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Clinical - Approvals
NovoCure Release: FDA Approves Optune In Combination With Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma 10/9/2015
SentreHEART Receives CE Mark Approval For The LARIAT Surgical Left Atrial Appendage Suture Delivery Device 10/8/2015
Carestream Health Obtains FDA Clearance For Diagnostic Reading Of ECG Waveforms On Mobile Tablets Using Vue Motion Viewer 10/8/2015
Marrone Bio Innovations, Inc Receives EPA Approval For MAJESTENE Bionematicide 10/8/2015
Teva (TEVA) Announces Approval Of Three-Times-A-Week COPAXONE 40 Mg/Ml In Russia For The Treatment Of Relapsing-Remitting Multiple Sclerosis 10/8/2015
Avita Medical Snags CE Mark for ReGenerCell and ReNovaCell to Complete Skin Healing Portfolio 10/7/2015
LONSURF (Trifluridine And Tipiracil) Approved For Refractory Metastatic Colorectal Cancer, Available At Biologics, Inc. (NC) 10/7/2015
FDA Green Lights Alkermes (ALKS)' Schizophrenia Treatment Aristada 10/7/2015
Gilead (GILD) Scores FDA Approval of Letairis Combo as PAH Treatment 10/6/2015
McGuff Pharmaceuticals, Inc. Announces FDA Approval For Hydroxyprogesterone Caproate Injection, USP (HPC). 10/6/2015
FDA Clears Corindus Vascular Robotics's CorPath System for Robotic-assisted Radial Access PCI Procedures 10/6/2015
Hitachi Medical Systems America Announces FDA Clearance of High-Value Supria 16-Slice CT System 10/6/2015
InspireMD Ltd. Announces CGuard Approval In Columbia 10/5/2015
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of DIABETA (Glyburide) Tablets, USP, 1.25 Mg, 2.5 Mg, And 5 Mg 10/5/2015
NovoCure Grabs CE Mark and First Patient Use of Second Generation Optune System 10/5/2015
Dako (A) Snags FDA Approval of New Companion Diagnostic for Lung Cancer 10/5/2015
Bay Area's EBR Systems Wins CE Mark Approval for World’s First Wireless Cardiac Pacing System for Heart Failure 10/5/2015
Inspirion Delivery Technologies Receives FDA Approval For MorphaBond (morphine sulfate) Extended-Release Tablets CII, An Opioid Analgesic Formulated With Abuse-Deterrent Properties 10/5/2015
Irvine Scientific Receives CE Mark Approval For Human Serum Albumin 10/5/2015
FDA Green Lights Merck & Co. (MRK)'s’s Keytruda for Most Common Form of Lung Cancer 10/2/2015
FDA Green Lights Bristol-Myers Squibb (BMY)'s Drug Combo for Metastatic Melanoma 10/2/2015
Allergan (AGN) Release: U.S. FDA Approves JUVEDERM ULTRA XC For Use In Lips 10/1/2015
SpineGuard Receives CE Mark For New Application Of Its Disruptive DSG (Dynamic Surgical Guidance) Platform 9/30/2015
As Spinoff Rumors Spin, Sanofi (SNY)’s Cholesterol Drug Praluent Gets Approval in Europe 9/29/2015
UVLrx Therapeutics Wins CE Marking for Intravenous UV Light Therapy Device 9/29/2015
AbbVie (ABBV)'s VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval In Japan For The Treatment Of Genotype 1 Chronic Hepatitis C 9/28/2015
Merck & Co. (MRK)'s Once-Weekly Diabetes drug MARIZEV Approved in Japan 9/28/2015
Enanta Pharmaceuticals, Inc. Announces Approval Of VIEKIRAX (Ombitasvir/Paritaprevir/Ritonavir Tablets) In Japan For The Treatment Of Genotype 1 Chronic Hepatitis C 9/28/2015
Teva (TEVA) Announces Approval Of COPAXONE In Japan For The Prevention Of Relapse Of Multiple Sclerosis 9/28/2015
Takeda Pharmaceutical Co. Ltd. (TKPYY): New Drug Application Approval In Japan For Copaxone Subcutaneous Injection 20 Mg Syringe, A Drug For The Treatment Of Multiple Sclerosis 9/28/2015
Novo Nordisk A/S (NVO) Finally Bags Diabetes Drug Tresiba U.S. Approval 9/28/2015
Keryx (KERX) Receives European Approval For Fexeric (Ferric Citrate Coordination Complex) For The Treatment Of Hyperphosphatemia In Adults With Chronic Kidney Disease 9/24/2015
Medical Developments International Limited Release: Green Whistle Receives Regulatory Approval In Singapore 9/24/2015
Starpharma Release: EU Marketing Approval Granted For VivaGel BV 9/24/2015
Camber Pharma Launches Generic Nexium Delayed-Release Capsules 9/24/2015
B. Braun Medical Receives FDA Clearance for Infusomat Space Pump 9/23/2015
Implanet: New JAZZ Band FDA Clearance Expands Posterior Fixation System Selection 9/23/2015
Taiho Oncology Announces FDA Approval Of LONSURF (Trifluridine And Tipiracil) For Refractory Metastatic Colorectal Cancer (mCRC) 9/23/2015
VolitionRX Wins First CE Mark for NuQ Blood Assay for Colorectal Cancer Detection 9/22/2015
Ceterix Orthopaedics Wins FDA Approval for Next-Gen Meniscus Repair Device 9/22/2015
St. Jude Medical (STJ) Grabs CE Mark for the New Infinity Deep Brain Stimulation System and Directional DBS Lead 9/22/2015
Bayer (BAY) Introduces New Single-Dose Treatment For Canine Otitis Externa 9/22/2015
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of Testred C-III (Methyltestosterone Capsules, USP), 10 Mg 9/22/2015
Perrigo (PRGO) Announces FDA Approval And Launch Of The AB Rated Generic Version Of Benzaclin Topical Gel 9/22/2015
Shire (SHPG) Receives European Approval For INTUNIV (Guanfacine) Hydrochloride Prolonged Release Tablets) As A Non-Stimulant ADHD Treatment For Children And Adolescents 9/21/2015
Eli Lilly (LLY) Release: New Gastric Cancer Medicine Approved And Available For Use In Canada 9/21/2015
Specialised Therapeutics Australia' Breakthrough Brain Tumour Visualisation Drug GLIOLAN Approved For Use In New Zealand 9/18/2015
Full Product Approval In Japan Received By Mesoblast (MSB.AX) Licensee 9/18/2015
FDA Approves Allergan (AGN) and Gedeon Richter (RIG2.F)'s Antipsychotic Vraylar 9/18/2015
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of Mestinon Timespan Tablets, 180 Mg 9/17/2015
FDA Green Lights Octapharma USA's NUWIQ for Hemophilia A 9/15/2015
Health Canada Approves Amgen (AMGN)'s New Cholesterol-Lowering Medication Repatha (evolocumab) 9/15/2015
AbbVie (ABBV) Snags Another Win for Humira 9/14/2015
Allergan (AGN) And Perrigo (PRGO) Receive FDA Approval Of Three Extended Release Products Equivalent To Mucinex And Mucinex DM 9/11/2015
Xtant Medical Announces FDA Clearance of the Aranax Cervical Plate 9/9/2015
BioLineRx Ltd.’s Novel Treatment For Non-Surgical Removal Of Skin Lesions Submitted For CE Mark Registration 9/9/2015
Thermo Fisher Scientific (TMO) Receives IVDD CE Mark for its Thermo Scientific Prelude MD HPLC, Endura MD Mass Spectrometer and ClinQuan MD Software 9/8/2015
Nanosphere Grabs FDA Approval for First-of-Its-Kind Flexible Respiratory Pathogens Test 9/8/2015
New Haven Pharmaceuticals Receives FDA Approval For DURLAZA (Aspirin) Extended Release Capsules For Secondary Prevention Of Stroke And Acute Cardiac Events 9/8/2015
Merck & Co. (MRK) And Samsung Bioepis Announce Approval Of BRENZYS (Etanercept), A Biosimilar Of Enbrel, In Korea 9/8/2015
Wellstat Therapeutics Corporation Announces FDA Approval Of XURIDEN To Treat Rare Pediatric Disorder Hereditary Orotic Aciduria (HOA) 9/8/2015
