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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 18 Jul 2007
FDA Classifies Baxter's Field Corrective Action as a Class I Recall on Recently Manufactured or Upgraded Colleague Triple Channel Infusion Pumps (Models 2M8153, 2M8163 and 2M9163)
Devices Product Recall
 HSMN NewsFeed - 18 Jul 2007
FDA Grants Fast Track Designation to Cardium's Phase 3 Angiogenic Gene Therapy for Heart Disease
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 18 Jul 2007
Advanced Medical Optics Receives FDA Approval for Advanced CustomVue(TM) Monovision Procedure for the Treatment of Presbyopic Myopes
Devices Ophthalmology FDA
 HSMN NewsFeed - 17 Jul 2007
Medtronic Receives FDA Panel's Recommendation for Approval of the Bryan(R) Cervical Disc
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 17 Jul 2007
ABILIFY(R) (aripiprazole) Supplemental New Drug Application Receives Priority Review by U.S. Food And Drug Administration for Adjunctive Treatment in Adults With Major Depressive Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jul 2007
Neurochem receives approvable letter for eprodisate (KIACTA(TM)) for treatment of AA amyloidosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jul 2007
Lupin Receives Final Approval for Amlodipine Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 17 Jul 2007
Escalon(R) Receives 510(k) Clearance from FDA for Distribution of TRILOGY(R) Analyzer
Diagnostics FDA
 HSMN NewsFeed - 17 Jul 2007
Cortex to Resume Clinical Trial with AMPAKINE(R) CX717 in Alzheimer-PET Scan Study after FDA Approves Protocol with Higher Doses of Drug
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 17 Jul 2007
FDA Approves Extina(R) for the Treatment of Seborrheic Dermatitis
Biopharmaceuticals Dermatology Drug Delivery FDA
 HSMN NewsFeed - 17 Jul 2007
Aventir Biotech Launches New 510(k) Cleared Fecal Occult Blood Screen Test
Diagnostics FDA
 HSMN NewsFeed - 17 Jul 2007
Medtronic Receives Approval for First Artificial Disc for the Neck in the United States
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 16 Jul 2007
FDA Approves Demipulse and Demipulse Duo Generators
Devices Neurology FDA
 HSMN NewsFeed - 13 Jul 2007
Gore REVISE Study Receives Conditional Approval from FDA
Devices Interventional FDA
 HSMN NewsFeed - 12 Jul 2007
Exactech Announces FDA Approval for Novation Ceramic Articulation Hip System, Adjusts 2007 Financial Targets
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Jul 2007
FDA Grants CLIA Waived Status to Cholestech for New Combined Test Panel
Diagnostics FDA
 HSMN NewsFeed - 12 Jul 2007
Integra LifeSciences Announces Launch of the Uni-CP Compression Plate
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Jul 2007
Abbott Announces Approval of First Fully-Automated Blood Screening Test for Hepatitis C Antibodies
Diagnostics FDA
 HSMN NewsFeed - 12 Jul 2007
Collegium Pharmaceutical Inc. Announces FDA Acceptance of IND for its Abuse Deterrent Sustained Release Opioid Product
Biopharmaceuticals Pain Management FDA
 HSMN NewsFeed - 12 Jul 2007
Spectranetics Receives FDA Clearance for Expanded Labeling for TURBO Elite
Devices Interventional FDA
 HSMN NewsFeed - 12 Jul 2007
Sciton Receives FDA Clearance for Laser-Assisted Lipolysis and Pulsed Light Wrinkle Treatment
Devices Dermatology FDA
 HSMN NewsFeed - 10 Jul 2007
bioLytical Receives FDA Clearance to Initiate Clinical Trial for 60-Second HIV Test
Diagnostics HIV/AIDS FDA
 HSMN NewsFeed - 10 Jul 2007
Ranbaxy Receives Final Approval To Manufacture and Market Amlodipine Besylate Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Jul 2007
CardioVascular BioTherapeutics Authorized to Initiate Phase II Trial of Angiogenesis Therapy for Severe Coronary Heart Disease
Biopharmaceuticals Devices Drug Delivery Cardiology FDA
 HSMN NewsFeed - 10 Jul 2007
Aragon Surgical LapCap Receives FDA 510(k) Clearance With Expanded Indications for Use
Devices Surgery FDA
 HSMN NewsFeed - 9 Jul 2007
Corcept Therapeutics Receives Orphan Drug Designation for CORLUX(R) Treatment of Cushing's Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Jul 2007
AtriCure's Isolator(R) Bipolar Ablation Clamp System Receives FDA 510(k) Clearance for Cardiac Use
Devices Cardiology FDA
 HSMN NewsFeed - 9 Jul 2007
FDA Clears Small Bone Innovations' Implant to Treat Thumb Arthritis
Devices FDA Orthopaedic
 HSMN NewsFeed - 9 Jul 2007
Barr Announces Approval of Generic Dostinex(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 6 Jul 2007
OMRIX Biopharmaceuticals Receives Food and Drug Administration (FDA) Approval to Use Cryoprecipitate from Talecris Biotherapeutics, Inc. in Its Manufacturing Process
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Jul 2007
FDA Approval Allows Stryker to Market Hip Resurfacing System In Third Quarter of 2007
Devices Orthopaedic FDA
 HSMN NewsFeed - 3 Jul 2007
Vascular Solutions Announces 510K Clearance and First Clinical Uses of Gopher Catheter
Devices FDA Interventional
 HSMN NewsFeed - 2 Jul 2007
Tamiflu(R) 30 mg and 45 mg Capsules Approved by U.S. Food and Drug Administration
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Jul 2007
Reliant Technologies Receives FDA Clearance for Fraxel re:pair(TM) Laser System
Devices Dermatology FDA
 HSMN NewsFeed - 2 Jul 2007
Spectranetics Receives FDA Clearance to Market TURBO-Booster
Devices FDA
 HSMN NewsFeed - 29 Jun 2007
Teva Announces Approval of Amlodipine Besylate Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 29 Jun 2007
Akorn, Inc. Announces the New Drug Application (NDA) Filing for Akten(R)
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 29 Jun 2007
Labopharm meets with FDA to discuss second Approvable Letter for once-daily tramadol
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Jun 2007
St. Jude Medical Announces FDA and CE Mark Approvals Of QuickOpt Timing Cycle Optimization For Additional Heart Failure Devices
Devices Cardiology FDA
 HSMN NewsFeed - 28 Jun 2007
Cephalon Announces Plans for New NDA Filing for TREANDA(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 28 Jun 2007
Cerner Receives FDA Clearance for Cerner Bridge Transfusion Administration and Specimen Collections
Devices FDA
 HSMN NewsFeed - 28 Jun 2007
Inverness Medical Innovations Announces FDA Clearance of the BinaxNOW(R) Malaria Antigen Detection Rapid Test
Diagnostics FDA
 HSMN NewsFeed - 28 Jun 2007
Teva Announces Tentative Approval of Famciclovir Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 27 Jun 2007
FDA Advisory Panel Recommends Approval of CryoCor's PMA
Devices Cardiology
 HSMN NewsFeed - 27 Jun 2007
Alseres Pharmaceuticals Announces FDA Clearance to Increase Dose Level in Cethrin(R) Phase I/IIa Clinical Trial for Acute Spinal Cord Injury at U.S. Sites
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 27 Jun 2007
Aspect Medical Systems Receives FDA Clearance for BIS View(TM) Monitoring System
Devices Monitoring FDA
 HSMN NewsFeed - 27 Jun 2007
FDA Grants Fast Track Status for HCV-796 for Treatment of Hepatitis C Virus Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Jun 2007
Taxotere(R) (docetaxel) Granted FDA Priority Review for Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and Neck Prior to Chemoradiotherapy and Surgery
Biopharmaceuticals FDA Oncology
 HSMN NewsFeed - 27 Jun 2007
FDA Priority Review Granted for ISENTRESS(TM) (raltegravir), Merck's Investigational Integrase Inhibitor for HIV
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 27 Jun 2007
YM BioSciences Receives FDA Clearance for an IND for its Fentanyl-Based Pain Product AeroLEF(TM)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 27 Jun 2007
Vasogen Reports on Outcome of FDA Meeting
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 26 Jun 2007
Advancis Pharmaceutical Reports on Meeting with FDA Reviewing Keflex PULSYS Phase III Trial Design
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 26 Jun 2007
Teva Announces Approval of Ondansetron HCl Tablets and Ondansetron Orally Disintegrating Tablets USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Jun 2007
Barr Announces Tentative Approval for a Generic Version of Effexor(R) Tablets, 25mg, 37.5mg, 50mg, 75mg and 100mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 26 Jun 2007
Allergan Announces FDA Approval of Label Extensions for JUVEDERM(TM) Ultra and JUVEDERM(TM) Ultra Plus
Devices Dermatology FDA
 HSMN NewsFeed - 26 Jun 2007
SunTech Medical Receives FDA Clearance for the SunTech 247(TM) Diagnostic Station
Devices Monitoring FDA
 HSMN NewsFeed - 26 Jun 2007
KV Pharmaceutical Company Receives ANDA Approval for 4 mg. and 8 mg. Ondansetron Orally Disintegrating Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 25 Jun 2007
Mylan Announces Final FDA Approval for Ondansetron Hydrochloride Tablets and Ondansetron Orally Disintegrating Tablets, USP
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 25 Jun 2007
Genzyme Receives FDA Approval for New Labeling for Carticel(R)
Biopharmaceuticals Devices Orthopaedic FDA
 HSMN NewsFeed - 25 Jun 2007
Life Spine Announces FDA Approval of Neo(R)-SL
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 22 Jun 2007
FDA Approves Carnitor(R) SF (Levocarnitine) Sugar-Free Oral Solution For Patients With Carnitine Deficiency
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jun 2007
Ranbaxy Receives Tentative Approval for Tamsulosin Capsules
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 22 Jun 2007
Barr Receives Approval for Generic VESANOID(R) Capsules, 10 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 22 Jun 2007
FDA Approves Novartis Consumer Health, Inc.'s Over-the-Counter THRIVE(TM) Gum for Cessation of Smoking
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2007
FDA Approves Ferring Pharmaceuticals' ENDOMETRIN(R) for Luteal Phase Support in Assisted Reproductive Technology Treatment
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2007
Pfizer's Lyrica Receives FDA Approval for Fibromyalgia Based on Expedited Review
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2007
FDA Issues Approvable Letter for RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2007
VIVUS Completes End of Phase 2 Meeting with the FDA for Qnexa, a Treatment for Obesity
Biopharmaceuticals
 HSMN NewsFeed - 21 Jun 2007
King Pharmaceuticals Announces FDA Approval of Epistaxis Kit for THROMBIN-JMI(R)
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2007
Arpida Receives Approval From US FDA to Initiate a Phase II Trial With iclaprim in Hospital-Acquired, Ventilator and Healthcare-Associated Pneumonia
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2007
Shire Receives Approvable Letter From FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2007
Exforge(R) Receives Final US Approval as New and Powerful Treatment Option for Patients With High Blood Pressure
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jun 2007
Pfizer Receives Approvable Letter From FDA For Maraviroc
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 20 Jun 2007
Merck Provides Update on Status of Supplemental Biologics License Applications (sBLA) for GARDASIL(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 20 Jun 2007
Genzyme Files for Approval of Single-Treatment Synvisc-One(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jun 2007
Ranbaxy Receives Tentative Approval to Manufacture and Market Amlodipine Besylate Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 20 Jun 2007
FDA Approves Differin(R) (adapalene) Gel, 0.3% for Acne
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 19 Jun 2007
Small Bone Innovations Adds Artelon(R) CMC Spacer Arthro to Thumb Osteo- Arthritis Implant Line
Devices Orthopaedic FDA
 HSMN NewsFeed - 19 Jun 2007
Immucor's Echo Cleared by FDA for Marketing in U.S.
Diagnostics FDA
 HSMN NewsFeed - 19 Jun 2007
CryoCor Confirms FDA Advisory Panel Meeting
Devices Cardiology FDA
 HSMN NewsFeed - 19 Jun 2007
Smiths Medical Receives FDA Clearance for Power Injectable Ports and Safety Needles
Devices FDA
 HSMN NewsFeed - 19 Jun 2007
Novalar Announces Acceptance of NV-101 New Drug Application for Filing by FDA
Biopharmaceuticals Dental FDA
 HSMN NewsFeed - 19 Jun 2007
FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 18 Jun 2007
NeuroVasx, Inc. Announces 510(k) FDA Submission of its cPAX Aneurysm Treatment System(TM) for Treatment of Cerebral Aneurysms
Devices Interventional Neurology
 HSMN NewsFeed - 18 Jun 2007
Medtronic Receives FDA Approval for New Tripolar, 16-Electrode Neurostimulation Lead to Treat Chronic Pain
Devices FDA
 HSMN NewsFeed - 18 Jun 2007
CoMentis Receives FDA Clearance to Begin Human Clinical Trials for Its Disease-Modifying Alzheimer's Therapy
Biopharmaceuticals Neurology
 HSMN NewsFeed - 18 Jun 2007
Salix Pharmaceuticals Announces Positive Top Line Results of Balsalazide Tablets Registration Study
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 18 Jun 2007
Cephalon Receives FDA Approval of NUVIGIL(TM) for the Treatment of Excessive Sleepiness Associated with Three Disorders
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jun 2007
FDA Converts TELCYTA Full Clinical Hold to Partial Hold
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Jun 2007
FDA Issues Third Approvable Letter for Thelin (Sitaxsentan Sodium)
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jun 2007
U.S. Food and Drug Administration Approves Gilead's Letairis(TM) (ambrisentan) 5 mg and 10 mg Tablets for the Once-Daily Treatment of Pulmonary Arterial Hypertension (WHO Group 1) in Patients with WHO Functional Class II or III Symptoms
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jun 2007
Collegium Pharmaceutical Inc., Announces the Filing of IND for Abuse Deterrent Sustained Release Opioid Product
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 15 Jun 2007
FDA Approves New Route of Administration for Rapid-Acting Apidra(R) Providing an Additional Treatment Option for Hospitalized Diabetes Patients with High Blood Sugar Levels
Biopharmaceuticals Endocrinology
 HSMN NewsFeed - 14 Jun 2007
Mindray Receives FDA Approval for Two Products Targeting North American Market
Diagnostics FDA
 HSMN NewsFeed - 14 Jun 2007
Given Imaging Receives U.S. Marketing Clearance for PillCam(R) ESO 2
Devices Gastroenterology FDA
 HSMN NewsFeed - 13 Jun 2007
FDA Advisory Committee Did Not Recommend Approval of Rimonabant (ZIMULTI(R)) for Use in Obese and Overweight Patients With Associated Risks Factors
Biopharmaceuticals FDA Endocrinology
 HSMN NewsFeed - 13 Jun 2007
FDA Clearance for World's First RFID Surgical Sponge Counting System to Prevent Retention of Surgical Sponges
Devices Surgery
 HSMN NewsFeed - 13 Jun 2007
LifeCell Corporation Receives 510(k) Clearance for Tissue Repair Product
Devices FDA
 HSMN NewsFeed - 12 Jun 2007
CEL-SCI Receives US FDA Orphan Drug Designation for Its Cancer Drug Multikine(R)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Jun 2007
Xanthus Completes Special Protocol Assessment with FDA for Phase 3 Registration Trial of Xanafide in Patients with Secondary Acute Myeloid Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 12 Jun 2007
Eurand Files NDA for Zentase(TM) for Exocrine Pancreatic Insufficiency
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Jun 2007
FDA Grants Ceragenix's Request for Designation
Devices Biopharmaceuticals Wound Care FDA
 HSMN NewsFeed - 12 Jun 2007
LinkMed: SACS Medical is Granted FDA Clearance
Devices Monitoring FDA
 HSMN NewsFeed - 11 Jun 2007
KCI Announces U.S. Food and Drug Administration Clearance for Next-Generation V.A.C.(R) Therapy Technologies Across Multiple Care Settings Including Home Use
Devices Wound Care FDA
 HSMN NewsFeed - 11 Jun 2007
Response Biomedical Files for US FDA 510(k) Market Clearance of Rapid Influenza A+B Test
Diagnostics FDA
 HSMN NewsFeed - 11 Jun 2007
Gore AVIATOR Study Receives Conditional Approval from FDA
Devices Interventional FDA
 HSMN NewsFeed - 11 Jun 2007
FDA Accepts and Grants Priority Review of ERBITUX(R) (Cetuximab) sBLA for Overall Survival in Patients with Advanced Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Jun 2007
Mylan Announces Final FDA Approval for Doxycycline Tablets, 150mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 8 Jun 2007
Regeneron Submits Biologics License Application to U.S. FDA for IL-1 Trap (Rilonacept) for Treatment of CAPS
Biopharmaceuticals
 HSMN NewsFeed - 7 Jun 2007
SpineVision(R) Reports U.S. Market Penetration Milestone: 250th Spine Surgeon Has Been Trained to Use the Company's FDA-cleared PediGuard(TM) Device
Devices Orthopaedic Neurosurgery
 HSMN NewsFeed - 7 Jun 2007
INNOVIVE Pharmaceuticals Receives FDA Fast Track Designation for Tamibarotene for the Treatment of Acute Promyelocytic Leukemia
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Jun 2007
Aspreva announces Fast-Track designation granted by the FDA for CellCept in lupus nephritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Jun 2007
Takeda Revises ACTOS(R) (pioglitazone HCl) Prescribing Label
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 6 Jun 2007
PreMD Submits 510(k) to the FDA for Expanded Regulatory Claim for PREVU(x) POC
Diagnostics FDA
 HSMN NewsFeed - 6 Jun 2007
COPAXONE(R) Pre-Filled Syringe Can Now Be Stored for up to One Month at Room Temperature
Biopharmaceuticals FDA Neurology
 HSMN NewsFeed - 5 Jun 2007
Misonix Announces FDA Clinical Trial Enrollment Acceleration for Sonablate 500 HIFU Treatment of Prostate Cancer
Devices Oncology
 HSMN NewsFeed - 5 Jun 2007
Vertebration's XYcor(TM) Spinal Implant Receives FDA 510(k) Clearance
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 5 Jun 2007
Barr Announces Tentative Approval for a Generic Version of Risperdal(R) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 5 Jun 2007
FDA Approves Divigel(R) (estradiol gel) 0.1 Percent for Treatment of Moderate to Severe Hot Flashes Associated with Menopause
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 5 Jun 2007
Swissray International, Inc. Announces FDA 510(k) Clearance to Market the ddRCompact Series
Devices Radiology FDA
 HSMN NewsFeed - 5 Jun 2007
Biovest to File for Accelerated Conditional Approval of BiovaxID
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Jun 2007
Corgenix AspirinWorks(R) Test Kit Cleared by FDA
Diagnostics Cardiology FDA
 HSMN NewsFeed - 4 Jun 2007
ev3 Receives Conditional IDE Approval to Study Use of Protege(R) EverFlex(TM) Self-Expanding Stent System in the Treatment of Peripheral Artery Disease
Devices Interventional FDA
 HSMN NewsFeed - 1 Jun 2007
Abbott Submits XIENCE(TM) V Everolimus Eluting Coronary Stent System Application for U.S. FDA Approval
Devices Interventional Cardiology
 HSMN NewsFeed - 1 Jun 2007
FDA Approves Norditropin(R)for Treatment of Short Stature Associated with a Rare Genetic Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 May 2007
Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 31 May 2007
DexCom(TM) Receives FDA Approval for Its 7-Day STS(R) Continuous Glucose Monitoring System
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 31 May 2007
OXiGENE Reaches Agreement with FDA on Special Protocol Assessment for ZYBRESTAT(TM) (CA4P) Phase II/III Pivotal Trial in Anaplastic Thyroid Cancer
Biopharmaceuticals Oncology
 HSMN NewsFeed - 31 May 2007
AcroMetrix Receives 510(k) Clearance for VeriSure(R) Pro HBV Blood Screening Controls
Diagnostics FDA
 HSMN NewsFeed - 31 May 2007
Progenics and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 31 May 2007
Dendreon Announces FDA Confirms Data Required for Provenge(R) Licensure
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 May 2007
AVANIR Receives FDA Approval for New Formulation of Currently Marketed Antipsychotic Drug FazaClo
Biopharmaceuticals FDA
 HSMN NewsFeed - 31 May 2007
Mylan Announces Final FDA Approval for Azithromycin Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 31 May 2007
Mylan Announces Tentative FDA Approval for Paroxetine Hydrochloride Extended-Release Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 31 May 2007
FDA Approves Critical Therapeutics' Twice-Daily ZYFLO CR(TM) (Zileuton) Extended-Release Tablets for Asthma
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 May 2007
FDA Approves TORISEL, a Targeted First-in-Class mTOR Inhibitor for the Treatment of Advanced Kidney Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 May 2007
Perrigo Receives FDA Approval to Market Coated Fruit Nicotine Gum
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 30 May 2007
Derma Sciences Receives FDA Clearance for MOBILITY-1(TM) Treatment of Vascular Diseases
Devices Wound Care FDA
 HSMN NewsFeed - 30 May 2007
Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec(R)
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 30 May 2007
Mylan Announces Final FDA Approval for Fluoxetine Capsules USP, 40 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 29 May 2007
Rexahn Pharmaceuticals Receives FDA Approval to Initiate a Phase II Trial for Archexin in Patients with Renal Cell Carcinoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 29 May 2007
FDA Approves XYZAL(R) (Levocetirizine Dihydrochloride) Tablets for the Relief of Seasonal and Year Round Allergies, and Chronic Hives
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 May 2007
IMPAX Receives Final FDA Approval for Generic Xanax(R) XR Extended Release Tablets
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 29 May 2007
Micrus Endovascular Receives FDA Clearance for the ENZO Steerable Microcatheter
Devices Neurology Interventional FDA
 HSMN NewsFeed - 29 May 2007
Elan and Biogen Idec Announce a FDA Advisory Committee Meeting to Review TYSABRI(R) for the Treatment of Crohn's Disease
Biopharmacetuicals Gastroenterology FDA
 HSMN NewsFeed - 25 May 2007
Novagali Pharma Receives US FDA Orphan Drug Designation for Vekacia(R) for the Treatment of Vernal Keratoconjunctivitis
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 24 May 2007
ZOLL Receives Clearance to Market E Series with See-Thru CPR Technology
Devices Cardiology FDA
 HSMN NewsFeed - 24 May 2007
FDA Approves Gen-Probe's Automated PROCLEIX(R) TIGRIS(R) System to Test Donated Blood With the PROCLEIX ULTRIO(R) Assay
Diagnostics FDA
 HSMN NewsFeed - 24 May 2007
GE Healthcare Receives FDA Clearance for CARESCAPE Patient Data Module for Mobile Patient Monitoring
Devices FDA Monotoring
 HSMN NewsFeed - 24 May 2007
BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for Phenylketonuria (PKU)
Biopharmaceuticals FDA
 HSMN NewsFeed - 24 May 2007
FDA Approves Tindamax(R) for Bacterial Vaginosis
Biopharmaceuticals FDA
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