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Clinical - Approvals (World)
Athenex And Its Partner, Guangzhou Xiangxue Pharmaceutical, 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
Mitsubishi Tanabe Wins FDA Approval for Radicava, the First New ALS Drug in 22 Years 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
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



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