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Clinical - Approvals (World)
Eisai Company (ESALY.PK): Additional Dosage And Administration Of Proton Pump Inhibitor Pariet (R) 5 Mg Tablets, 10 Mg Tablets Approved In Japan For Maintenance Therapy Of Proton Pump Inhibitor Resistant Reflux Esophagitis 9/22/2017
BrainLAB AG Snags FDA Win for Two New Indication-Specific Radiosurgery Software Applications 9/21/2017
Perrigo (PRGO) Announces FDA Final Approval For Its AB Rated Generic Version Of Exalgo 32mg Extended Release Tablets 9/21/2017
Lexicon Pharma (LXRX) Release: European Commission (EC) Approves XERMELO (Telotristat Ethyl) For The Treatment Of Carcinoid Syndrome Diarrhea In Combination With Somatostatin Analog Therapy 9/20/2017
Novartis AG (NVS) Drug Rydapt (Midostaurin) Receives EU Approval For Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) And Three Types Of Advanced Systemic Mastocytosis (SM) 9/20/2017
GlaxoSmithKline (GSK) Investors Rejoice After Winning A Much-Needed OK For Triple COPD Drug Inhaler 9/19/2017
Cycle Pharma Receives FDA Approval And Launches Ketorolac Tromethamine Injection 30mg/ml In The U.S. 9/19/2017
Ipsen (IPN.PA) Receives Approval From European Commission (EC) For Xermelo (Telotristat Ethyl) For The Treatment Of Carcinoid Syndrome Diarrhea In Patients Inadequately Controlled By Somatostatin Analogue Therapy 9/19/2017
Amgen (AMGN), Allergan (AGN) Make History With First Cancer Biosimilar OK—Will Take on Genentech (RHHBY)'s $6 Billion Best-Seller 9/18/2017
U.S. FDA Approves New Indication For Ipsen (IPN.PA)'s Somatuline Depot (Lanreotide) Injection For The Treatment Of Carcinoid Syndrome 9/18/2017
Medtronic (MDT) Wins FDA Nod and Launch of Next Generation Chronic Pain Spinal Cord Stimulator 9/18/2017
Guerbet (GBT) Announces CE Mark For Vectorio, An Innovative Medical Device For cTACE Procedures 9/14/2017
Summit Biosciences Receives EU Approval For Commercial Manufacturing Of Prescription Nasal Sprays 9/14/2017
Medtronic (MDT) Announces New StealthStation Technology For Ear, Nose, And Throat Procedures 9/12/2017
Medtronic (MDT) Announces Japanese Regulatory Approval For The IN.PACT Admiral Drug-Coated Balloon 9/8/2017
Innovus Pharma Receives Approval From Health Canada For Its Urivarx Product For The Indication To Reduce Symptoms Of Overactive Bladder Such As Daytime Urinary Frequency, Urgency And Nocturia 9/6/2017
Adherium Snags FDA Clearance for Next Generation Smartinhaler for AstraZeneca PLC (AZN)'s Symbicort Aerosol Inhaler 9/1/2017
Novartis AG (NVS) Waltzes to the Finish Line With First Ever FDA Approval for CAR-T 9/1/2017
Teva (TEVA) Announces FDA Approval Of AUSTEDO (Deutetrabenazine) Tablets For The Treatment Of Tardive Dyskinesia In Adults 8/31/2017
Novo Nordisk A/S (NVO) Release: Health Canada Approves Tresiba, A New Basal Insulin For Type 1 And 2 Diabetes 8/28/2017
Kedrion And Kamada (KMDA) Receive FDA Approval Of KEDRAB For Post-Exposure Prophylaxis Against Rabies Infection 8/25/2017
IMRALDI, Biogen (BIIB)’s Adalimumab Biosimilar Referencing Humira, Is Approved In The European Union 8/25/2017
Samsung Bioepis First To Obtain European Commission (EC) Approval For A Third Anti-TNF-? Biosimilar With Imraldi (Adalimumab) 8/25/2017
The European Commission (EC) Finally Approves Merck KGaA (MKGAF.PK)'s Once-Failed MS Drug Cladribine 8/25/2017
Novartis AG (NVS) Kisqali (Ribociclib) Receives EU Approval As First-Line Treatment For HR+/HER2- Locally Advanced Or Metastatic Breast Cancer In Combination With Any Aromatase Inhibitor 8/24/2017
