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FDA Approval Headlines from PR Newswire


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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
FDA approves PleximmuneTM for personalized prediction of transplant rejection in children
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
Beta-O2 Receives Grant from JDRF to Advance Clinical Development of the ßAir Bio-artificial Pancreas as a Potential Cure for Type 1 Diabetes English
FDA Advisory Committee Recommends Against Approval of Actavis' Nebivolol/Valsartan Fixed-Dose Combination NDA for Treatment of Hypertension
New Prevantics® Device Swab from PDI Receives FDA 510k Market Authorization
The Female Health Company Brings Together Advocates and Experts To Advance The FC2 Female Condom
FDA Approves Use of Menactra® Vaccine for Booster Immunization Against Potentially Deadly Disease
Par Pharmaceutical Resumes Shipment of Generic Precedex® Injection
FDA Approves 2 New Indications for Epaned®, the First and Only Enalapril Powder for Oral Solution
Astute Medical to Release First Test for Risk Assessment of Kidney Injury
BerGenBio Granted Platform Patent - CellSelect™ Platform Also Described in Peer-Reviewed Journal
Court Grants Summary Judgment in Favor of Mylan and FDA Related to Generic Precedex™
Astellas Receives Notification from FDA of Acceptance of Filing of Isavuconazole NDA for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis
REVIVE™ SE Thrombectomy Device Approved for Ischemic Stroke Patients in China, South Korea and Taiwan
Prana receives FDA Orphan Drug Designation for PBT2 for Huntington Disease
Mylan Launches Generic Boniva® Injection
FDA Approves Pembrolizumab for Advanced Melanoma
Diplomat to distribute Plegridy™ (peginterferon beta-1a) for treatment of multiple sclerosis
Merck Receives Accelerated Approval of KEYTRUDA® (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
OSE Pharma to Present at the Rodman & Renshaw 16th Annual Global Investment Conference
Cerapedics Files Premarket Approval Application with US FDA for i-FACTOR™ Peptide Enhanced Bone Graft
Debiopharm Group™'s Innovative Antibiotic Debio 1450 - Developed From its Proprietary Platform Fabiotics - Receives Qualified Infectious Disease Product (QIDP) Designation from the FDA
NeuroDerm Announces Start of Phase 2a Study of Continuous Subcutaneous Liquid Levodopa/Carbidopa Administration for Patients with Severe Parkinson's Disease
Diplomat to distribute SYNRIBO® (OMACETAXINE MEPESUCCINATE) for Injection
Halozyme's PEGPH20 Program In Metastatic Pancreatic Cancer Receives Fast Track Designation English
Oramed to Present at Upcoming Conferences
Ajinomoto Althea, Inc. Receives European GMP Certification
Data From Global Atrial Fibrillation Registry Show Antithrombotic Agents Not Optimally Used to Prevent Stroke
Ortho Development Receives FDA Clearance for Alpine Hip Stem
First Surgery Worldwide Performed with Expanding Orthopedics' FLXfit™ 3D Expandable Interbody Cage
VentiRx Pharmaceuticals Announces Fast Track Designation Granted for Motolimod (VTX-2337), a Novel Immunotherapy for Women with Ovarian Cancer
Sophia Genetics Becomes the First European Company to Obtain CE-IVD Mark for Clinical use of Next Generation Sequencing Bioinformatics Pipeline for Routine Genetic Testing
New indication for VIMPAT® (lacosamide): UCB's anti-epileptic drug approved by FDA as monotherapy in the treatment of patients with partial-onset seizures
InnoPharma Announces FDA Approval of Decitabine for Injection, a Generic Version of DACOGEN®
Nonin Medical Announces FDA Clearance of Nonin Model 3231 USB Pulse Oximeter
Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA
TWi Pharmaceuticals Receives US FDA Final Approval on Generic Megestrol Acetate 125mg/ml Oral Suspension
USC Eye Institute ophthalmologists implant first FDA-approved Argus II retinal prosthesis in western United States
FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure
Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients with Cervical Complete Spinal Cord Injury
GSK receives FDA approval of an additional Promacta® (eltrombopag) indication for use in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST)

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