AstraZeneca PLC (AZN) Wins FDA Green Light for Long-Term Brilinta Use in U.S. 9/4/2015
Teleflex Incorporated (TFX) Snags FDA Nod for the ARROW® Triple Lumen Pressure Injectable Acute Hemodialysis Catheter 9/3/2015
Salutaris Medical Devices Announces 510(k) Clearance 9/3/2015
Sandoz Canada Release: Health Canada Approves New Indications For Promnitrope (Somatropin), Canada's First Subsequent Entry Biologic (Biosimilar) 9/3/2015
Allergan (AGN) Announces FDA Approval Of Updated Label For TEFLARO (ceftaroline fosamil) 9/2/2015
Wright Medical Group (WMGI) Wins FDA Approval for AUGMENT Bone Graft 9/2/2015
Merck & Co. (MRK) Release: FDA Approves Pediatric Indication For EMEND (Aprepitant) Capsules In Combination With Other Antiemetic Agents 9/2/2015
Ligand (LGND) Release: Revolade Receives EU Approval As First-In-Class Therapy For Patients With Severe Aplastic Anemia 9/2/2015
Janssen Biotech Inc. (JNJ) Release: U.S. FDA Approves Update Of SIMPONI ARIA (golimumab for infusion) Label To Include Improvement In Both Physical And Emotional Measures Of Health When Treating Moderately To Severely Active Rheumatoid Arthritis 9/2/2015
Tesaro (TSRO) Wins FDA Nod for Chemotherapy-Induced Nausea Drug Varubi 9/2/2015
Surefire Wins FDA Approval for Precision Direct-to-Tumor Embolization Device 9/1/2015
Alexion (ALXN) Release: European Commission Grants Marketing Authorization For Strensiq (Asfotase Alfa) For The Treatment Of Patients With Pediatric-Onset Hypophosphatasia (HPP) 9/1/2015
Alexion (ALXN) Release: European Commission Grants Marketing Authorization For Kanuma (Sebelipase Alfa) For The Treatment Of Patients Of All Ages With Lysosomal Acid Lipase Deficiency (LAL-D) 9/1/2015
ZEISS Sets The Pace In OCT Innovation With First FDA 510(K) Clearance Of OCT Angiography Technology 9/1/2015
FDA Approval of Amgen (AMGN)’s Cholesterol Drug Repatha Could Boost Job Growth on East Coast 9/1/2015
Sunovion Pharmaceuticals Inc. Announces FDA Approval Of A New Indication For Aptiom (Eslicarbazepine Acetate) As Monotherapy For Partial-Onset Seizures 8/31/2015
MagVenture's Major Depressive Disorder Therapy System Wins FDA Approval 8/28/2015
FDA Approves Amgen (AMGN)'s New Cholesterol-Lowering Medication Repatha (evolocumab) 8/28/2015
Sunovion Pharmaceuticals Inc. Announces FDA Approval Of A New Indication For Aptiom (Eslicarbazepine Acetate) As Monotherapy For Partial-Onset Seizures 8/28/2015
Exelixis (EXEL) Announces First Regulatory Approval Of Cobimetinib In Switzerland 8/27/2015
Boehringer Ingelheim Release: U.S. FDA Approves Synjardy (empagliflozin/metformin hydrochloride) Tablets For Adults With Type 2 Diabetes 8/27/2015
Bacterin's Xtant Medical Wins FDA Approval of OsteoSelect PLUS 8/25/2015
Ligand (LGND) Release: FDA Expands Use Of Promacta To Include Treatment Of Children Ages 1 And Older With Chronic Immune Thrombocytopenia 8/25/2015
FDA Approves Expanded Use of Promacta for Novartis AG (NVS) 8/25/2015
St. Jude Medical (STJ) Wins CE Mark for Prodigy MRI with Select Leads 8/24/2015
FDA Green Lights Boston Scientific (BSX)'s Innova Stent for Peripheral Artery Disease 8/20/2015
Sprout's First-Ever Female Libido Drug Comes With Boxed Warning and Controversy 8/20/2015
Sprout Receives FDA Approval of ADDYI (Flibanserin 100 MG) 8/19/2015
Swedish Orphan Biovitrum Release: Kineret Receives Australian Regulatory Approval For Use In Systemic Juvenile Idiopathic Arthritis 8/19/2015
