsandsupportmultipleimagingm...
(Date:11/25/2009)...,, LOSANGELES,Nov.25/PRNewswire-USNewswire/--Th...tionstodetermineexecutiveleadershipfor2010. ,, ...ithspecialtiesinpublicpolicy,law,finance,governmen...hip.TheBoardalsocomesfromawiderangeofpersonalbackg...men,somelivingwithHIVthemselves,andrepresentingmul...
(Date:11/25/2009)...Long-term survivors of testicular cancer who were ... severe side effects, including neurological side ...ere not treated with chemotherapy, according to a ...rnal of the National Cancer Institute . , Marian...keland University Hospital, in Bergen, Norway, and...
(Date:11/25/2009)...Does stress increase blood pressure? This simple ...r many years. New Stress-related gene Modulates H...rease blood pressure? This simple question has be...Now new research has for the first time establishe...blood pressure response to stress in mice as well ...
Breaking Medicine News(10 mins):Health News:Kansas City Prepares for Largest Free Health Clinic 2Health News:Sentinelle Medical Launches Aegis Suite of Oncology 4D Visualization Software with PureWeb(TM) Technology 2Health News:Sentinelle Medical Launches Aegis Suite of Oncology 4D Visualization Software with PureWeb(TM) Technology 3Health News:Black AIDS Institute Announces 2010 Board Election Results 2Health News:New stress-related gene modulates high blood pressure in mice and men 2
...NCD Celebrating 30 Years of Empowerment: 1978-2008...ional Council on Disability,s monthly bulletin for...arge and at NCD,s award-winning Web,site ( http://...ss.gpo.gov, click on "Online mailing list archive...
...Company to Help Improve Dental Health Care for Mor...ns and Alaska Natives, SAN DIEGO and MCLEAN, Va.,... Corporation (NYSE: SAI ) today announced,it has ...This single-award, prime contract has a one year b...
...HERMOSA BEACH, Calif., April 9 The Massage Spot,a...ge location in Manhattan,Beach, California, one bl...g Mecca and plans to expand the mini day spa conce...censing,opportunities. It is also preparing to org...
...Release to manufacturing of the new unified intell...s to unlock the power of all data from their ..., Wash., April 9, 2008 Microsoft Corp.,today anno... sitting in isolated clinical, financial and admin...
...RADNOR, Pa., April 8, 2008 The following statemen...rroway Topaz & Kessler, LLP:, Notice is hereby gi...nited States District Court for the Western Distri...8 and March 11,2008, inclusive (the "Class Period"...
...LOUISVILLE, Ky., April 8, 2008 Ventas, Inc.,(NYSE...ay that it will issue,its 2008 first quarter earni... May 6, 2008. A conference call to discuss those e...ccessed at,the Company,s website at http://www.ve...
Other Medicine News:Health News:National Council on Disability Monthly Bulletin for March 2008 2Health News:National Council on Disability Monthly Bulletin for March 2008 3Health News:SAIC Awarded $16 Million Contract by General Services Administration 2Health News:The Massage Spot Announces Opening of Manhattan Beach Location; Seeks Investors for Growth of 'Affordable Luxury' Mini Day Spa Concept 2Health News:The Massage Spot Announces Opening of Manhattan Beach Location; Seeks Investors for Growth of 'Affordable Luxury' Mini Day Spa Concept 3Health News:New Version of Microsoft Amalga Now Available to Hospitals and Health Systems 2Health News:New Version of Microsoft Amalga Now Available to Hospitals and Health Systems 3Health News:New Version of Microsoft Amalga Now Available to Hospitals and Health Systems 4Health News:Shareholder Class Action Filed Against Humana Inc. by The Law Firm of Schiffrin Barroway Topaz & Kessler, LLP 2Health News:Shareholder Class Action Filed Against Humana Inc. by The Law Firm of Schiffrin Barroway Topaz & Kessler, LLP 3
IMMULITE/IMMULITE 1000 Cortisol
...ors from KUBTEC represents a stand-alone, high-res...to 16 bit digital interface. The large sensing are... spacing down to 48 microns. All models are availa...ed energy range (10-160 kV). Applications range fr...
...UBTEC is a dual capability system with the ability...on of the specimen under test. While the XCAT seri...X-ray images, the micro focus source also allows t...ard 2D images. The 100 mm x 100 mm digital detecto...
...men radiography. The XPERT represents a research t...n every digital x-ray image, thus being able to ca...ore were lost to the human eye. With features incl...e, multi-color digital operator interface, and a 1...
Medicine Products: