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Clinical - Approvals (World)
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
Orexo (ORXOF): FDA Approves Unique Low Dosage Of Zubsolv 10/6/2016
Second Teligent Topical Product Approved By Health Canada 10/5/2016
Health Canada Approves Adapt Pharma's Naloxone Hydrochloride Nasal Spray To Treat Opioid Overdose 10/4/2016
PaizaBio Receives CFDA Approval To Expand Fill-and-Finish Contract Manufacturing Operation China 10/3/2016
Health Canada Approves First Teligent Topical Product 9/30/2016
Medtronic (MDT) Nabs FDA Nod for World's First Artificial Pancreas for Diabetes 9/29/2016
Medtronic (MDT) Snags FDA Nod for TrailBlazer Angled Peripheral Support Catheter 9/28/2016
AbbVie (ABBV) And Eisai Company (ESALY.PK) Obtain Additional Approval For New Indication Of Fully Human Anti-TNF-Alpha Monoclonal Antibody HUMIRA In The Treatment Of Non-Infectious Uveitis 9/28/2016
Ariad (ARIA) Announces Regulatory Approval For Iclusig (Ponatinib) In Japan 9/28/2016
Easton Pharmaceuticals (OP: EAPH) Announces Receiving Mexican Regulatory Approval For Vagisan (VS-Sense) Diagnostic Device, In Support Of On-Going Exclusive Distribution Negotiations With Multi-National Pharmaceutical Companies For Major Latin American Markets 9/27/2016
FDA Clears Global Kinetics's Parkinson’s Kinetigraph, A Wrist-Worn Device for 24/7 Monitoring of Parkinson’s Disease Patients 9/22/2016
Heidelberg Engineering Receives FDA Clearance To Market SPECTRALIS OCT Glaucoma Module Premium Edition 9/21/2016
Medeon Biodesign Wins FDA OK for Abclose - Laparoscopic Port Site Closure Device 9/19/2016
FDA Green Lights Bayer (BAY)'s Five-Year Contraceptive Kyleena 9/19/2016
Aralez Announces FDA Approval Of YOSPRALA For Secondary Prevention Of Cardiovascular And Cerebrovascular Events In Patients At Risk For Aspirin-Associated Gastric Ulcers 9/15/2016
FDA Clears Medtronic (MDT)'s First Drug-Coated Balloon for In-Stent Restenosis (ISR) 9/14/2016
European Commission (EC) Approves Ipsen (IPN.PA)’s Cabometyx (Cabozantinib) Tablets For The Treatment Of Advanced Renal Cell Carcinoma (RCC) In Adults Following Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Therapy 9/14/2016
Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar To Receive Regulatory Approval In Canada 9/12/2016
Crescita Therapeutics Announces Approval Of Pliaglis In Mexico 9/9/2016
FDA Green Lights Medtronic (MDT)'s Enlite Continuous Glucose Sensor 9/1/2016
Amgen (AMGN) Cringes as FDA Approves Novartis AG (NVS)'s Anti-Inflammatory Drug Erelzi 8/31/2016
Eisai Company (ESALY.PK) Release: Anticancer Agent "Treakisym For Injection 100 Mg" Approved In Japan For Additional Indication Of Chronic Lymphocytic Leukemia 8/26/2016
Teligent Announces Health Canada Approval Of Three Baclofen Injection Products 8/25/2016
BTG plc (BTG.L) Receives Health Canada Approval For DC Bead LUMI 8/25/2016
Teligent Announces Health Canada Approval Of Gentamicin Injection USP 8/23/2016
Masimo (MASI) Announces CE Marking For RAS-45 Sensor For Rainbow Acoustic Monitoring Of Respiration Rate 8/18/2016
Cardiome Pharma Corp. (COM.TO) Announces XYDALBA Single Dose Infusion Approval By EMA 8/10/2016
Medtronic (MDT) Nabs CE Mark for Deep Brain Stimulation Therapy Software 8/10/2016
Takeda (TKPYY) Receives Marketing Authorization In Canada For NINLARO (Ixazomib) In Relapsed/Refractory Multiple Myeloma 8/8/2016
Masimo (MASI) Wins CE Marking for Pediatric O3 Regional Oximetry 8/4/2016
ITM's Subsidiary ITG Receives Drug Approval For EndolucinBeta 8/4/2016