Astex Pharma (ASTX) Celebrates As Cancer Drug Receives Marketing Approval In Europe 8/24/2017
Malin (MLC.IR) Snags FDA Approval for New Hourglass Peripheral Embolisation Plug 8/22/2017
Amicus (FOLD) Announces Approval For Galafold (Migalastat) For Treatment Of Fabry Disease In Australia 8/16/2017
Oasmia Receives Market Approval For Its Anti-Cancer Drug Doxophos In Russia 8/10/2017
Wockhardt (WOCKHARDT.BO)'s Antibiotic Injection Gets U.S. FDA Approval 8/7/2017
Avacen Medical Gets CE Mark for Increasing Microcirculation and Treating Widespread Fibromyalgia Pain 8/4/2017
Graminex L.L.C. Receives NNHPD Health Canada Approval For Pollenaid And Prostanex 8/1/2017
Cycle Pharma Receives FDA Approval Of Nityr (Nitisinone) Tablets For Treatment Of HT-1 8/1/2017
Otsuka Pharma Release: ABILIFY MAINTENA (Aripiprazole) For Extended-Release Injectable Suspension Approved By U.S. FDA For Maintenance Monotherapy Treatment Of Bipolar I Disorder 7/31/2017
Quantel Medical Snags FDA Approval for Easyret Photocoagulator Laser 7/28/2017
Aspect Imaging Nabbed $150 Million and FDA Clearance of the First Dedicated Neonatal MRI System 7/27/2017
Novo Nordisk A/S (NVO): Victoza Has Been Approved In The EU As The Only GLP-1 With A Label To Include Prevention Of Cardiovascular Events 7/27/2017
Sensus Healthcare (SRTSU) Receives Regulatory Approval To Sell The SRT-100 In China For The Treatment And Prevention Of Keloids 7/26/2017
Viriom Obtains First Market Approval Of Elsulfavirine (Elpida) For Treatment Of HIV-1 Infection In Russia 7/25/2017
GlaxoSmithKline (GSK) Receives FDA Approval For A New Self-Injectable Formulation Of Benlysta (Belimumab) For Systemic Lupus Erythematosus 7/24/2017
SillaJen And Lee's Pharmaceutical Announce Approval By The China CFDA To Commence Phase III Clinical Trial For Oncolytic Immunotherapy, Pexa-Vec, In Liver Cancer 7/21/2017
Vifor Pharma Release: European Commission (EC) Approves Marketing Authorisation For Veltassa 7/21/2017
Masimo (MASI) Grabs CE Marking of Noninvasive RPVi 7/20/2017
Perrigo (PRGO) Announces FDA Final Approval For Its AB Rated Generic Version Of DermOtic Oil, 0.01% Ear Drops 7/19/2017
Recordati: The European Commission (EC) Approves Reagila (Cariprazine) For The Treatment Of Schizophrenia 7/19/2017
Ascentage Pharma Approved To Start China Trial Of Apoptosis Drug 7/19/2017
BioLife Solutions, Inc. (BLFS.OB) CryoStor Cell Freeze Media Embedded In Invossa: First Approved Cell And Gene Therapy For Osteoarthritis 7/14/2017
TissueGene, Inc. Release: Korea Approves The World's First Cell And Gene Therapy For Knee Osteoarthritis 7/12/2017
FDA Clears Oventus' O2Vent W 7/12/2017
FDA Green Lights Medtronic (MDT)'s CoreValve Evolut TAVR In Intermediate Risk Patients 7/11/2017
Clinigen And Cumberland Pharmaceuticals (CPIX) Obtain FDA Approval For Totect In The U.S. 7/10/2017
BeyondSpring Granted Approval To Start China Trials Of Plinabulin 7/10/2017
Solasia Pharma K.K. Announces Approval Of Episil (Oral Liquid) In Japan 7/7/2017
Novartis AG (NVS) Receives Approval In The EU For Cosentyx Label Update, Includes Long Term Superiority Data Versus Stelara In Psoriasis 7/6/2017
Isodiol International Receives Regulatory (ANVISA) Approval For Isoderm For The Treatment Of Epilepsy And Parkinson's 7/6/2017
BioCad’s Rituximab Biosimilar To Receive MA Soon In India 7/5/2017
Ipsen (IPN.PA): Somatuline Autogel 120 Mg Receives Japanese Approval For A New Indication For The Treatment Of Gastro-Entero-Pancreatic Neuroendocrine Tumors 7/5/2017
Eli Lilly (LLY) Release: Japan Ministry of Health, Labor And Welfare (MHLW) Grants Marketing Approval For Olumiant (Baricitinib) For The Treatment Of Rheumatoid Arthritis 7/5/2017
