Regulatory Affairs News & Drug Approvals News from Medical News Today

Regulatory Affairs / Drug Approvals News

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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 8

18 August 2009

EndyMed Medical Receives FDA Clearance For Painless, Non-invasive Anti-Wrinkle Treatment System

U.S. Marshals Seize Skin Sanitizer, Protectant Products Made By Clarcon Biological Chemical Laboratory Inc.

FDA, European Medicines Agency Launch Good Clinical Practices Initiative

FDA Gives Update On Botulinum Toxin Safety Warnings; Established Names Of Drugs Changed

FDA Approves New Cholesterol-Lowering Drug

17 August 2009

Mesoblast Limited (ASX:MSB) Gains US FDA Clearance For Phase 2 Trial Of NeoFuse In Minimally Invasive Lumbar Spinal Fusion Surgery

Comment From ASCO President Douglas W. Blayney, MD, On The FDA's Rule To Expand Patient Access To Investigational Drugs

Reverse Medical Corporation Receives US FDA 510k Clearance For The ReCruitTM Microcatheter For Use Including Neuro Interventional Procedures

16 August 2009

FDA Approves Saphris Tablets (asenapine) To Treat Schizophrenia And Bipolar Disorder

FDA Issues Final Rules To Help Patients Gain Access To Investigational Drugs

15 August 2009

Schering-Plough Announces FDA Approval Of SAPHRIS(R) (asenapine) For Acute Treatment Of Schizophrenia In Adults And Manic Or Mixed Episodes Of Bipolar

FDA Approves EMBEDA(TM) For Management Of Moderate To Severe Chronic Pain

Bayer's CONTOUR And Bayer's BREEZE2 Blood Glucose Monitoring Systems Do Not Use Problematic GDH-PQQ Technology

14 August 2009

FDA Regulations To Improve Access To Investigational Drugs For People With HIV/AIDS, Other Illnesses

Recommndation By Stanford Researchers That Drug Labels Should Disclose Lack Of Comparison With Existing Medications

13 August 2009

Essentialis To Submit SPA For Hypertriglyceridemia

CryoLife Receives FDA 510(k) Clearance For SynerGraft(R) Processed Human Cardiac Patch Material

Nfocus Neuromedical Obtains CE Approval For New Vascular Reconstruction Device

Positive Phase III Study Results For Zenvia Announced By AVANIR

12 August 2009

Breakthrough Drug-Eluting Stent To Treat Peripheral Artery Disease Gains CE Mark

BrainScope(TM) Receives FDA Clearance For Portable EEG Device

ProUroCare Medical Completes Clinical Trial At Second Study Site Using Digital Prostate Imaging Technology

11 August 2009

Ventavis (Iloprost) In Pulmonary Arterial Hypertension Receives US Approval For Increased 20 Mcg/ml Strength Formulation

Tracleer Receives Label Extension In US For The Treatment Of Patients With Mildly Symptomatic WHO Functional Class II Pulmonary Arterial Hypertension

Vion Pharmaceuticals Announces Oncologic Drugs Advisory Committee Meeting For Onrigin(TM)

Mylan Receives FDA Approval For Generic Version Of Migraine Treatment Imitrex(R)

09 August 2009

European Commission And U.S. FDA Grant Alexion's Soliris® Orphan Drug Designation For The Treatment Of Atypical Hemolytic Uremic Syndrome (aHUS)

Tuna Salad Sandwiches, Other Products Seized At Louisiana Company By FDA

FDA Steps Up Efforts To Prevent Non-compliant Investigators And Others From Participating In New Product Development

FDA Issues Pharmaceutical Industry Guidance On Preventing Melamine Contamination

08 August 2009

Sanofi Pasteur Submits Supplemental Application For A(H1N1) Pandemic Vaccine To U.S. FDA

FDA Approves New 3000 IU Vial Size For Kogenate(R) FS, Antihemophilic Factor (recombinant)

Clearance Received By Covidien For Its Puritan Bennett 840 Ventilator System

07 August 2009

Vectibix(R) In Combination With Chemotherapy Significantly Improved Progression-Free Survival In First-Line Metastatic Colorectal Cancer

Amgen And Wyeth Statement On FDA Announcement About Tumor Necrosis Factor (TNF) Blockers

FDA Approves Avastin For The Most Common Type Of Kidney Cancer

Watson Pharmaceuticals Receives FDA Approval For Generic Toprol XL(R) 25 MG And 50 MG

New Therapeutic Option For Heartburn

Afinitor® Approved In EU As First Treatment Proven To Benefit Patients With Advanced Kidney Cancer After Failure Of Targeted Therapy

06 August 2009

Aradigm Receives Orphan Drug Designation For Inhaled Liposomal Ciprofloxacin To Treat Cystic Fibrosis In Europe

Government Moves To Regulate Practitioners Of Herbal/Traditional Medicine, UK

Covidien Receives FDA Clearance For Its Puritan Bennett 840™ Ventilator System With New Automatic Leak Adjustments Software Option

NeurogesX Announces New PDUFA Date For Qutenza(TM) New Drug Application

State Regulation Of Massage Therapy Will Improve Public Health, Safety

05 August 2009

Ferring Pharmaceuticals Announces Trade Name Firmagon (Degarelix ForInjection) For Advanced Prostate Cancer Treatment

AccuVein Vein Illuminator Receives European CE Mark

Dietary Supplements With Steroids Pose Health Danger: Case Studies

ARUP Laboratories Applauds FDA's Decision On The Value Of KRAS-Mutation Testing In Colorectal Cancer

Ferring Pharmaceuticals Announces Trade Name FIRMAGON(R) (degarelix For Injection) For Advanced Prostate Cancer Treatment

Palatin Technologies, Inc. Receives U.S. Patent Allowance For Heart Failure Drug Candidate

DOR BioPharma Receives FDA Orphan Drug Designation For OrBec(R) For The Treatment Of Chronic Gastrointestinal GVHD

FDA Approves LIVALO(R) For Primary Hypercholesterolemia And Combined Dyslipidemia

Nephrologists Indicate High Interest In AMAG Pharmaceuticals' Newly Approved Feraheme According To Latest BioTrends Report

PEAK Surgical Introduces PEAK PlasmaBlade(TM) TnA

04 August 2009

Should Practitioners Of Acupuncture, Herbal Medicine And Traditional Chinese Medicine Be Regulated? UK

FDA Approves INVEGA(R) SUSTENNA(TM) For The Acute And Maintenance Treatment Of Schizophrenia

Savient Pharmaceuticals Receives Complete Response Letter From U.S. Food And Drug Administration For KRYSTEXXA(TM)

Micromet Receives European Orphan Drug Designation For Treatment Of Acute Lymphoblastic Leukemia With BiTE Antibody Blinatumomab

03 August 2009

U.S. Food And Drug Administration Approves ONGLYZA™ (saxagliptin) For The Treatment Of Type 2 Diabetes Mellitus In Adults

New Survey Shows Americans Spend $34 Billion On Alternative Treatments

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