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Clinical - Approvals
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
Oculus Innovative Sciences (OCLS) Wins FDA Nod for New Post-Dermal-Procedures Product for Removal of Foreign Material Including Microorganisms 8/24/2016
Teligent Announces Health Canada Approval Of Gentamicin Injection USP 8/23/2016
ImPACT Is the First Concussion-Specific Medical Device to Receive FDA Clearance 8/23/2016
Hemispherx (HEB) Announces Major Breakthrough: Approval For Commercial Sale Of Rintatolimod (U.S. Tradename: Ampligen) To Treat Severe Cases Of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) In The Argentine Republic 8/23/2016
FDA Green Lights Cochlear Limited's Nucleus MRI-Safe Hearing Aid 8/23/2016
Pfizer (PFE) Release: FDA Approves TROXYCA ER (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-Release Capsules CII With Abuse-Deterrent Properties For The Management Of Pain 8/22/2016
Alere (ALR) Nabs FDA Clearance for Alere i RSV Rapid Molecular Test 8/19/2016
Cianna Medical Wins Additional FDA Clearance for SAVI SCOUT Radar Localization System 8/18/2016
Quidel Corporation (QDEL) Grabs FDA Approval for Its Solana Trichomonas Assay for Diagnosis of Trichomoniasis 8/18/2016
Amerigen Pharmaceuticals Announces Final Approval From FDA For Generic Version Of Temodar 8/18/2016
Masimo (MASI) Announces CE Marking For RAS-45 Sensor For Rainbow Acoustic Monitoring Of Respiration Rate 8/18/2016
Aratana Therapeutics (PETX) Granted FDA Approval Of NOCITA (Bupivacaine Liposome Injectable Suspension) 8/16/2016
Bovie Medical Corporation (BVX) Receives FDA 510(k) Clearance for Its PlazXact Ablator 8/16/2016
Centric Medical Announces FDA Clearance of TARSA-LINK Bunion System 8/16/2016
DT MedTech Secures CE Marking And begins Active Distribution Of Hintermann Series H3 Lower Extremity Medical Devices 8/16/2016
FDA Approval for Edwards Lifesciences Corporation (EW)’s Intuity Elite Rapid Deployment Valve 8/15/2016
Oculus Innovative Sciences (OCLS) Receives Australian Approvals To Market Sterile Microcyn-Based Antimicrobial Solutions And Hydrogel Dressings 8/11/2016
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
Heron (HRTX) Announces FDA Approval Of SUSTOL (Granisetron) Extended-Release Injection For The Prevention Of Chemotherapy-Induced Nausea And Vomiting 8/10/2016
FDA Clears Boston Scientific (BSX)'s EMBLEM MRI S-ICD System 8/9/2016
DeGen Medical Snags FDA Clearance of CONNECT-L Transverse Connector with F1 MPS System 8/8/2016
Takeda (TKPYY) Receives Marketing Authorization In Canada For NINLARO (Ixazomib) In Relapsed/Refractory Multiple Myeloma 8/8/2016
FDA Approves Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) For Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma With Disease Progression On Or After Platinum-Containing Chemotherapy 8/8/2016
POP Medical Solutions Wins FDA Nod for Pelvic Device 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
Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) Approved By The European Commission (EC) For Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1 8/3/2016
FUJIFILM Announces 510(k) Clearance of FDR Visionary Suite and the Release of FDR Clinica X-Ray Components 8/3/2016
W. L. Gore & Associates Snags FDA Nod for Tigris Vascular Stent 8/2/2016
Amerigen Pharmaceuticals Announces Final Approval From FDA For Generic Version Of Lysteda 8/2/2016
Shire (SHPG) Wins FDA Approval of Adynovate with BAXJECT III Reconstitution System 8/1/2016
Ipsen (IPN.PA) Announces FDA Approval Of Dysport (Abobotulinumtoxina) For The Treatment Of Lower Limb Spasticity In Pediatric Patients Aged Two And Older 8/1/2016
Thermo Fisher Scientific (TMO) Release: New Immunoassay For The Specific Detection Of Hydrocodone Receives FDA 510 (K) Clearance 8/1/2016