Novartis AG (NVS) Receives EU Approval For First-Line Use Of Zykadia In ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) 6/29/2017
Medtronic (MDT)'s SureTune3 Earns CE Mark for DBS Therapy 6/28/2017
European Commission (EC) Approves Almirall’s Skilarence For Moderate-To-Severe Chronic Plaque Psoriasis 6/28/2017
Swedish Orphan Biovitrum Release: EMA Approves The Potential To Dose Every 14 Days Or Longer In Updated Dosing Regimen For Alprolix 6/27/2017
QS Pharma Receives Approval From EMA For Commercial Manufacture 6/27/2017
BioDelivery (BDSI) Announces Health Canada Approval Of BELBUCA 6/23/2017
Pfizer (PFE) Receives Expanded Health Canada Approval For IBRANCE In HR+, HER2- Metastatic Breast Cancer 6/21/2017
Sonoma Pharma (OCLS) Announces Two Singapore Approvals For Microcyn (Hypochlorous Acid) For The Treatment Of Atopic Dermatitis And Hypertrophic / Keloid Scars 6/20/2017
Horizon Pharma (HZNP) Announces Health Canada Approval Of PROCYSBI (Cysteamine Delayed-Release Capsules) For The Treatment Of Nephropathic Cystinosis 6/19/2017
Novartis AG (NVS) Makes Another Dent Into The Biosimilar Market With Approval Of Rixathon 6/19/2017
Mayne Pharma Announces FDA Approval And Immediate Launch Of Doxycycline Hyclate IR Tablets, First Generic To Acticlate 6/16/2017
Ipsen (IPN.PA) Announces FDA Approval Of Dysport (Abobotulinumtoxina) For The Treatment Of Lower Limb Spasticity In Adults 6/16/2017
FDA Green Lights QIAGEN N.V. (QGEN)'s CMV Testing on Automated QIAsymphony Platform 6/6/2017
OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters 6/6/2017
Novartis AG (NVS) Drug Tasigna Receives EU Approval For Inclusion Of Treatment-Free Remission (TFR) Data In Product Label 6/6/2017
Alkermes (ALKS) Release: FDA Approves Two-Month ARISTADA For Treatment Of Schizophrenia 6/6/2017
OxOnc Announces That Co-Development Partner Has Received Approval In Japan And Taiwan For Crizotinib (Xalkori) As A First-Line Treatment For Patients With ROS1-Positive Non-Small Cell Lung Cancer 6/2/2017
BioMarin (BMRN) Release: European Commission (EC) Approves Brineura (Cerliponase Alfa), The First Treatment For CLN2 Disease, A Form Of Batten Disease And Ultra-Rare Brain Disorder In Children 6/1/2017
Ionis Pharma (IONS) Release: SPINRAZA (Nusinersen) Approved In The European Union 6/1/2017
Augmenix Release: SpaceOAR System Receives Shonin Approval In Japan 5/31/2017
NicOx SA (COX.PA) Receives FDA Approval Of ZERVIATE1 (Cetirizine Ophthalmic Solution) 0.24% 5/31/2017
Sobi Canada (B6E.F) Release: Kineret Approved In Canada For The Treatment Of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) 5/30/2017
Athenex And Its Partner, Guangzhou Xiangxue Pharma, Announced Chinese FDA IND Approval To Begin Clinical Trials Of KX-02 Tablet For Glioblastoma 5/25/2017
Market Just Got More Crowded as Regeneron (REGN), Sanofi (SNY)'s New RA Drug Wins FDA Approval 5/24/2017
Swedish Orphan AB - Elocta Approved In The Kingdom Of Saudi Arabia For The Treatment Of Haemophilia A 5/18/2017
Bristol-Myers Squibb Canada Release: Health Canada Approves OPDIVO (Nivolumab) For The Treatment Of Squamous Cell Carcinoma Of The Head And Neck 5/17/2017
Sweden's BrainCool Enters U.S. Market With FDA 510(k) Clearance for IQool System for Temperature Management 5/17/2017
Medtronic (MDT) First to Receive FDA Clearance for MRI-Safe Pacemaker Devices 5/11/2017
ADImmune Corporation's Quadrivalent Flu Vaccine Approved By TFDA 5/10/2017
European Commission (EC) Approves EUSA Pharma’s Dinutuximab Beta For The Treatment Of Patients With High-Risk Neuroblastoma 5/10/2017