Sprout to Expand to 200 Employees After FDA Approval of Female Sex-Drive Drug 8/19/2015
Lannett (LCI) Receives FDA Approval, Launches Generic Antidepressant Drug ABILIFY 8/18/2015
Aurora Spine Wins CE Mark Approval for Sterile-Packed TiNano Coated Interbody Systems 8/18/2015
Seattle Genetics (SGEN) Announces FDA Regular Approval Of ADCETRIS (Brentuximab Vedotin) For Classical Hodgkin Lymphoma Patients At High Risk Of Relapse Or Progression As Post-Autologous Hematopoietic Stem Cell Transplantation Consolidation 8/18/2015
Raptor Pharmaceutical Inc. (RPTP) Receives FDA Approval Of Expanded Label For PROCYSBI To Treat Children Aged 2-6 Years With Nephropathic Cystinosis 8/17/2015
GE Healthcare First to Win FDA Approval for Low Dose CT Lung Cancer Screening 8/17/2015
Alexion Pharma Canada Release: Health Canada Approves Strensiq (asfotase alfa), The First Therapy For Patients With Hypophosphatasia (HPP), An Ultra-Rare, Life-Threatening Disease 8/17/2015
Baxter International (BAX) And Water Street Announce FDA Approval Of CEFAZOLIN 2 Gram Premix 8/14/2015
BioDelivery Sciences International (BDSI) Announces FDA Approval Of New Formulation Of ONSOLIS (fentanyl buccal soluble film) CII 8/13/2015
Octapharma USA, Inc.: FDA Approves WILATE License Supplement – Perioperative Management Of Bleeding In Patients With Von Willebrand Disease 8/13/2015
Biogen Canada Inc. Release: Health Canada Approves PLEGRIDY (peginterferon beta-1a) For Adults With Relapsing Remitting Multiple Sclerosis 8/13/2015
Apollo Endosurgery's Gastric Balloon for Obesity Wins FDA Approval 8/12/2015
Uptake Medical Receives CE Mark Approval For InterVapor Targeted Ablation Therapy For Severe Emphysema 8/12/2015
Orexo AB (ORXOF) Wins FDA Approval for ZUBSOLV 8/11/2015
Apricus Biosciences (APRI) Announces Approval Of Vitaros For The Treatment Of Erectile Dysfunction In Twelve Additional Countries 8/10/2015
Upsher-Smith Laboratories Receives FDA Approval For Generic Version Of Namenda (Memantine HCl) Tablets 8/10/2015
Stryker Wins FDA Approval for MAKO (MAKO)'s Total Knee Application 8/10/2015
Health Canada Approves he Glaukos iStent inject 8/10/2015
FDA Approves Taro Pharmaceutical Industries Ltd. (TARO)’s Keveyis (Dichlorphenamide) 50 Mg Tablets For Primary Hyperkalemic And Hypokalemic Periodic Paralysis 8/10/2015
FDA Clears Seven-Day Platelet Storage And Wireless Capability For The Trima Accel System From Terumo BCT 8/10/2015
GlaxoSmithKline (GSK) Receives Approval For BREO ELLIPTA For The Treatment Of Adults With Asthma 8/7/2015
FDA Green Lights First 3D Printed Drug From Aprecia 8/6/2015
BTG plc (BTG.L) Release: Health Canada Approves Varithena (Polidocanol Injectable Foam) For Patients With Varicose Veins 8/6/2015
Bio Products Laboratory Limited Release: Gammaplex Approved For Use In Pediatric Patients 8/6/2015
Sorin Group S.p.A. (SRN) Obtains Health Canada Approval for Perceval, Its Next Generation Sutureless Valve 8/5/2015
TriVascular, Inc. (TRIV) Wins FDA Approval Of The Ovation Ix Abdominal Stent Graft System 8/4/2015
Ulthera Snags Two Year FDA Clearance for Cellfina System 8/3/2015
Fresenius Kabi AG Wins FDA Clearance For 7-Day Platelet Storage Using Fenwal Amicus System 8/3/2015
OraSure Technologies, Inc. (OSUR) Snags FDA Emergency Use Authorization for Ebola Rapid Diagnostic Test 8/3/2015
Roche (RHHBY)’s Perjeta Regimen Approved In Europe For Use Before Surgery In Early Stage Aggressive Breast Cancer 7/31/2015
