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FDA Approval Headlines from PR Newswire

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CSL Behring Expands Manufacturing Facility In Kankakee, Illinois To Meet Patients' Growing Needs
ELDOR Spinal Needle (CSEN International Ltd.) - The Perfect Needle for Spinal Anesthesia
Synapse Biomedical Announces the Early Completion of Enrollment in the FDA Post Approval Study for ALS Patients
LapSpace Nears Market Entry with Completion of FIM Surgical Procedures
Par Pharmaceutical Begins Shipment of Generic Exforge®
Luminex Receives FDA Clearance To Add New Clinical Targets And Additional Sample Type For Use With xTAG® Gastrointestinal Pathogen Panel
Occlutech Obtains European CE Approval for its Dedicated Paravalvular Leak Closure Device
Clinical Study Results of LifeBond's LifeSeal™ Surgical Sealant for GI Surgeries Announced at the ESCP's 9th Scientific & Annual Meeting
Alimera Sciences Provides Details On FDA Approval Of ILUVIEN® As The First Long-Term Treatment For Diabetic Macular Edema
Clinical Study Results of LifeBond's LifeSeal™ Surgical Sealant for GI Surgeries Announced at the ESCP's 9th Scientific & Annual Meeting
CytRx Receives Multiple FDA Orphan Drug Designations for Aldoxorubicin for the Treatment of Glioblastoma, Small Cell Lung Cancer and Ovarian Cancer English
ZYTIGA® Plus Prednisone Demonstrates Statistically Significant Overall Survival After 49-Month Follow-Up Analysis in Chemotherapy-Naive Men with Metastatic Castration-Resistant Prostate Cancer
Pivotal Phase III Trial Data for Anamorelin in ROMANA 1 and 2 Studies in Non-Small Cell Lung Cancer Patients with Anorexia-Cachexia Shows Significant Increase in Lean Body Mass, Body Weight and Improved Symptoms
Alimera Sciences Receives FDA Approval For ILUVIEN®, The First Long-Term Treatment For Diabetic Macular Edema
Presented by the Japanese Cancer Association and Debiopharm Group™, the 'JCA-Mauvernay Award 2014' goes to Doctors Hara and Shibata
Clear Guide Medical Receives FDA 510(k) Clearance on First Product, the CLEAR GUIDE ONE
CorMedix Announces FDA IND Filing for Neutrolin® in United States
AbbVie's HUMIRA® (adalimumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderately to Severely Active Crohn's Disease
Boehringer Ingelheim Announces FDA Approval of Spiriva® Respimat® (tiotropium bromide) Inhalation Spray for the Maintenance Treatment of COPD
Bausch + Lomb and Nicox's Glaucoma Candidate VESNEO® (latanoprostene bunod) Meets Primary Endpoint in Phase 3 Studies
Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle® (Estradiol Transdermal System)
RDT Announces Significant Market Clearances for its Tempus Pro™ Advanced Medical Monitor
Unisense FertiliTech A/S Receives FDA Clearance for Tool to Aid in Embryo Selection to Improve IVF Treatment
Cynosure Receives Expanded FDA Clearance to Market PicoSure® for Treatment of Wrinkles
Anesthesia Safety Products Announces FDA De Novo Clearance to Market the AirPurge™ System for Automatic Removal of Air Bubbles in I.V. Lines
FDNA to Exhibit at ASHG2014 Presenting Face2Gene Integrated With London Medical Databases (LMD) Online
Equashield Enters Taiwan Following Expansion to Australia, Japan, China
Cerevast Therapeutics Announces Outcome of First Interim Analysis of Phase 3 CLOTBUSTER Trial for the Treatment of Acute Ischemic Stroke
Amgen Submits Biologics License Application for Investigational BiTE® Immunotherapy Blinatumomab
FDA Approves Trulicity™ (dulaglutide), Lilly's Once-Weekly Therapy for Adults with Type 2 Diabetes English
VIVUS And Auxilium Announce FDA Approval Of STENDRA sNDA; STENDRA Now First And Only Oral Erectile Dysfunction Treatment Approved To Be Taken Approximately 15 Minutes Before Sexual Activity
Latest Data Shows OrbusNeich's COMBO™ Dual Therapy Stent has Excellent Healing Benefits
Debiopharm Diagnostics Portfolio Company Biocartis Ships its First Idylla Instrument
FDA Approves MOVANTIK™ (naloxegol) Tablets For The Treatment Of Opioid-Induced Constipation In Adult Patients With Chronic Non-Cancer Pain English
NxStage Announces FDA Clearance of Single Needle Technology
NeuroDerm Ltd. Files Registration Statement for Proposed Initial Public Offering
Cochlear Announces the FDA Approval of True 2.4 GHz Wireless Connectivity With the Cochlear™ Nucleus® 6 Sound Processor
Shire Announces FDA Acceptance for Filing with Priority Review of Supplemental New Drug Application (sNDA) for Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) for Adults with Binge Eating Disorder
FDA accepts Tuzistra™ XR (CCP-01) NDA for full review
FDA Approves New Styles Of The MENTOR® MemoryShape® Silicone Breast Implant
Synthetic Biologics Receives Orphan Drug Designation for SYN-005 Treatment for Whooping Cough (Pertussis)
7 Things About Artificial Hearts That You Should Know
ADAMA Achieves U.S. Registration for Novel NIMITZ[TM] Nematicide
IMRIS neurosurgical HFD rocker arm receives FDA clearance English
Takeda and Orexigen Announce FDA Approval of Contrave® (naltrexone HCI and bupropion HCI) Extended-release Tablets for Chronic Weight Management
U.S. FDA Approves New Indication for the Use of XTANDI® (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer
Merck & Co.'s Keytruda is Approved in the United States for the Treatment of Advanced and Unresectable Malignant Melanoma
Glen Tullman Launches Livongo Health™ to Empower Consumers with Chronic Conditions to Live Better, Beginning with Diabetes
Global Kinetics Corporation Announces FDA Clearance of the Personal KinetiGraph™ for Assessment of Parkinson's Disease Symptoms English
BioLight Announces First IOPtiMate™ System Sale in Hong Kong

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