Cipher Pharma (DND.TO) Receives Health Canada Approval Of OZANEX (Ozenoxacin Cream 1%) 5/8/2017
Merck & Co. (MRK) Release: European Commission (EC) Approves KEYTRUDA (Pembrolizumab) For Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma Who Failed Autologous Stem Cell Transplant And Brentuximab Vedotin (BV), Or Who Are Transplant-Ineligible And Have Failed BV 5/5/2017
AstraZeneca PLC (AZN) Hits Milestone With Approval of Potential Bladder Cancer Blockbuster 5/3/2017
Sanofi Genzyme (SNY) Announces Approval Of Cerdelga (Eliglustat Capsules) By Health Canada For Rare Genetic Condition 5/1/2017
FDA Green Lights Medtronic (MDT)'s Resolute Onyx Drug-Eluting Stent, the First Available in 4.5 mm and 5 mm Sizes 5/1/2017
Bristol-Myers Squibb (BMY)'s Oral, Interferon-free HCV Regimen Approved In China 5/1/2017
Takeda (TKPYY)'s $5 Billion Bet on Ariad (ARIA) Pays Off With Accelerated Approval of Lung Cancer Med 5/1/2017
Bristol-Myers Squibb (BMY) Release: China FDA Approves Country’s First All-Oral Regimen For Chronic Hepatitis C, Daklinza (Daclatasvir) In Combination With Sunvepra (Asunaprevir) 4/28/2017
European Commission (EC) Extends Approval For Janssen-Cilag International NV (JNJ)’s DARZALEX (Daratumumab) To Include Multiple Myeloma Patients Who Have Received At Least One Prior Therapy 4/28/2017
Novartis AG (NVS) Receives FDA Approval For Rydapt® In Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) And Three Types Of Systemic Mastocytosis (SM) 4/28/2017
Reapplix ApS Release: New FDA 510(K) Clearance For Expanded System Including Automated Centrifuge 4/27/2017
FDA Green Lights Allergan (AGN)'s Tear-Inducing Eye Device TrueTear 4/26/2017
Samsung Bioepis Obtains First Drug Approval In The United States, As FDA Approves RENFLEXIS (Infliximab-Abda) Across All Eligible Indications 4/24/2017
Hoffmann-La Roche AG Release: Health Canada Approves TECENTRIQ (Atezolizumab) For Patients With Locally Advanced And Metastatic Bladder Cancer 4/18/2017
ALK-Abello A/S Release: ACARIZAX Approved In Europe For Use In Adolescent Patients With House Dust Mite-Induced Allergic Rhinitis 4/17/2017
Indian FDA Approves The First Autologous Dendritic Cell-Based Immuno-Oncology Product, APCEDEN 4/5/2017
Teva (TEVA) Finally Wins FDA Approval for Potential Huntington’s Blockbuster Austedo 4/4/2017
Shire (SHPG) Release: INTUNIV (Guanfacine Hydrochloride Prolonged Release), A Non-Stimulant For The Treatment Of ADHD, Receives Approval In Japan 3/30/2017
AstraZeneca PLC (AZN)'s Tagrisso Approved In China Following Priority Review 3/28/2017
Novo Nordisk Canada Inc. (NVO) Release: New Fast-Acting Mealtime Insulin, Fiasp, Now Approved And Available In Canada For The Treatment Of Diabetes 3/27/2017
Shionogi Release: FDA Approves Symproic (Naldemedine) Once-Daily Tablets C-II For The Treatment Of Opioid-Induced Constipation In Adults With Chronic Non-Cancer Pain 3/24/2017
Amgen (AMGN) Release: European Commission (EC) Approves Amgevita (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases 3/24/2017
Why Newron Pharma (NWRN)'s Newly Approved Parkinson's Drug Isn't All That Novel 3/23/2017
Medicure (MCU) Announces FDA Approval For Apicore LLC's Generic Tetrabenazine 3/23/2017
FDA Green Lights Medtronic (MDT)'s CoreValve Evolut Pro Transcatheter Valve With Advanced Sealing 3/22/2017
NovoCure Receives MHLW Approval For Second Generation Optune In Japan 3/20/2017
Surefire Receives Regulatory Approval For Infusion Systems And Guiding Catheters In Mexico 3/20/2017