Ipsen (IPN.PA) Announces FDA Approval Of Dysport (Abobotulinumtoxina) For Injection For The Treatment Of Lower Limb Spasticity In Children Aged Two And Older 8/1/2016
With Hopes of Bolstering Sanofi (SNY)’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S. 7/28/2016
Valeant (VRX), Progenics (PGNX) Shares Climb on Constipation Drug Approval 7/20/2016
Janssen Release: Health Canada Approves INVOKAMET For The Treatment Of Adults With Type 2 Diabetes 7/20/2016
Medtronic (MDT) Receives First-Ever FDA Clearance For Cement-Augmented Pedicle Screws 7/20/2016
GlaxoSmithKline (GSK)'s Cervarix Is First HPV Vaccine Approved For China Use 7/20/2016
Medtronic (MDT) Nabs CE Mark Approval for Its Continuous Glucose Monitoring (CGM) System 7/19/2016
Celgene (CELG) Release: REVLIMID (Lenalidomide) Approved By The European Commission (EC) For The Treatment Of Relapsed/Refractory Patients With Mantle Cell Lymphoma 7/15/2016
Eisai Inc. (ESALF.PK) And Arena (ARNA) Announce Regulatory Approval Of VENESPRI (Lorcaserin Hcl) In Mexico 7/14/2016
Gilead (GILD) Receives Approval In Canada For EPCLUSA (Sofosbuvir/Velpatasvir), The First Once-Daily Pan-Genotypic (Genotypes 1-6) Single Tablet Regimen For The Treatment Of Chronic Hepatitis C 7/14/2016
Swedish Orphan Biovitrum: Health Canada Validates Orfadin Capsule Filing 7/14/2016
Medtronic (MDT) Gets FDA Nod for IN.PACT Admiral DCB 150 mm Lengths 7/13/2016
Shire (SHPG) Soars After the FDA Approves Long-Awaited Dry-Eye Disease Drug 7/12/2016
AstraZeneca Canada (AZN) Release: TAGRISSO (Osimertinib) Approved Health Canada As Treatment For Patients With Locally Advanced Or Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer 7/11/2016
AOP Orphan Pharmaceuticals AG Announces European "Approvable" Opinion Of Its Ultra-Short Acting Beta Blocker Rapibloc (Landiolol) 7/11/2016
Takeda (TKPYY) Receives European Commission (EC) Approval Of ADCETRIS (Brentuximab Vedotin) For Consolidation Treatment In Post-Transplant Hodgkin Lymphoma 7/6/2016
Regeneron (REGN) And Sanofi (SNY) Announce Approval Of Praluent (Alirocumab) For The Treatment Of Hypercholesterolemia In Japan 7/5/2016
Juniper Pharma (JNP) Announces That Merck KGaA (MKGAF.PK), Darmstadt, Germany, Has Obtained Regulatory Approval For OneCrinone In Japan 7/5/2016
Bial Release: European Commission (EC) Approves ONGENTYS (Opicapone) – A Novel Treatment For Parkinson's Disease Patients With Motor Fluctuations 7/5/2016
European Commission (EC) Approves Extended Indication For Amgen (AMGN)'s Kyprolis (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma Patients 7/5/2016
Galderma Pharma S.A. Announces Approval Of Epiduo Gel For The Treatment Of Acne In Japan 7/5/2016
Health Canada Issued Notice of Compliance With Conditions Approving Janssen's Darzalex 6/30/2016
Janssen Biologics B.V. Release: SIMPONI Receives European Commission Approval For Treatment Of Polyarticular Juvenile Idiopathic Arthritis 6/30/2016
AstraZeneca PLC (AZN) Gets EU Approval For Zavicefta Antibiotic Treatment 6/28/2016
Health Canada Approves Janssen's Invega Trinza for Schizophrenia 6/27/2016
New Four-Strain Influenza Vaccine, VaxigripTetra, Regulatory Dossier From Sanofi Pasteur (SASY.PA) Now Approved In Europe 6/23/2016
Eli Lilly Canada Inc. (LLY) Release: Health Canada's Approval Of Taltz (Ixekizumab) Brings Targeted Therapy To Canadians Living With Moderate-To-Severe Plaque Psoriasis 6/21/2016
FDA Approves PaxVax, Inc. To Manufacture Vaxchora (Oral Cholera Vaccine) At SynCo Bio Partners B.V. 6/20/2016
