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Clinical - Approvals (World)
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
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



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