Thermo Fisher Scientific (TMO) Receives FDA Clearance for EliA Anti-Thyroglobulin and Anti-Thyroid Peroxidase Tests for Autoimmune Thyroid Disease 8/1/2016
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
Silvergate Pharmaceuticals Release: FDA Approves Qbrelis, The First And Only Lisinopril Oral Solution 1 Mg/Ml For Pediatric Patients 6 Years Of Age And Older 8/1/2016
FDA OKs SPR Therapeutics' Pain Management Device 7/28/2016
Orthofix International NV (OFIX) Announces Japanese Approval And Market Launch Of PHOENIX Minimally Invasive Spinal Fixation System 7/28/2016
With Hopes of Bolstering Sanofi (SNY)’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S. 7/28/2016
DeGen Medical Wins FDA Clearance of F1 MPS System for JOUST Minimally Invasive Surgical Procedure 7/27/2016
Tandem Diabetes Care Announces Expanded Pediatric Indication Of T:Slim Insulin Pump For Ages 6 And Older 7/26/2016
Enanta Pharmaceuticals, Inc. Announces The U.S.FDA Has Approved AbbVie (ABBV)’s New, Once-Daily VIEKIRA XR (Dasabuvir, Ombitasvir, Paritaprevir And Ritonavir) For The Treatment Of Genotype 1 Chronic Hepatitis C Virus 7/26/2016
FDA Green Lights AbbVie (ABBV) Once-Daily Viekira XR for Hepatitis C 7/26/2016
Merck Animal Health Receives FDA Approval Of BRAVECTO (Fluralaner Topical Solution) For Cats And Dogs 7/22/2016
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
Eli Lilly (LLY) Release: U.S. FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults 7/19/2016
Allergan (AGN) And Adamas Pharmaceuticals (ADMS) Announce New Expanded Indication For NAMZARIC (Memantine And Donepezil Hydrochlorides) Extended Release For The Treatment Of Moderate To Severe Alzheimer's Disease 7/19/2016
Ajanta Pharma Announces The Approval And Launch Of Omeprazole And Sodium Bicarbonate Capsules 7/19/2016
Eisai Inc. (ESALF.PK) And Arena (ARNA) Announce FDA Approval Of BELVIQ XR (Lorcaserin Hcl) Extended-Release Tablets 7/19/2016
Medtronic (MDT) Nabs CE Mark Approval for Its Continuous Glucose Monitoring (CGM) System 7/19/2016
Avedro Receives Additional Indication For Photrexa Viscous, Photrexa And The KXL System For The Treatment Of Corneal Ectasia Following Refractive Surgery 7/19/2016
ANI Pharma Snags FDA Approval and Immediate Launch of Nilutamide Tablets, The First Generic Competitor to Nilandron 7/18/2016
Janssen Therapeutics Release: U.S. FDA Approves PREZISTA (Darunavir) For Use In Pregnant Women With HIV 7/18/2016
Perrigo (PRGO) Announces FDA Final Approval And Launch Of The Store Brand Equivalent To Zegerid OTC Capsules 7/18/2016
Syneron Candela Nabs FDA Clearance of High Energy UltraShape Power for Fat Destruction 7/18/2016
U.S. FDA Approves CSL Behring's Berinert As The First And Only Pediatric Treatment For Hereditary Angioedema (HAE) 7/18/2016
Health Canada Clears Abbott (ABT)'s Absorb Bioresorbable Stent 7/15/2016
Soberlink's Breathalyzer Nabs FDA Clearance for Medical Use 7/15/2016
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
Tandem Diabetes Care Wins FDA Clearance of Remote Software Update Tool for Insulin Pumps 7/14/2016
NovoCure Snags FDA Approval for Second Generation Optune System 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
St. Renatus, LLC Announces FDA Approval Of KOVANAZE (Tetracaine Hcl And Oxymetazoline Hcl) Nasal Spray For Use In Dentistry 7/13/2016
Medtronic (MDT) Gets FDA Nod for IN.PACT Admiral DCB 150 mm Lengths 7/13/2016
FDA Clears Expanded Approval of Pfizer (PFE)'s Best-Selling Pneumonia Vaccine 7/13/2016
Alafair Biosciences Receives FDA 510(k) Clearance for VersaWrap Tendon Protector 7/12/2016
Protein Sciences Corporation Release: 2016/17 Formulation Of Flublok Influenza Vaccine Receives FDA Approval 7/12/2016
Vision Research Unveils The Phantom VEO® Family Of High-Speed Cameras 7/12/2016