AbbVie (ABBV), Eisai Company (ESALY.PK), And EA Pharma Obtain Additional Approval For New Dosing Regimen Of Fully Human Anti-TNF Monoclonal Antibody Humira In Patients With Crohn's Disease 6/20/2016
SpineGuard Wins FDA Clearance to Market PediGuard Threaded DSG Device 6/17/2016
Protagen AG Announces CE Mark For Its Proprietary Multilisa® BICD2 Test For Better Diagnosis Of Systemic Sclerosis 6/15/2016
Swedish Orphan Biovitrum: Orfadin 20 Mg Capsule Approved In The U.S. 6/15/2016
Shire (SHPG) And Kamada Ltd. (KMDA) Announce FDA Approval Of Expanded Label For Self-Infusion Of GLASSIA For The Treatment Of Emphysema Due To Severe AAT Deficiency 6/15/2016
TaiGen Biotechnology Receives Market Approval From The China Food And Drug Administration For Taigexyn (Nemonoxacin) 6/14/2016
ViiV Healthcare Announces FDA Approval To Lower The Weight Limit For Dolutegravir In Children And Adolescents Living With HIV 6/10/2016
Stentys Announces CE Marking Of Its Longest Xposition Stent 6/8/2016
Merz Aesthetics (Formerly Known as BioForm Medical, Inc.) Receives CE Mark For Radiesse (+) Lidocaine 6/7/2016
Allergan (AGN) Announces FDA Approval Of BYVALSON (Nebivolol And Valsartan) 6/6/2016
Advanced Accelerator Applications Applications Announces FDA Approval of NETSPOT (Somakit-TATE), a Kit for the Preparation of Gallium Ga 68 Dotatate for Neuroendocrine Tumor Detection 6/2/2016
Allergan (AGN) Release: JUVÉDERM VOLBELLA XC Approved By U.S. FDA For Use In Lips And Perioral Rhytids 6/1/2016
AbbVie (ABBV) Release: European Commission (EC) Approves IMBRUVICA (Ibrutinib) For First-Line Treatment Of Patients With Chronic Lymphocytic Leukemia 5/31/2016
Stempeutics Release: DCGI Gives Limited Approval To Market FIRST Allogeneic Cell Therapy Product In India Stempeutics Puts India On The 'World Map Of Regenerative Medicine' 5/31/2016
Merck & Co. (MRK) Release: New Cancer Immunotherapy Indication For Canadian Patients With Untreated Metastatic Melanoma 5/31/2016
Micreos Release: FSANZ Approves Salmonelex As Processing Aid Against Salmonella 5/31/2016
Samsung Bioepis Becomes First To Obtain European Commission Approval For Second Anti-TNF-? Biosimilar With Flixabi 5/31/2016
Janssen-Cilag International NV (JNJ) Release: European Commission (EC) Approves TREVICTA (Paliperidone Palmitate A 3-Monthly Injection), For Maintenance Treatment Of Schizophrenia 5/31/2016
DCGI Gives Limited Approval To Market First Allogeneic Cell Therapy Product In India 5/30/2016
Ortho Kinematics Secures Health Canada Approval 5/26/2016
Sanofi (SNY) Snags FDA Panel's Support for New Once-Daily Diabetes Combo iGlarLixi 5/26/2016
Bristol-Myers Squibb Canada (BMY) Release: Health Canada Approves DAKLINZA (Daclatasvir) For Difficult-To-Treat Hepatitis C Patient Populations 5/24/2016
Janssen-Cilag International NV (JNJ)’s Single-Agent DARZALEX (daratumumab) Approved By European Commission For Treatment OIf Multiple Myeloma (MM) 5/23/2016
Teijin Pharma’s FEBURIC (Febuxostat) Approved As Indication For Cancer Chemotherapy-Induced Hyperuricemia 5/23/2016
Swedish Orphan Biovitrum: Alprolix (rFIXFc) Approved In The EU For The Treatment Of Hemophilia B 5/13/2016
Bristol-Myers Squibb (BMY) And AbbVie (ABBV) Announce European Commission Approval Of Empliciti (Elotuzumab) For The Treatment Of Multiple Myeloma In Adult Patients Who Have Received At Least One Prior Therapy 5/12/2016
Martindale Pharma Release: Prenoxad Injection Approved In Five European Countries Opening Way For Pan-European Availability Of A Take-Home Naloxone Product 5/11/2016
