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Regulatory Affairs / Drug Approvals News

The latest Regulatory Affairs News & Drug Approvals News articles published daily. Includes news on FDA approvals, EMEA approvals and other regulatory issues. Category added August 2007.

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Regulatory Affairs / Drug Approvals News Articles Archive - Page 5

25 September 2009

pSivida Anounces New Iluvien(R) Pilot Study In Patients With Macular Edema Secondary To Retinal Vein Occlusion

24 September 2009

FDA Advisory Committee Hears Presentations And Public Comment On EXALGO Extended-Release Tablets

FDA: Institute Of Medicine To Study Premarket Clearance Process For Medical Devices

Sangamo BioSciences Announces Plans To Initiate A Second Clinical Trial Of CCR5-ZFP Therapeutic To Treat HIV/AIDS

Oxygen Biotherapeutics, Inc. Receives Phase II Trial Approval In Israel

CTI Life Sciences Ltd. Withdraws Its Marketing Authorisation Application For Opaxio (paclitaxel Poliglumex)

23 September 2009

Physio-Control Receives Market Approval From Health Canada For LIFEPAK(R) 15 Monitor/Defibrillator

FDA: Philips Lifeline Issues Safety Alert For Lifeline Pendant Personal Help Buttons

Candy And Fruit Flavored Cigarettes Now Illegal In United States; Step Is First Under New Tobacco Law

Flavored Cigarettes Aimed At Children Banned By FDA

AAPS Co-Sponsors Workshop Focusing On Modified Release Drug Products

FDA Clears Sysmex XE-2100D Hematology Analyzer For Blood Processing Center Quality Control Release Testing

MAQUET Cardiovascular Receives FDA Clearance For MEGA(TM), The World's First 8Fr. 50cc Intra-Aortic Balloon Catheter

2.25 MM CYPHER(R) Sirolimus-eluting Coronary Stent Approved By FDA

22 September 2009

MethylGene To Resume Development Of Its HDAC Inhibitor, MGCD0103 (Mocetinostat)

FDA Awards Three Grants Designed To Stimulate Development Of Pediatric Medical Devices

Leading Cardiovascular Surgeons Gather From Around The World To Share Ross Procedure Survival Data, Techniques At 2nd Annual Summit

Third Global Vaccine Congress In Singapore To Also Feature Virtual Component

Abbott Receives FDA Approval For First Fully Automated Blood Screening Test For HIV-1/HIV-2

Neuralstem Receives FDA Approval To Commence First ALS Stem Cell Trial

Boston Scientific Completes Enrollment In Pivotal Workhorse Trial For Next Generation Everolimus Stent

MedImmune Receives U.S. Government Order For Additional 29 Million Doses Of Nasal Spray Vaccine For 2009 H1N1 Influenza

FDA Grants Priority Review Status To Supplement Containing Long-Term Survival Data For VELCADE(R) (bortezomib) For Injection

BSD Medical Corporation Reports FDA Review Of BSD-2000 Hyperthermia System Continues

21 September 2009

Ipsen: AZZALURE(R) Approved In Spain For Aesthetic Use In The Treatment Of Glabellar Lines

FDA Approves Donor Screening Test For Antibodies To HIV

FDA Announces Second Annual Science Writers Symposium

19 September 2009

FDA Approves Donor Screening Test For Antibodies To HIV

Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR For Efavirenz, Lamivudine And Tenofovir Disoproxil Fumarate Tablets

18 September 2009

FDA Warns Consumers Not To Use Stolen Albuterol Sulfate Inhalation Solution And Ipratropium Bromide Inhalation Solution

Novartis Receives FDA Approval For Valturna(R), A Single-Pill Combination Of Valsartan And Aliskiren, To Treat High Blood Pressure

China Aoxing Pharmaceutical Company Receives SFDA Approval For Clinical Trial Of Abuse Resistant Opioid Drug

17 September 2009

APP Pharmaceuticals Receives Approval For Deferoxamine Mesylate For Injection, USP

FDA Approves H1N1 Vaccines, Paving Way For Large-Scale U.S. Vaccination Campaign

FDA Advisory Committee Unanimously Recommends Approval Of XIAFLEX(TM) For Treatment Of Dupuytren's Disease

Sanofi-Aventis Receives Complete Response Letter From The FDA For Eplivanserin (Ciltyri(R)) Submission

New Drug For Hand Contracture Disorder Gets FDA Panel Support

FDA Requires Boxed Warning For Promethazine Hydrochloride Injection

16 September 2009

FDA Approves Vaccines For 2009 H1N1 Influenza Virus

U.S. FDA Licenses Sanofi Pasteur's Pandemic Influenza Vaccine

Advanced Life Sciences Announces Restanza(TM) Granted FDA Orphan Drug Designation For Plague And Tularemia

Merz Pharmaceuticals' Belotero(R) Balance PMA Filing Formally Accepted For Review By The FDA

BioVex Agrees SPA With The FDA For A Pivotal Phase III Study With OncoVEX (GM-CSF) In Head And Neck Cancer

European Union Commission Approves Expanded Use Of ISENTRESS(R) (raltegravir), From MSD, In Adult Patients With HIV-1 Infection

15 September 2009

St. Jude Medical Announces FDA Approval Of EnSite Velocity Cardiac Mapping System

Abbott Announces Approval In China For Next-Generation XIENCE V(R) Drug Eluting Stent

Pivotal Data Demonstrating Efficacy Of Darusentan In Treating Resistant Hypertension Published In The Lancet

FDA And EMEA Grant Orphan Drug Designation For Antisense Pharma's Investigational Drug Trabedersen In Pancreatic Carcinoma

14 September 2009

FDA Consumer Health Information Updates

Theravance And Astellas Announce FDA Approval Of VIBATIVTM (telavancin) For The Treatment Of Complicated Skin And Skin Structure Infections

12 September 2009

New Data Show Patients With Chronic Low Back Pain Maintained Pain Reduction On Cymbalta(R)

U.S. Food And Drug Administration Clears Vermillion's OVA1(TM) Test To Determine Likelihood Of Ovarian Cancer In Women With Pelvic Mass

FDA Clears A Test For Ovarian Cancer

Radioimmunotherapy Drug Cleared As First-Line Treatment For Non-Hodgkin's Lymphoma

11 September 2009

FDA Panel Recommends Approval Of HPV Vaccine Cervarix For Women, Gardasil For Male Warts

FDA Updates "Warning Letters" Web Page

FDA Issues Complete Response Letter For Trabectedin Combined With DOXIL

Centocor Ortho Biotech Receives FDA Complete Response Letter Regarding DOXIL(R) For The Treatment Of Advanced Breast Cancer

10 September 2009

FDA Advisory Committee Recommends Approval For Use Of GARDASIL(R) In Boys And Men

NICE Proposes To Refuse Nexavar(R) (Sorafenib) For Liver Cancer Patients

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FDA Approves H1N1 Vaccines, Paving Way For Large-Scale U.S. Vaccination Campaign
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Ed is taking the conservative approach to treating his lower back pain. His physiatrist, Dr. Neal Mesnick, says strengthening the core muscles that support the spine is the key to success. He also says surgery should only be a last resort.

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