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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St. Jude Medical Announces FDA Clearance And CE Mark Approval Of Strada Carotid Guiding Sheath

09 May 2008

St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Strada™ Carotid Guiding Sheath, a flexible tube through which physicians can deliver...
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Osteologix IND For NB S101 For Osteoporosis Accepted By FDA

09 May 2008

Osteologix, Inc. (OLGX.OB), a specialty biopharmaceutical company, announced that the U. S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead development candidate NB...
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Boston Scientific Announces FDA Approval Of New Family Of Advanced Pacemakers

09 May 2008

Boston Scientific Corporation (NYSE: BSX) announced U.S. Food and Drug Administration (FDA) approval of its ALTRUA(TM) family of pacemakers. ALTRUA is Boston Scientific's most advanced pacemaker and delivers enhanced...
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Regulatory Affairs / Drug Approvals News Articles Archive - Page 1

08 May 2008

Survival Of Extremely Premature Babies Is Not Improving With Modern Medicine

Shire Investigational Nonstimulant INTUNIV Showed Significant Efficacy In Reducing ADHD Symptoms

Lev Pharmaceuticals Announces Cinryze(TM) Complete Response Submission Accepted For Review By FDA

National Community Pharmacists Association Statement On "Sense Of Congress" Resolution Opposing FDA Restrictions On Estriol Usage

Dutch Authorize Manufacture Of Vaccinogen's New Anti-Colon Cancer Vaccine; License Clears Path To European Production, Final FDA Trial

Cynosure's Accolade(TM) Workstation For Pigmented Lesions Receives Korean Regulatory Approval

07 May 2008

Pharmacogenetic Findings May Lead To Individualized Treatment For Schizophrenia

Advantage Medical Devices Receives FDA Clearance For VantageCath(TM)

Gore Receives Approval From FDA For Unique Patent Foramen Ovale Stroke Study

ParagonDx Receives FDA 510(k) Marketing Clearance For Warfarin Sensitivity Genotyping Kit

Vascular Insights Receives FDA Clearance For Infusion Catheter

06 May 2008

Gout - Adenuric(R) (Febuxostat) Receives Marketing Authorisation In The European Union

Albemarle Optimizes Smallpox Drug Candidate For SIGA

New Study Confirms Dose Accuracy Of SoloSTAR(R) Prefilled Insulin Pen

05 May 2008

FDA Official Pulls Back On Estimates Of Cost To Inspect Foreign Drug Makers Properly

FDA Sends Warning Letter To Merck About Manufacturing Problems At Pa. Plant

HeartMate II Mechanical Heart Pump For Heart-Failure Patients Approved By FDA

AngioScore Receives FDA Clearance To Market AngioSculpt PTA Scoring Balloon Catheter For Additional Peripheral Indications

NICE And Its Decision Not To Approve Rheumatoid Arthritis Drug Abatacept, UK

04 May 2008

European Commission Grants Full Approval Of HIV Protease Inhibitor, Tipranavir (Aptivus®)

FDA Approves Advair 250/50 For Reduction Of Exacerbations In Patients With COPD

GlaxoSmithKline's Volibris (ambrisentan) Receives Authorisation From The European Commission For The Treatment Of Functional Class Hypertension

GSK Receives Positive Opinion For Conditional Approval Of New Oral Breast Cancer Treatment, Tyverb (lapatinib)

02 May 2008

FDA Completes Final Analysis Of "Total Body Formula" And "Total Body Mega Formula" Products

Renewed Hope For Mild Alzheimer's Patients As NICE Process On Anti-Dementia Medicines Ruled Unfair, UK

01 May 2008

British Cosmetics Doctors Unite Against Laser De-Regulation

Inhibitex Initiates Phase I Trial Of FV-100 For The Treatment Of Shingles

FDA Approves Advair(R) 250/50 For Reduction Of Exacerbations In Patients With COPD

FDA Approves MIXJECT(TM), A Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceutical's TRELSTAR(R) DEPOT And TRELSTAR(R) LA

30 April 2008

Sucampo Pharmaceuticals Obtains FDA Approval For AMITIZA(R) For The Treatment Of Irritable Bowel Syndrome With Constipation In Adult Women

Metal Packaging Industry Welcomes FDA Statement On Bisphenol A (BPA)

Relief For Cancer Patients Suffering From Opioid-Induced Bowel Disorders

Medtronic Receives Approval To Market Smaller Kit Sizes Of Infuse(R) Bone Graft

Heparin Testimonies Before House Committee

Coronary Artery Plaque Imaging Device Cleared By FDA

FDA Approves Amitiza For IBS-C - Only Drug Available In USA For Irritable Bowel Syndrome With Constipation

Kohl, Durbin Investigate AMA Program Allowing Doctors To Opt-Out Of Having Prescribing Data Sold To Drug Companies, USA

Merck Receives Not Approvable Letter From FDA For MK-0524A (ER Niacin/laropiprant)

Acusphere Submits New Drug Application For FDA Approval Of Imagify(TM)

Teva Announces Approval Of Generic Flolan(R) For Injection

Third Wave Completes FDA Submissions For Its Two HPV Products

29 April 2008

Statement, Scientific Protein Laboratories - Subcommittee On Oversight & Investigations Committee On Energy & Commerce US House Of Representatives

Testimony Of Baxter Int. CEO Before Subcommittee On Oversight And Investigations Committee On Energy And Commerce U.S. House Of Representatives

CQ's Carey Looks At Genetic Anti-Discrimination Measure, Legislation To Block Medicaid Rules Implementation, FDA Hearings

Rheumatoid Arthritis Patients Not To Have Access To Treatment If First One Is Unsuitable, England

Medtronic Announces FDA Clearance Of New OneTouch(R) Ultralink(TM) Blood Glucose Meter

Physio-Control And FDA Agree On Plan To Address Quality System Issues

Animal Models Not Suitable For Spinal Cord Injury Research

What The Public Needs To Know About Restaurant Inspections

MediQuest Therapeutics Submits Drug Application To FDA To Treat Raynaud's Disease

Viscosity Enhancers That Thicken Blood Are Highly Effective In Treating Severe Hemorrhage

Purdue Expert Says U.S. Has Low Risk Of Receiving Contaminated Drugs

EU Approval For Zevalin(R) As First-Line Consolidation Treatment

Tracleer (Bosentan) Receives New Indication In Patients With Systemic Sclerosis And Active Digital Ulcer Disease

Endogun Medical Systems Ltd. Receives FDA Approval For Next-Generation Soft Tissue Attachment Device

28 April 2008

FDA Official Says Agency Cannot Ensure Safety Of All Medications Sold In U.S.

Glaxosmithkline's Volibris Receives Authorisation From The European Commission For The Treatment Of Functional Class II And III PAH

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