European Commission (EC) Approves IDELVION --CSL Behring's Novel Hemophilia B Treatment With Up To 14-Day Dosing Intervals 5/11/2016
Pfizer Canada Release: Health Canada Approves New First-Line Treatment For Women Living With Metastatic Breast Cancer 5/10/2016
AstraZeneca Canada (AZN) Release: Health Canada Approves LYNPARZA For The Treatment Of Ovarian Cancer In Patients With BRCA-Mutations 5/3/2016
Ferring Pharma Announces Approval For NOCDURNA, A New Therapeutic Option For The Treatment Of Adults Waking Multiple Times To Urinate At Night 5/3/2016
TGA Australia Approval Opens Up Australian Markets For Amanta Healthcare 5/3/2016
Orexigen (OREX) Announces South Korean Approval Of Contrave (Naltrexone HCI And Bupropion HCI Extended-Release) Monotherapy For Weight Management In Overweight Or Obese Adult Patients 5/2/2016
FDA Green Lights Medtronic (MDT)'s Afib-Detecting Visia ICD 5/2/2016
Teva (TEVA) Announces FDA Approval Of Proair Respiclick (Albuterol Sulfate) Inhalation Powder For Pediatric Asthma Patients Ages 4 To 11 4/29/2016
Taiho Pharma Release: Patients With Advanced Metastatic Colorectal Cancer In Europe Now Have New Treatment Option As LONSURF (Trifluridine/Tipiracil) Receives EU Approval 4/28/2016
Swedish Orphan Biovitrum Release: Orfadin Oral Suspension Approved In The U.S. 4/26/2016
Aralez Receives Health Canada Approval For Blexten 4/25/2016
Fractyl Snags CE Mark Approval for Revita DMR 4/15/2016
Eisai Company (ESALY.PK) Release: Aricept Approved In The Philippines For New Indication As Treatment For Dementia With Lewy Bodies 4/14/2016
Genentech (RHHBY) Announces FDA Grants Venclexta (Venetoclax) Accelerated Approval For People With A Hard-To-Treat Type Of Chronic Lymphocytic Leukemia 4/12/2016
Synthon Pharmaceuticals Obtains Approval For Glatiramer Acetate 20 mg/mL In Europe 4/12/2016
Medtronic (MDT)'s Tiny Wireless Pacemaker Wins FDA Approval 4/7/2016
Cipher Pharma (DND.TO) Announces Approvals Of Astion Acquired Barrier Creams By Health Canada And The Medicines Evaluation Board 4/7/2016
FDAAdvisoryCommittee.com Approves Celltrion (068270.KQ)’s INFLECTRA, the First Cheaper Version of Johnson & Johnson (JNJ) Blockbuster Remicade 4/7/2016
Pfizer (PFE) Receives European Approval For New Multi-Dose Vial Presentation Of Prevenar 13 4/6/2016
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab) For Previously Treated Advanced Renal Cell Carcinoma 4/6/2016
European Commission (EC) Approves Expanded Use Of Bristol-Myers Squibb (BMY)'s Opdivo (Nivolumab) To Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer 4/6/2016
Baxalta (BXLT) Expands Global Reach Of ADYNOVATE For Hemophilia A Patients With Approval In Japan 4/4/2016
Medtronic (MDT) Snags Expanded Indication for Pillcam Colon 2 3/31/2016
Jazz Pharma (JAZZ) Finally Bags FDA Approval for Rare Liver Disorder Drug Defitelio 3/31/2016
Bio Products Laboratory Receives European Approval For Coagadex (Human Coagulation Factor X) 3/30/2016
Alexion (ALXN) Release: Kanuma (Sebelipase Alfa) Receives Marketing Approval In Japan For Treatment Of Patients With Lysosomal Acid Lipase Deficiency (LAL-D) 3/28/2016
Teva (TEVA) Announces FDA Approval Of CINQAIR (Reslizumab) Injection 3/23/2016
LEO Pharma Receives Scientific Approval Of Enstilar For The Treatment Of Psoriasis In EU 3/21/2016
Horizon Pharma (HZNP) Receives Health Canada Approval For RAVICTI (Glycerol Phenylbutyrate) Oral Liquid For The Treatment Of Urea Cycle Disorders In Patients Two Years Of Age And Older 3/21/2016
Olea Medical Receives FDA Clearance For Olea Sphere 3.0 3/21/2016
