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FDA Approval Headlines from PR Newswire


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U.S. FDA Cardiovascular and Renal Drugs Advisory Committee Makes Recommendation on Daiichi Sankyo's Once-Daily SAVAYSA™ (edoxaban) for the Reduction in Risk of Stroke and Systemic Embolic Events in Patients with Non-Valvular Atrial Fibrillation
RenovoCath™ RC120 Catheter Receives FDA Clearance
TWi Pharmaceuticals Receives US FDA Approval on Generic Donepezil Hydrochloride Tablets USP, 23 mg, its fifth ANDA from US FDA
Kiadis Pharma's Lead Product ATIR™ Granted Orphan Drug Designation by EMA for the Treatment of Acute Myeloid Leukemia
Flublok® Influenza Vaccine Now Approved for Adults Ages 18 and Older
The National Meningitis Association Applauds FDA Approval of First Serogroup B Meningococcal Disease Vaccine English
InspireMD Investigational Device Exemption (IDE) amendment approved by the FDA
Aethlon Medical Discloses Ebola Treatment Pathways in the United States English
Nephros Receives 510(k) Clearance for DSU-H and SSU-H Ultrafilters
Araim Pharmaceuticals Given FDA Fast Track Designation to ARA 290 for the Treatment of Sarcoidosis-associated Small Fiber Neuropathy
WuXi Congratulates TaiMed Biologics on Receiving Orphan Drug Designation for Ibalizumab from U.S. FDA
Arbor Pharmaceuticals Announces FDA Approval of Sotylize™
Kimberly-Clark Sterilization Wrap Is Now Most Validated On The Market
Harvoni® (ledipasvir/sofosbuvir) approved for the treatment of chronic hepatitis C, genotype 1 infection in adults; Diplomat to distribute
MedNet Solutions To Host Third Annual iMedNet User Group Meeting
BioLight to Present at the Canaccord Genuity 2014 Medical Technology and Diagnostics Forum English
Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes English
Expanding Orthopedics Inc. Granted a New US patent - Adding to its Extensive IP Portfolio of Expandable Bone Devices
Boston Scientific Receives FDA And CE Mark Approval For New CoverEdge™ Surgical Leads For The Precision Spectra™ Spinal Cord Stimulator (SCS) System
U.S. Food and Drug Administration accepts filing of new drug application for empagliflozin/metformin fixed-dose combination
BioSpecifics Technologies Corp. Announces FDA Approval of sBLA for XIAFLEX® for the Concurrent Treatment of Two Dupuytren's Contracture Cords
West's Vial2Bag DC Device Receives U.S. FDA 510(k) Clearance and CE Mark
First Patient Successfully Implanted in Safety/Efficacy Study of Beta-O2's ßAir Bio-Artificial Pancreas for Type 1 Diabetes
Auxilium Pharmaceuticals, Inc. Announces XIAFLEX Now Approved For The Concurrent Treatment Of Up To Two Affected Joints In The Same Hand In Dupuytren's Contracture Patients
Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis
OFEV® (nintedanib) Now Available in the United States
Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex® Recombinant
IMBRUVICA® (ibrutinib) Supplemental New Drug Application Submitted to the U.S. FDA for Waldenstrom's macroglobulinemia
IonMed Receives CE Mark Clearance for Bioweld1™ Cold Plasma System
Taiho Oncology, Inc. Receives FDA Fast Track Designation for TAS-102 as a Potential Treatment for Refractory Metastatic Colorectal Cancer
Pharmacyclics Files Supplemental New Drug Application for IMBRUVICA® for Waldenstrom's Macroglobulinemia
Takeda and Orexigen Announce Availability of CONTRAVE® (naltrexone HCI and bupropion HCI) Extended-Release Tablets for Chronic Weight Management in Obese Adults
Pulmonary Fibrosis Foundation Applauds The Food And Drug Administration's (FDA) Prompt Decision To Approve Esbriet® (pirfenidone) And OFEV® (nintedanib) For The Treatment Of Idiopathic Pulmonary Fibrosis
Esbriet® (pirfenidone) receives FDA approval under 'breakthrough status'; Diplomat to distribute
FDA Approves Boehringer Ingelheim's OFEV® (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis
Konica Minolta Wireless Digital Radiography Solution for Extreme Environments Receives FDA Clearance
FDA Grants Eisai's sNDA for Rufinamide Priority Review as Adjunctive Treatment in Pediatric Patients Ages 1-4 for Seizures Associated with Lennox-Gastaut Syndrome
Breckenridge Pharmaceutical, Inc. Announces Approval of Mefenamic Acid Capsules, USP 250mg
Aethlon Medical Announces First Treatment of an Ebola Patient
BioLight to Present its IOPtiMate™ System at the Ophthalmology Innovation Summit @ the American Academy of Ophthalmology 2014
FDA Approves AKYNZEO® (netupitant/palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
FDA Approves VisionCare's Telescope Implant for Macular Degeneration in Patients 65 Years and Older
FDA Approves AKYNZEO® (netupitant/palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)
Prime Therapeutics responds to FDA approval of Gilead's latest Hepatitis C drug
DURECT Announces POSIDUR™ (SABER®-Bupivacaine) Data Presentation at the American Society of Anesthesiologists Annual Meeting
InSightec to Share Key Insights and Progress at the 4th Focused Ultrasound International Symposium
Alimera Sciences to Present at Ophthalmology Innovation Summit at the American Academy of Ophthalmology Annual Meeting
Astute Medical And CRG Announce FDA Milestone Under Term Loan Agreement
FDA Advisory Committee Panel Votes In Favor Of The WATCHMAN™ Left Atrial Appendage Closure Device
Syneron Announces Launch of PicoWay Picosecond Device for Pigmented Lesion Treatment and Tattoo Removal

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