FDA Approves Bayer HealthCare (BAY)'s Finacea (Azelaic Acid) Foam, 15% For The Topical Treatment Of The Inflammatory Papules And Pustules Of Mild To Moderate Rosacea 7/31/2015
Bayer HealthCare (BAY) and Foamix Pharmaceuticals, Ltd. (FOMX) Release: Finacea (Azelaic Acid) Foam 15%, Approved By U.S. FDA For Topical Treatment Of The Inflammatory Papules And Pustules Of Mild To Moderate Rosacea 7/31/2015
NeuWave Medical Wins FDA Nod for Ablation Confirmation Software 7/30/2015
Japanese Approval Trial For Stress Urinary Incontinence Using Cytori Therapeutics, Inc. (CYTX) Cell Therapy Announced 7/30/2015
Glaukos Receives Regulatory Approval In Australia For Istent Inject 7/30/2015
Teleflex Incorporated (TFX) Release: ARROW Endurance Extended Dwell Peripheral Catheter System Receives FDA Market Clearance 7/30/2015
FDA Green Lights ReShape Medical's Weight Loss Stomach Balloon 7/29/2015
Bay Area's C2 Therapeutics Wins FDA Nod for the Coldplay Cryoballoon Full and Swipe Ablation Systems 7/29/2015
Breckenridge Pharmaceutical, Inc. Announces Approval For Azelastine HCl Nasal Solution (Nasal Spray) 7/29/2015
Corvida Medical Receives FDA 510 Clearance for Halo Closed System Transfer Device 7/29/2015
EMBA Medical Limited Awarded CE Certificate For Hourglass Peripheral Embolization Plug 7/29/2015
Juniper Pharmaceuticals Announces Regulatory Approvals For CRINONE Progesterone Gel In Nine New EU Countries 7/28/2015
Bristol-Myers Squibb (BMY) Release: FDA Approves Daklinza (Daclatasvir) For The Treatment Of Patients With Chronic Hepatitis C Genotype 3 7/27/2015
ANI Pharma And Sofgen Pharmaceuticals Announce FDA Approval Of Nimodipine 30mg Capsules 7/27/2015
TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA Approval As The First And Only All-Oral, Interferon-Free Treatment For Genotype 4 Chronic Hepatitis C In The U.S. 7/24/2015
Enanta Pharmaceuticals, Inc. Announces U.S. Regulatory Approval Of TECHNIVIE (Ombitasvir, Paritaprevir And Ritonavir) Tablets 7/24/2015
Bristol-Myers Squibb (BMY) Release: FDA Approves Daklinza (Daclatasvir) For The Treatment Of Patients With Chronic Hepatitis C Genotype 3 7/24/2015
FDA Approves Cholesterol Drug Praluent From Regeneron (REGN), Sanofi (SNY) 7/24/2015
Amgen (AMGN) Release: FDA Approves Kyprolis (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma 7/24/2015
FDA Approves Novartis AG (NVS) Drug Odomzo (sonidegib) For Locally Advanced Basal Cell Carcinoma (laBCC), A Form Of Skin Cancer 7/24/2015
Theravance (THRX) Announces Health Canada Approval For VIBATIV (telavancin) for Treatment of HAP/VAP Caused By Gram-Positive Bacteria, Including MRSA 7/23/2015
Medrobotics Receives FDA Clearance To Market Flex Robotic System 7/23/2015
Amgen (AMGN) Beats Sanofi (SNY)/Regeneron (REGN) to European Market for Cholesterol Drug, but Race is Still on for U.S. Market 7/23/2015
European Commission (EC) Approves Merck & Co. (MRK)'s Anti-PD-1 Therapy, KEYTRUDA (Pembrolizumab), For Both First-Line And Previously-Treated Patients With Advanced Melanoma 7/22/2015
European Commission (EC) Approves Amgen (AMGN)s New Cholesterol-Lowering Medication Repatha (Evolocumab), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholesterol 7/21/2015
St. Jude Medical (STJ) Snags FDA Nod for Industry's Only MR-Conditional 5-Column Paddle Lead for the Management of Chronic Pain 7/20/2015