Shire (SHPG) Soars After the FDA Approves Long-Awaited Dry-Eye Disease Drug 7/12/2016
FDA Green Lights Genentech (RHHBY)'s Xolair for Allergic Asthma in Kids 7/11/2016
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
Lannett (LCI) Announces Approval And Launch Of Paroxetine Extended Release Tablets USP, 12.5 Mg, 25 Mg, 37.5 Mg 7/11/2016
Amgen (AMGN) Release: FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor 7/11/2016
AOP Orphan Pharmaceuticals AG Announces European "Approvable" Opinion Of Its Ultra-Short Acting Beta Blocker Rapibloc (Landiolol) 7/11/2016
West Pharmaceutical Services' SmartDose Drug Delivery Technology Platform Selected By Amgen (AMGN) For Pushtronex System 7/11/2016
Teligent Receives Two FDA Approvals For Topical Prescription Portfolio 7/8/2016
Novartis AG (NVS) Announces FDA Approval Of Xolair (Omalizumab) For Pediatric Allergic Asthma 7/8/2016
Galderma Laboratories Announces FDA Approval Of Full Prescription-Strength Differin Gel For Over-The-Counter Acne Use 7/8/2016
Luminex (LMNX) Snags FDA Clearance and CE-IVD Mark for the ARIES M1 System 7/6/2016
Seattle Genetics (SGEN) Announces European Commission (EC) Approval Of ADCETRIS (Brentuximab Vedotin) As Consolidation Treatment In Post-Transplant Hodgkin Lymphoma 7/6/2016
Takeda (TKPYY) Receives European Commission (EC) Approval Of ADCETRIS (Brentuximab Vedotin) For Consolidation Treatment In Post-Transplant Hodgkin Lymphoma 7/6/2016
FDA Clears INSYS' Syndros 7/5/2016
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
Laboratoire M2 Release: THYMOX HOOF Approved As Veterinary Drug 7/5/2016
Cartiva Announces FDA Premarket Approval For Cartiva Synthetic Cartilage Implant 7/5/2016
Biogen (BIIB) And AbbVie (ABBV)’s Once-Monthly ZINBRYTA (Daclizumab) Approved In European Union For Treatment Of Multiple Sclerosis 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
AbbVie (ABBV)'s HUMIRA (Adalimumab) Receives FDA Approval To Treat Adults With Non-Infectious Intermediate, Posterior And Panuveitis 7/1/2016
Health Canada Issued Notice of Compliance With Conditions Approving Janssen's Darzalex 6/30/2016
Concordia International Corp. Announces FDA Approval For New Photofrin Laser 6/30/2016
Janssen Biologics B.V. Release: SIMPONI Receives European Commission Approval For Treatment Of Polyarticular Juvenile Idiopathic Arthritis 6/30/2016
AtriCure (ATRC) Receives CE Mark For The AtriClip PRO2 Device 6/29/2016
JustRight Surgical to Receive FDA Clearance for Use of Device in Pediatric Patients 6/29/2016
SRS Medical Systems Receives CE Mark Approval for Spanner Prostate Stent 6/29/2016
SpeeDx Receives CE-IVD Mark for PlexPCR HSV-1&2, VZV Kit 6/29/2016
AstraZeneca PLC (AZN) Gets EU Approval For Zavicefta Antibiotic Treatment 6/28/2016
Lannett (LCI) Receives FDA Approval For Diazepam Oral Solution, 5 mg/5 mL 6/28/2016
Gilead (GILD) Release: FDA Approves Epclusa For Treatment Of Chronic Hepatitis C Virus Infection 6/28/2016
Health Canada Approves Janssen's Invega Trinza for Schizophrenia 6/27/2016
Life Spine's Centric Medical Wins FDA Clearance for Flatfoot Implant 6/24/2016
New Four-Strain Influenza Vaccine, VaxigripTetra, Regulatory Dossier From Sanofi Pasteur (SASY.PA) Now Approved In Europe 6/23/2016
St. Jude Medical (STJ) Expands Its Heart Failure Portfolio With Syncav CRT Technology, Providing Physicians Another Option For Managing Patients Not Responsive To Other Therapies 6/23/2016
Opko Health (OPK) Rockets on FDA Approval of Rayaldee Four Months Ahead of PDUFA Date 6/22/2016
Perrigo (PRGO) Announces FDA Clearance And Launch Of Non-GMO* Infant Formulas For The U.S. Store Brand Market 6/21/2016
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
Boston's REBIScan Snags FDA Approval for Pediatric Vision Scanner 6/17/2016
SpineGuard Wins FDA Clearance to Market PediGuard Threaded DSG Device 6/17/2016