Merz Pharma Group Announces European Approval Of Bocouture For The Treatment Of Upper Facial Lines 3/17/2016
FDA Gives Thumbs Up to Bayer (BAY)'s Hemophilia A Drug Kovaltry 3/17/2016
Vertex (VRTX) Receives Australian Approval For ORKAMBI (Lumacaftor/Ivacaftor), The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis In People Ages 12 And Older With Two Copies Of The F508del Mutation 3/9/2016
Reapplix Snags FDA Approval for Its 3C Patch System 3/1/2016
Bristol-Myers Squibb Canada (BMY) Release: Health Canada Approves OPDIVO (nivolumab) For The Treatment Of Advanced Or Metastatic Non-Small Cell Lung Cancer 3/1/2016
EOS Imaging Receives CE Mark For Spineeos Online 3D Surgical Planning Solution For The EOS System 2/29/2016
Allergan (AGN) Announces FDA Approval Of ACZONE (dapsone) Gel, 7.5% For Treatment Of Acne Vulgaris 2/26/2016
Roche Canada Release: New Targeted Therapy For Treatment Of Serious Form Of Skin Cancer Approved In Canada 2/25/2016
U.S. FDA Approves UCB Group (UCBJF.PK)'s New Epilepsy Treatment, BRIVIACT, For Patients With Partial-Onset Seizures 2/22/2016
ScandiDos Wins FDA Approval for Delta4 Discover in U.S. 2/19/2016
FDA Approves Medtronic (MDT)'s DBS Therapy for Parkinson's Patients 2/17/2016
Promius Pharma, LLC Receives FDA Approval For Sernivo (Betamethasone Dipropionate) Spray, 0.05% 2/8/2016
Dr. Reddy's Laboratories Ltd. (RDY) Receives FDA Approval For ZEMBRACE Symtouch (sumatriptan succinate) Injection For The Acute Treatment Of Migraines In Adults 2/3/2016
Bayer (BAY) Release: Health Canada Approves New Treatment Option For Canadian Adults and Children Living with Hemophilia A 2/3/2016
Servier Canada Inc. Release: Viacoram Now Approved In Canada As A New First Line Treatment In Hypertension 1/29/2016
Dr. Reddy's Laboratories Ltd. (RDY) Receives FDA Approval For ZEMBRACE Symtouch (Sumatriptan Succinate) Injection For The Acute Treatment Of Migraines In Adults 1/29/2016
European Commission Approves Daklinza (Daclatasvir) For The Treatment Of Genotype 1, 3 And 4 Chronic Hepatitis C Patients With HIV Coinfection, Advanced Cirrhosis And Post-Liver Transplant Recurrence Of HCV 1/29/2016
Health Canada Approves Amgen (AMGN)'s New Multiple Myeloma Treatment Kyprolis (carfilzomib) 1/28/2016
Vertex (VRTX) Release: Health Canada Approves PrORKAMBI (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 1/27/2016
Amgen (AMGN)'s Repatha (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol 1/22/2016
LifeWatch Corp Granted FDA Approval for its Mobile Cardiac Telemetry 1-Lead Patch 1/18/2016
Biogen (BIIB) Release: BENEPALI,The First Etanercept Biosimilar Referencing Enbrel, Approved In The European Union 1/18/2016
Medtronic (MDT) Wins FDA Approval for OsteoCool RF Ablation System 1/13/2016
Janssen Inc. Release: Health Canada Approves Stelara As First Biologic In North America For The Treatment Of Moderate-To-Severe Psoriasis In Adolescents 1/13/2016
Health Canada Approves Amgen (AMGN)'s BLINCYTO (blinatumomab) For The Treatment Of Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia 1/12/2016
Vivasure Medical Receives CE Mark For First And Only Fully Bioabsorbable Percutaneous Closure Device For Large-Bore Transcatheter Procedures 1/8/2016
AbbVie (ABBV)'s HUMIRA (Adalimumab) Receives First And Only Health Canada Approval For Moderate To Severe Hidradenitis Suppurativa 1/6/2016
FDA Greenlights AstraZeneca PLC (AZN)'s Gout Drug Zurampic 12/23/2015
Actelion (ALIOF.PK)'s Uptravi Received FDA Approval, to Enter U.S. Market in January 12/23/2015
Sanofi Pasteur (SASY.PA)'s Dengue Vaccine Approved in the Philippines 12/22/2015