Pfizer (PFE) Announces Approval By The China Food And Drug Administration Of XELJANZ, The First Oral JAK Inhibitor For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis 3/16/2017
Shire (SHPG) Receives European Approval For Label Extension Of CINRYZE (C1 Inhibitor [Human]) To Prevent And Treat Hereditary Angioedema (HAE) Attacks In Paediatric Patients With HAE 3/16/2017
Cambridge-based Astex Pharma (ASTX) Celebrates As Cancer Drug Receives US Marketing Approval 3/14/2017
Medtronic (MDT) Snags FDA Approval for First of Its Kind Melody Transcatheter Pulmonary Valve 3/14/2017
FDA OKs Medtronic (MDT)'s New Kyphon Xpede Bone Cement 3/14/2017
Ipsen (IPN.PA) Announces Health Canada Approval Of DYSPORT THERAPEUTIC (Abobotulinumtoxina) For The Treatment Of Patients With Cervical Dystonia And Adult Upper Limb Spasticity 3/14/2017
Pfizer (PFE) Looks Over Its Shoulder as Novartis AG (NVS) Grabs a Quick Approval for Breast Cancer Drug 3/14/2017
Ipsen (IPN.PA) Announces MHRA1 Approval Of New Indication For Decapeptyl For The Treatment Of Pre-Menopausal Women With Early Stage Breast Cancer 3/13/2017
Medtronic (MDT) Nabs FDA Nod for Reveal LINQ Insertable Cardiac Monitor With TruRhythm Detection 3/13/2017
Clinigen Release: First-In-Class Fycompa (Perampanel) Approved In South Africa For Partial-Onset Seizures 3/10/2017
Swedish Orphan AB - FDA Approves In-Use Storage At Room Temperature For Orfadin Capsules 3/7/2017
BioCad: The First Ever Biosimilar Of Interferon Beta-1a Approved In Russia 3/6/2017
Sobi Receives Approval From The EMA For Higher Capacity Drug Substance Manufacturing For Elocta 3/2/2017
Perrigo (PRGO) Announces FDA Final Approval For The Generic Version Of Axiron Topical Solution, 30 mg/1.5 mL 3/1/2017
Chugai Pharma's ALK Inhibitor "Alecensa" Approved In Taiwan 2/27/2017
BTG plc (BTG.L) Snags FDA Clearance for Blood Clot Device EKOS Control Unit 4.0 2/27/2017
OWC Pharmaceutical Research Corp. Receives IRB Approval To Initiate Safety Testing On Its Cannabinoid-Infused Cream For Treatment Of Psoriasis 2/27/2017
Celgene (CELG) Release: REVLIMID (Lenalidomide) Approved By European Commission (EC) As Monotherapy For The Maintenance Treatment Of Patients With Newly Diagnosed Multiple Myeloma After Autologous Stem Cell Transplantation 2/24/2017
Amgen (AMGN) Wins European Commission (EC) Approval for Repatha Single-Dose Delivery Option 2/23/2017
Celltrion Healthcare (068270.KQ) Release: Truxima, The First Biosimilar Mab In Oncology, Granted EU Marketing Authorization 2/22/2017
Chugai Pharma’s ALK Inhibitor "Alecensa" Approved In The EU 2/21/2017
Royal Philips Electronics N.V. (PHG) Snags FDA Approval for Inpatient Continuous Monitoring System 2/21/2017
Health Canada Approves Otsuka Pharma And Lundbeck (LUN.CO)'s REXULTI (Brexpiprazole) As A Treatment For Schizophrenia In Adults 2/20/2017
FDA Clears Expanded Indication for Medtronic (MDT)'s Freezor Xtra Cryoablation Catheter 2/17/2017
Boehringer Ingelheim Release: FDA Expands Approval Of Tiotropium Respimat For Maintenance Treatment Of Asthma In Children 2/16/2017
The FDA Has Approved Tirosint-SOL, Levothyroxine In Liquid Solution For The American Market, IBSA Patent 2/15/2017
Eli Lilly (LLY) Release: European Commission (EC) Approves Once-Daily Olumiant Tablets For Treatment Of Adults With Moderate-To-Severe Active Rheumatoid Arthritis 2/14/2017
Japanese Regulators Approve AmoyDx’s ROS1 Fusion CDx For Lung Cancer Drug 2/3/2017
Sobi Obtains Approval From The European Commission (EC) For New Dosing Frequency Of Orfadin 2/2/2017