Perrigo (PRGO) Announces FDA Approval Of The Generic Version Of Ofirmev Acetaminophen Injection 6/17/2016
Tyber Medical Expands FDA 510(k) Clearance Of Headed And Snap-Off Screws 6/15/2016
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
FDA Clears Aspire Bariatrics' Weight-Loss Stomach Tube Device 6/15/2016
Pfizer Canada Release: Health Canada Approves INFLECTRA (Biosimilar Infliximab) For Three Additional Indications: Crohn's Disease, Fistulising Crohn's Disease And Ulcerative Colitis 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
Espero Pharma Receives FDA Approval For GONITRO (Nitroglycerin) Sublingual Powder 6/14/2016
ANI Pharma Announces FDA Approval Of Oxcarbazepine Tablets 6/14/2016
TaiGen Biotechnology Receives Market Approval From The China Food And Drug Administration For Taigexyn (Nemonoxacin) 6/14/2016
Masimo (MASI) Snags FDA Approval for O3 Regional Oximetry 6/13/2016
FDA Approves Vaxchora, PaxVax, Inc.’s Single-Dose Oral Cholera Vaccine 6/13/2016
Lannett (LCI) Receives FDA Approval For Neomycin Sulfate Tablets USP, 500 mg 6/13/2016
SI-BONE Wins FDA Clearance for Updated Indication for the Ifuse Implant System 6/13/2016
Bay Area's Sandstone Diagnostics Wins FDA Nod for the Trak Male Fertility Testing System 6/10/2016
ViiV Healthcare Announces FDA Approval To Lower The Weight Limit For Dolutegravir In Children And Adolescents Living With HIV 6/10/2016
GenMark Diagnostics (GNMK) Achieves CE Mark For Its Eplex Sample-To-Answer System 6/9/2016
ThromboGenics NV (TBGNF) Receives US FDA Approval For New 'Already-Diluted' Formulation Of JETREA 6/8/2016
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
FDA Clears A New Latex Condom By O-RING Products With The Technology To Ease And Improve The Application Of Condoms 6/7/2016
Mayne Pharma Receives FDA Approval For Dofetilide Capsules, A Generic Alternative To TIKOSYN, And Is Awarded 180 Days Market Exclusivity 6/7/2016
Allergan (AGN) Announces FDA Approval Of BYVALSON (Nebivolol And Valsartan) 6/6/2016
Axonics Modulation Tech Receives CE Mark For Its Sacral Neuromodulation System For The Treatment Of Urinary And Fecal Dysfunction 6/6/2016
FDA Clears Cerêve Device For Treating Insomnia Patients By Helping Them Get To Sleep Faster 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
FDA Approves Biogen (BIIB) and AbbVie (ABBV)'s Once-Monthly MS Drug Zinbryta 6/2/2016
Allergan (AGN) Release: JUVÉDERM VOLBELLA XC Approved By U.S. FDA For Use In Lips And Perioral Rhytids 6/1/2016
Avenu Medical Receives CE Mark Approval For The Ellipsys Vascular Access System 6/1/2016
Spaulding Clinical Research Receives FDA 510(k) Clearance for 12-Lead ECG Device 5/31/2016
Perrigo (PRGO) Announces FDA Approval And Launch Of The Store Brand Equivalent To Flonase 5/31/2016
FDA Clears Blue Earth Diagnostics's Axumin (Fluciclovine F 18) Injection to Detect Recurrent Prostate Cancer 5/31/2016
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
Allergan (AGN) Receives FDA Approval Of TEFLARO (Ceftaroline Fosamil) For Pediatric Patients 5/31/2016
Eli Lilly (LLY) Release: U.S. FDA Approves Once-Daily Jentadueto XR (Linagliptin And Metformin Hydrochloride Extended-Release) Tablets For Adults With Type 2 Diabetes 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
Intercept Pharma (ICPT)'s Liver Drug Wins Accelerated Approval by the FDA 5/31/2016
DCGI Gives Limited Approval To Market First Allogeneic Cell Therapy Product In India 5/30/2016
Titan Pharma (TTNP) Receives FDA Approval for the First Ever Implantable Device for Opioid Dependency 5/27/2016
Braeburn Pharma Announces FDA Approves Probuphine (Buprenorphine) Implant: The First Implant For Treatment Of Opioid Dependence 5/27/2016
U.S. FDA Approves CSL Behring's AFSTYLA-- The First And Only Recombinant Factor VIII Single Chain Therapy For Hemophilia A 5/27/2016