BiondVax Pharmaceuticals Approval For A Patent For Its Universal Flu Vaccine In Israel 12/21/2015
Baxalta (BXLT) Release: Technology Transfer Success At The MDC: U.S. Approval For New Bleeding Disorder Drug 12/21/2015
Celgene (CELG) Release: Oral REVLIMID Plus Dexamethasone Granted Approval For Treatment Of Patients With Newly Diagnosed Multiple Myeloma In Japan 12/21/2015
European Commission (EC) Approves Amgen (AMGN)'s IMLYGIC (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe 12/18/2015
Tris Pharma, Inc. Announces First Ever FDA-Approved Extended-Release Chewable Tablet 12/16/2015
Celsion (CLSN) Receives CFDA Approval To Conduct The OPTIMA Study In China 12/16/2015
Swissmedic Approves Akynzeo (netupitant/palonosetron) For Use In The Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV) In Switzerland 12/15/2015
BTG plc (BTG.L) Wins FDA Approval for LC Bead LUMI, the First Commercially Available Radiopaque Embolic Bead in the U.S. 12/14/2015
Chugai Pharmaceutical Co., Ltd. (Japan)'s ALK Inhibitor "Alecensa" Accelerated Approval In Three Months After Priority Review Designation In The US 12/14/2015
EDAP TMS (EDAP) Receives Russian Regulatory Approval For Focal One HIFU Device 12/11/2015
Sanofi Pasteur (SASY.PA) to Launch World's First Dengue Vaccine in Mexico 12/10/2015
Medtronic (MDT) Wins Approval for the Only Full-Body MR Conditional DBS 12/9/2015
Cipher Pharma (DND.TO) Receives Health Canada Approval Of (Pr)Beteflam 12/7/2015
Samsung Bioepis' RENFLEXIS Infliximab Biosimilar Receives Regulatory Approval in Korea 12/4/2015
Eisai And Toyama Chemical Clear All-Case Surveillance Condition For Approval Of Antirheumatic Agent Iguratimod 12/1/2015
Enzymotec's Incog, An Innovative Lipid Composition For Cognitive Functioning, Approved As Novel Food In Europe 12/1/2015
Horizon Pharma (HZNP) Receives European Commission (EC) Approval For RAVICTI (Glycerol Phenylbutyrate) Oral Liquid For The Treatment Of Urea Cycle Disorders In Patients Two Months Of Age And Older 12/1/2015
Boehringer Ingelheim And Eli Lilly Canada Inc. (LLY) Release: Health Canada Approves JARDIANCE (empagliflozin) Tablets For Adults With Type 2 Diabetes 11/30/2015
Boehringer Ingelheim Release: Praxbind (Idarucizumab) Approved In European Union For The Specific Reversal Of Pradaxa (Dabigatran Etexilate) 11/30/2015
XENIOS AG Grabs CE Mark for Its i-cor Synchronized Cardiac Assist System 11/25/2015
Roche (RHHBY) Receives EU Approval Of Cotellic For Use In Combination With Zelboraf In Advanced Melanoma 11/25/2015
Pfizer (PFE) Receives European Approval To Expand Use Of XALKORI(Crizotinib) To First-Line Treatment Of Adults With ALK-Positive Advanced Non-Small Cell Lung Cancer 11/25/2015
Debiopharm's Partner Yakult Honsha Announces Elplat Approbation In Gastric Cancer In Japan 11/24/2015
Swedish Orphan Biovitrum And Biogen (BIIB)’s ELOCTA (rFVIIIFc) Approved In Europe For The Treatment Of Haemophilia A 11/24/2015
FDA Grants Full U.S. Approval for Novartis AG (NVS)' Targeted Skin Cancer Combo 11/23/2015
Amgen (AMGN) Release: European Commission Approves Kyprolis (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma 11/20/2015
FDA Approves Takeda (TKPYY)'s Ixazomib for Multiple Myeloma 11/20/2015
Vertex (VRTX) Receives EU Approval For ORKAMBI (Lumacaftor/Ivacaftor), The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis In People Ages 12 And Older With Two Copies Of The F508del Mutation 11/20/2015
Acerus Reports Approval Of ESTRACE Generic In Canada 11/20/2015



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