BioSpecifics Technologies Corporation (BSTC) Announces Approval Of XIAFLEX In Japan For The Treatment Of Dupuytren's Contracture 7/20/2015
Meridian Bioscience (VIVO) Snags FDA OK for New Molecular Amplification Test: illumigene HSV 1&2 7/20/2015
Galderma Canada Release: Novel Rosacea Treatment Approved By Health Canada For Adult Patients 7/20/2015
Bristol-Myers Squibb (BMY) Release: European Commission (EC) Approves Nivolumab BMS, The First PD-1 Immune Checkpoint Inhibitor In Europe Proven To Extend Survival For Patients With Previously-Treated Advanced Squamous Non-Small Cell Lung Cancer 7/20/2015
Galderma Laboratories Receives FDA Approval For New Antibiotic-Free Treatment Option For Acne Patients 7/17/2015
Ipsen (IPN.PA) Announces FDA Approval Of Dysport(Abobotulinumtoxina) For Injection In The Treatment Of Upper Limb Spasticity In Adults In The United States 7/17/2015
St. Jude Medical (STJ) Receives FDA Approval For The Industry's First Spinal Cord Stimulation Trial System To Incorporate Bluetooth® Wireless Technology And Apple Digital Devices 7/16/2015
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s Evotaz (Atazanavir And Cobicistat Fixed-Dose Combination) For The Treatment Of HIV-1 Infection In Adults 7/16/2015
Novo Nordisk A/S (NVO) Receives FDA Approval For FlexPro PenMate For People With Growth Hormone-Related Disorders 7/16/2015
Merz Pharma Canada Ltd. Announces The Approval Of Radiesse (+) With Integral 0.3% Lidocaine 7/15/2015
Summit Medical Nears Completion Of 510(K) Goals With FDA Clearance For Additional Sterilization Cycles 7/15/2015
FDA Green Lights AstraZeneca PLC (AZN)'s Lung Cancer Drug Iressa 7/14/2015
Veloxis Pharmaceuticals A/S (VELO) Announces U.S. FDA Approval of Envarsus XR For Treatment Of Kidney Transplant Patients 7/13/2015
FDA Clearance For joimax Endolif On-Cage: 3D-Printed Fusion Implant 7/13/2015
Otsuka Pharma, H. Lundbeck A/S (LUN.CO) Beat Competitors With FDA Approval of Schizophrenia Drug 7/13/2015
AbbVie (ABBV) Release: IMBRUVICA (ibrutinib) Now Approved To Treat Waldenstrom's Macroglobulinemia In Europe 7/10/2015
Lexmark Healthcare Receives FDA 510(k) Class II Clearance For NilRead Enterprise Viewer 7/9/2015
COPD Foundation Release: FDA Approves First COPD Biomarker: Paving Way For New, Improved Treatments And Cures 7/9/2015
B.Braun Medical Wins FDA Approval for 70% Dextrose Injection, USP 7/9/2015
IGI Laboratories, Inc. Announces FDA Approval And Commercial Launch Of Diclofenac Sodium, 1.5% 7/9/2015
Novartis AG (NVS) Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20% 7/9/2015
Novartis AG (NVS)' New Heart Failure Medicine LCZ696, Now Called Entresto(TM), Approved By FDA To Reduce Risk Of Cardiovascular Death And Heart Failure Hospitalization 7/8/2015
Vanda Pharmaceuticals, Inc. (VNDA) Release: HETLIOZ Receives European Commission Approval For The Treatment Of Non-24-Hour Sleep-Wake Disorder In The Totally Blind 7/8/2015
Protein Sciences Corporation Receives Approval from FDA For 2015/16 Formulation Of Flublok Influenza Vaccine 7/8/2015
Easton Pharmaceuticals (OP: EAPH) / BMV Medica Announces Its Mexican Ministry Of Health And Latin America Regulatory Filing And Approval Process For Cancer Drugs Paclitaxel And Docetaxel From Biolyse Pharma Has Been Shortened 7/7/2015
Vertex (VRTX) Gets FDA Approval for $259K Per Year CF Drug 7/7/2015