Regeneron (REGN) And Sanofi (SNY) Announce First Approval Of Kevzara (Sarilumab) For The Treatment Of Moderately To Severely Active Rheumatoid Arthritis In Adult Patients By Health Canada 2/1/2017
Merck & Co. (MRK) Release: European Commission (EC) Approves KEYTRUDA (Pembrolizumab) For First-Line Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression With No EGFR Or ALK Positive Tumor Mutations 2/1/2017
Endo International (ENDP) Announces U.S. FDA Approval Of Ephedrine Sulfate Injection, USP 1/31/2017
Teva (TEVA) Announces FDA Approval Of Two New RespiClick Maintenance Inhalers For The Treatment Of Asthma 1/30/2017
Recordati Announces Marketing Approval For Cystadrops 1/27/2017
Boehringer Ingelheim Release: Jardiance (Empagliflozin) Becomes First Type 2 Diabetes Medicine In The EU To Include Cardiovascular Death Reduction Data In Label 1/26/2017
Allergan (AGN) Release: FDA Approves 72 Mcg Dose Of LINZESS (Linaclotide) For Adults With Chronic Idiopathic Constipation 1/26/2017
Adapt Pharma Release: NARCAN (Naloxone Hcl) Nasal Spray 2mg Approved By FDA 1/25/2017
Implanet Release: Medtech Announces Global Marketing Clearance of the New JAZZ FRAME 1/25/2017
Celgene (CELG) Release: Health Canada Approves REVLIMID Plus Dexamethasone As A First-Line Treatment For Patients Newly Diagnosed With Multiple Myeloma, Not Eligible For Transplant 1/24/2017
Zealand Pharma  (ZEAL.CO) Release: EU Approval Of Suliqua Triggers $10 Million Milestone Payment To Company 1/18/2017
Teva (TEVA) Release: Company Receives FDA Approval For VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated With Proprietary Abuse Deterrence Technology 1/18/2017
SpineGuard Release: Medical Device Receives FDA Clearance to Market Its DSG Integration Module for Making Pedicle Screws “Smart” 1/16/2017
Duchesnay Release: Company Is Pleased To Announce That Health Canada Has Granted Market Authorization For Mictoryl/Mictoryl Pediatric 1/10/2017
Servier Canada Release: Health Canada Approves New Heart Failure Treatment LANCORA To Reduce Mortality And Hospitalizations 1/10/2017
CSL Behring Release: AFSTYLA, For Haemophilia A, Receives European Commission Approval 1/9/2017
Debiopharm's Triptorelin 6-Month Formulation Receives Approval For The Treatment Of Central Precocious Puberty (CPP) In Europe 1/9/2017
FDA Approval of Aurobindo (AUROPHARMA.BO)'s Two Drugs Sends Stock Up 1/3/2017
NuVasive (NUVA) To Resume XLIF Procedures In Japan In First Quarter 2017 12/29/2016
NanoVibronix Receives Health Canada Approval to Sell WoundShield in Canada 12/28/2016
BioNet Received Thai FDA Approval of the World's Only Available Recombinant Monovalent Acellular Pertussis (aP) Vaccine 12/27/2016
Eisai Company (ESALY.PK) Release: Anticancer Agent Treakisym Approved In Japan For Additional Indication As First-Line Treatment For Low-Grade B-Cell Non-Hodgkin's Lymphoma And Mantle Cell Lymphoma 12/22/2016
Pfizer (PFE) Receives Approval In The European Union For Nimenrix (Meningococcal Group A, C, W-135, And Y Conjugate Vaccine) In Infants Six Weeks Of Age And Older 12/19/2016
Merck & Co. (MRK) Release: KEYTRUDA (Pembrolizumab) Approved As First Anti-PD-1 Therapy In Japan For First-Line Treatment Of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express High Levels Of PD-L1 12/19/2016
Ironwood (IRWD) Announces Approval Of LINZESS (Linaclotide) In Japan For The Treatment Of Adults With IBS-C 12/19/2016
Eisai Inc. (ESALF.PK) And Arena (ARNA) Announce Regulatory Approval Of BELVIQ (Lorcaserin Hcl) In Brazil 12/19/2016
Health Canada Approves CSL Behring's AFSTYLA For The Treatment Of Hemophilia A 12/15/2016