Sanofi (SNY) Snags FDA Panel's Support for New Once-Daily Diabetes Combo iGlarLixi 5/26/2016
FDA Panel Backs St. Jude Medical (STJ)’s Amplatzer Stroke Device 5/26/2016
Ortho Kinematics Secures Health Canada Approval 5/26/2016
European Union Expands CE Mark Approval To Advanced Cooling Therapy’s Esophageal Cooling Device For 120 Hours Duration Of Use 5/25/2016
Bristol-Myers Squibb Canada (BMY) Release: Health Canada Approves DAKLINZA (Daclatasvir) For Difficult-To-Treat Hepatitis C Patient Populations 5/24/2016
Perimeter Medical Imaging Receives FDA Clearance for OTIS Optical Tissue Imaging System 5/24/2016
Seqirus Receives FDA Approval For FLUCELVAX QUADRIVALENT (Influenza Vaccine) For People Four Years Of Age And Older 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
Cerus (CERS) Release: Health Canada Approves INTERCEPT Blood System For Plasma 5/23/2016
Teijin Pharma’s FEBURIC (Febuxostat) Approved As Indication For Cancer Chemotherapy-Induced Hyperuricemia 5/23/2016
Genentech (RHHBY) Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years 5/20/2016
Aratana Therapeutics (PETX) Granted FDA Approval Of ENTYCE (Capromorelin Oral Solution) 5/18/2016
Bristol-Myers Squibb (BMY) Release: Opdivo (nivolumab) Granted First Approval Of A PD-1 Inhibitor In Hematology For The Treatment Of Classical Hodgkin Lymphoma Patients Who Have Relapsed Or Progressed After Auto-HSCT And Post-Transplantation Brentuximab Vedotin By The FDA 5/18/2016
Mission Pharmacal Company Receives FDA Approval For Liquid Potassium Iodide Oral Solution For Nuclear Emergency Management 5/17/2016
FDA Approves Eisai Inc. (ESALF.PK)'s LENVIMA (Lenvatinib) For The Treatment Of Patients With Advanced Renal Cell Carcinoma In Combination With Everolimus Following Prior Anti-Angiogenic Therapy 5/16/2016
Teligent Announces FDA Approval Of Triamcinolone Acetonide Ointment USP, 0.1% 5/16/2016
Orthofix International NV (OFIX) Wins FDA Approval of FORZA PTC Interbody Spacer System 5/16/2016
Thermo Fisher Scientific (TMO) Receives FDA Clearance For EliA Anti-Thyroglobulin And Anti-Thyroid Peroxidase Tests For Autoimmune Thyroid Disease 5/16/2016
Swedish Orphan Biovitrum: Alprolix (rFIXFc) Approved In The EU For The Treatment Of Hemophilia B 5/13/2016
FDA Clears Next-Gen Version of EndoGastric Solutions’ EsophyX Device 5/12/2016
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
Senseonics Nabs CE Mark Approval for the Eversense CGM System 5/11/2016
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
Integra LifeSciences (IART) Wins FDA Nod for Integra Omnigraft Dermal Regeneration Matrix 5/11/2016
European Commission (EC) Approves the First and Only Immuno-Oncology Combination, Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab) + Yervoy (Ipilimumab) Regimen, for Treatment of Advanced Melanoma 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
NinePoint Medical Snags FDA OK for Real-Time Targeting on Nvisionvle Device 5/10/2016
Pfizer Canada Release: Health Canada Approves New First-Line Treatment For Women Living With Metastatic Breast Cancer 5/10/2016
Theravance (THRX) Announces FDA Approval Of Expanded Label For VIBATIV (telavancin) 5/10/2016
Irvine Scientific Snags FDA Nod on Vitrification Media for Use With Oocytes 5/9/2016
TOLMAR Inc. Announces That FDA Approval Has Been Received For ELIGARD (Leuprolide Acetate For Injectable Suspension) Storage At Room Temperature For Up To 8 Weeks 5/6/2016
Signostics Wins FDA Nod for Uscan – The World’s First Smart Mobile-Connected Visualization Device Specialized for Urologic Care 5/6/2016
SentreHEART Receives 510k Approval for the LARIAT XT Suture Delivery Device 5/5/2016
FDA Clears Boston Scientific (BSX)'s Navigation-Enabled Ablation Catheters 5/4/2016



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