Vertex (VRTX) Release: FDA Approves ORKAMBI (Lumacaftor/Ivacaftor) - The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis For People Ages 12 And Older With Two Copies Of The F508del Mutation 7/6/2015
Kubtec Announces FDA Approval of DIGIVIEW 395 High Resolution Wireless Flat Panel Detector 7/6/2015
Alexion (ALXN) Release: Strensiq (asfotase alfa) Receives Marketing Approval In Japan For Treatment Of Patients With Hypophosphatasia (HPP) 7/6/2015
Japan’s Ministry Of Health, Labour And Welfare Approves Gilead (GILD)’s Harvoni, The First Once-Daily Single Tablet Regimen For The Treatment Of Genotype 1 Chronic Hepatitis C 7/6/2015
Galderma Receives FDA Approval To Market Restylane Lyft With Lidocaine To Correct Age Related Volume Loss In The Cheek Area 7/2/2015
Proteus Digital Health Release: First Medical Device Cleared By FDA With Adherence Claim 7/2/2015
Boehringer Ingelheim Release: New Advance In COPD Maintenance Treatment, Spiolto Respimat, Approved In First European Countries 7/2/2015
Spriaso Announces Approval Of New Drug Application For The Long Acting Codeine Antitussive With A Popular Anti-Histamine 7/1/2015
GlySure Secures CE Mark And Launches World’s First Continuous Intravascular Glucose Monitoring System 7/1/2015
SpineGuard Obtains Regulatory Clearance To Sell Pediguard In The World’s Second-Largest Spine Market: China 6/30/2015
New Indication For Teijin Pharma’s Febuxostat In Europe 6/30/2015
Exactech (EXAC) Grabs FDA Approval for Its Optetrak Logic Constrained Condylar Prosthesis 6/29/2015
Caldera Medical Announces FDA Clearance For New Generation Of Vertessa Lite Polypropylene Mesh For Sacrocolpopexy 6/29/2015
Swedish Orphan Biovitrum Release: European Commission (EC) Approves Orfadin Oral Suspension 6/29/2015
Regeneron (REGN) Release: EYLEA (aflibercept) Injection Receives Approval In Japan For The Treatment Of Retinal Vein Occlusion 6/26/2015
Merck & Co. (MRK) Release: SIMPONI Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis 6/26/2015
FDA Approves The Medicines Company (MDCO)'s Blood Clot Drug KENGREAL 6/24/2015
FDA Green Lights Eisai Inc. (ESALF.PK)'s FYCOMPA for Adjunctive Therapy in the Treatment of Primary Generalized Tonic-Clonic Seizures in Patients with Epilepsy Age 12 and Older 6/22/2015
Amphastar Pharmaceuticals, Inc. (AMPH) Receives Approval For AMPHADASE Supplement, Marking The First Product From Its China Facility 6/22/2015
Wockhardt (WOCKHARDT.BO) Receives ANDA Approval For Pain Medication Oxycodone Liquid 6/22/2015
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab), The First And Only PD-1 Checkpoint Inhibitor Approved In Europe, For Both First-Line And Previously-Treated Advanced Melanoma Patients 6/19/2015
Admedus Granted Cardiocel Approval In Singapore 6/18/2015
IMPAX Labs (IPXL) Release: FDA Approves ZOMIG (zolmitriptan) Nasal Spray For Migraine In Pediatric Patients (Ages 12-17) 6/16/2015
Novartis AG (NVS) Gains FDA Approval For Promacta Providing New Option For Children, Ages 6 And Older, With Chronic ITP, A Rare Blood Disorder 6/12/2015
Ligand Pharmaceuticals Inc. (LGND) Release: FDA Approves Promacta For New Pediatric Chronic Immune Thrombocytopenia (Citp) Indication 6/12/2015
Merz North America Announces FDA Approval Of Radiesse For Use In The Hands 6/5/2015
FDA Green Lights NovaBay (NBY)’s New High-Tech Device intelli-Case 6/4/2015
Valeant (VRX) Release: RELISTOR Receives European Approval For Expanded Indication To Treat All Opioid-Induced Constipation 6/3/2015