Janssen Release: Health Canada Approves STELARA For The Treatment Of Adults With Moderately To Severely Active Crohn's Disease 12/14/2016
Ferring Pharma Receives EU Approval For REKOVELLE (Follitropin Delta) 12/13/2016
Biogen (BIIB) And AbbVie (ABBV) Receive Health Canada Approval Of Once-Monthly ZINBRYTA (Daclizumab Beta) For Multiple Sclerosis 12/9/2016
Mederi Therapeutics Inc.'s Stretta Therapy For GERD Approved In China 12/8/2016
Boehringer Ingelheim Release: FDA Approves Jardiance (Empagliflozin) Tablets To Reduce The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes And Established Cardiovascular Disease 12/6/2016
GlaxoSmithKline (GSK) Release: Relvar Ellipta 100/25 mcg Gains Approval In Japan For Use In Patients With COPD 12/2/2016
Helsinn Integrative Care Wins FDA Nod for Medical Device Xonrid Gel 12/1/2016
Corsens Medical Announces Clearance of a 510(K) Pre-Marketing Notification With The FDA for the Corsens Cardiac Monitor 11/28/2016
Zealand Pharma  (ZEAL.CO) Release: The U.S. FDA Approves Soliqua 100/33 For The Treatment Of Adults With Type 2 Diabetes 11/22/2016
Genmab A/S (GEN.CO) Announces U.S. FDA Approval Of DARZALEX (Daratumumab) For Relapsed Multiple Myeloma And Updates Financial Guidance 11/22/2016
Allergan (AGN) Release: FIBRISTAL, The First And Only Medication Indicated For Uterine Fibroids, Receives Approval From Health Canada For Long Term Intermittent Treatment 11/21/2016
Teva (TEVA) Secures European Approval Of Trisenox For First Line Treatment Of Low To Intermediate Risk Acute Promyelocytic Leukemia (APL) 11/21/2016
Swedish Orphan Biovitrum: Elocta Approved in Kuwait For The Treatment Of Hemophilia A 11/21/2016
Medtronic (MDT)'s Solitaire Stent Retriever Device Wins Expanded Nod From the FDA 11/16/2016
LimFlow Receives CE Mark For Purely Percutaneous Critical Limb Ischemia (CLI) Technology Designed To Restore Perfusion For “No Option” Patients 11/15/2016
Amgen (AMGN) Release: European Commission (EC) Approves Parsabiv (etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adults On Hemodialysis 11/14/2016
Janssen-Cilag International NV (JNJ) Release: European Commission (EC) Approves STELARA (Ustekinumab) For Treatment Of Adults With Moderately To Severely Active Crohn’s Disease 11/11/2016
FDA Clearance For jioima Vaporflex And Legato Electrosurgical Probes 11/9/2016
Mallinckrodt (MNK) Announces U.S. FDA Approval Of OFIRMEV IV Bag Presentation 11/9/2016
FDA Green Lights Propeller Health's Sensor for GlaxoSmithKline (GSK) Ellipta Inhaler 11/7/2016
Teva (TEVA) Announces Approval Of Generic Tribenzor In The United States 11/7/2016
Advanced Accelerator Applications Announces Swiss Marketing Authorization For Two PET Diagnostic Products 11/2/2016
Bristol-Myers Squibb Canada (BMY) Release: First-Ever Combination Of Two Immuno-Oncology Agents For Metastatic Melanoma Approved By Health Canada 11/1/2016
Swedish Orphan Biovitrum: Alprolix Approved In Switzerland For The Treatment Of Hemophilia B 10/28/2016
Apricus Biosciences (APRI) Announces Approval Of Vitaros For The Treatment Of Erectile Dysfunction In Greece 10/26/2016
Medtronic (MDT) Nabs FDA Clearance for New Lower Profile HawkOne 6F Directional Atherectomy System 10/25/2016
Martindale Pharma Release: Clobazam Oral Suspension Approved In Seven European Countries 10/25/2016
Martindale Pharma Release: Clobazam Oral Suspension Approved In Seven European Countries 10/24/2016
Tillotts Pharma AG's Parent Company Zeria Pharmaceutical Co., Ltd. Receives Approval For Zentacort 3mg Capsules In Japan 10/6/2016



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