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FDA Approval Headlines from PR Newswire


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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
Nabriva Therapeutics Announces Qualified Infectious Disease Product and Fast Track Status Granted by the US FDA for Lefamulin
Ferring Pharmaceuticals Inc. Receives FDA Approval For New Cranberry Flavor Of PREPOPIK® (Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid)
Manzo Pharmaceuticals gets confirmation that Lacto-Freedom probiotic is a dietary supplement and will not need FDA approval
EYLEA® (aflibercept) Injection Receives FDA Approval for Macular Edema Following Retinal Vein Occlusion (RVO)
PicoSure® Is FDA-Cleared For Treatment Of Fine Lines And Wrinkles
InSightec Announces HCSC Positive Coverage Decision for its MRgFUS Procedure for Pain Palliation of Bone Cancer Metastases
AbbVie's HUMIRA® (adalimumab) Receives U.S. FDA Approval for Extension of Polyarticular Juvenile Idiopathic Arthritis Indication to Patients Ages 2 and Older
Mylan Launches Generic Combivir®
Elbit Imaging Ltd. Announces That InSightec Announces HCSC Positive Coverage Decision For Its ExAblate Procedure For Pain Palliation Of Bone Cancer Metastases
BioTE's Dr. Donovitz Challenges FDA Panel
B. Braun Receives FDA Approval For New Large-Volume Injection Containers
FDA Grants Fast Track Designation to NKT Therapeutics' NKTT120 for the Treatment of Sickle Cell Disease
Otezla® (apremilast) receives expanded indication; Diplomat to distribute
XTANDI® (enzalutamide) receives expanded approval from FDA for treatment of metastatic castration-resistant prostate cancer
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

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