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Clinical - Approvals
BioPharm Executive: Did the FDA Just Destroy Its Credibility? 9/28/2016
Medtronic (MDT) Snags FDA Nod for TrailBlazer Angled Peripheral Support Catheter 9/28/2016
Soterix Medical Launches PainX tDCS Treatment In Canada With Health Canada Approval 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
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
BrainScope Nabs FDA Win for First Handheld Medical Device for Traumatic Brain Injury 9/26/2016
Novartis AG (NVS) Receives Three New FDA Approvals For The Expanded Use Of Ilaris For Patients With Rare Periodic Fever Syndrome Conditions 9/26/2016
Otsuka Pharmaceutical Development & Commercialization, Inc. Release: FDA Approves Labeling Update Of REXULTI (brexpiprazole) For Maintenance Treatment Of Schizophrenia 9/26/2016
Janssen Biotech (JNJ) Release: FDA Approves STELARA (ustekinumab) For Treatment Of Adults With Moderately To Severely Active Crohn's Disease 9/26/2016
NovaBone Products Secures Approval of CE Mark For Collagen Devices 9/26/2016
FDA Clears Amgen (AMGN) Copy of AbbVie (ABBV)'s Blockbuster Humira 9/26/2016
FDA Clears Global Kinetics's Parkinson’s Kinetigraph, A Wrist-Worn Device for 24/7 Monitoring of Parkinson’s Disease Patients 9/22/2016
Meet the Powerful Woman Behind the Scenes of Sarepta (SRPT)'s DMD Drug Approval 9/21/2016
FDA Green Lights Life Spine's PRO-LINK Ti Stand-Alone Cervical Spacer System 9/21/2016
FDA Approves Components for K2M'’s Mesa Spine Implant 9/21/2016
Janssen Pharmaceutical Release: U.S. FDA Approves INVOKAMET XR (Canagliflozin / Metformin Hydrochloride Extended-Release) For The Treatment Of Adults With Type 2 Diabetes 9/21/2016
Heidelberg Engineering Receives FDA Clearance To Market SPECTRALIS OCT Glaucoma Module Premium Edition 9/21/2016
KVK Tech Announces FDA-Approval Of Lomaira (Phentermine Hydrochloride USP) 8 Mg Tablets, CIV, A Low-Cost, Low-Dose Phentermine That Can Be Used Up To Three Times Daily For Weight Reduction 9/20/2016
Lannett (LCI) Announces Approval For Buprenorphine And Naloxone Sublingual Tablets, 2 mg/0.5 mg And 8 mg/2 mg 9/20/2016
Approving A Muscular Dystrophy Drug Exposes A Civil War At The FDA 9/20/2016
Victory at Last! Sarepta (SRPT) Stock Doubles as the FDA Finally Approves DMD Drug 9/20/2016
Sarepta (SRPT) Announces FDA Accelerated Approval Of EXONDYS 51 (Eteplirsen) Injection, An Exon Skipping Therapy To Treat Duchenne Muscular Dystrophy (DMD) Patients Amenable To Skipping Exon 51 9/19/2016
RTI Surgical (RTIX) Receives Regulatory Clearances, Expands Distribution Of Nanoss Bioactive In Australia, Europe 9/19/2016
Medeon Biodesign Wins FDA OK for Abclose - Laparoscopic Port Site Closure Device 9/19/2016
FDA Clears NuVasive (NUVA)'s MAGEC System to be Surgically Implanted Using Its Reline Posterior Fixation System 9/19/2016
FDA Green Lights Bayer (BAY)'s Five-Year Contraceptive Kyleena 9/19/2016
Boston Scientific (BSX) Receives CE Mark For LOTUS Edge Valve System 9/19/2016
Riverain Technologies Release: FDA Clears Way For ClearRead CT Software 9/19/2016
Boston Scientific (BSX) Joins $10 Million Funding Round for Securus Medical 9/16/2016
FDA Clears Shockwave Medical's Lithoplasty System, the First-Ever Device That Uses Sound Waves for Peripheral Artery Disease 9/16/2016
FDA Approves the MED-EL's SYNCHRONY EAS Hearing Implant System 9/16/2016
FDA Clears Varian Medical Systems (VAR)'s Nexus DR Digital X-Ray Imaging System 9/15/2016
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
Brainsway (BRSYF.PK) Attains Regulatory Approval for Marketing Deep TMS In Mexico 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
Novogen Limited (NVGN) Release: US FDA Approves Investigational New Drug (IND) Application For Cantrixil(TM) (TRX-E-002-1) In Ovarian Cancer 9/12/2016
Obalon Wins FDA Approval of Obalon Balloon System 9/12/2016
Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar To Receive Regulatory Approval In Canada 9/12/2016
NovaBay (NBY)'s Neutrox Product Line Nabs CE Mark for the European Union 9/12/2016
Dechra Receives FDA Approval For First U.S. Generic Entrant Antibiotic 9/9/2016
Crescita Therapeutics Announces Approval Of Pliaglis In Mexico 9/9/2016
Apricus Biosciences (APRI) Announces Approval Of Vitaros For The Treatment Of Erectile Dysfunction In Argentina 9/8/2016
Carestream Health’s OnSight 3D Extremity System Receives FDA 510(k) Clearance 9/8/2016
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s ORENCIA (Abatacept) For The Treatment Of Highly Active And Progressive Disease In Adult Patients With Rheumatoid Arthritis Not Previously Treated With Methotrexate 9/6/2016
WOUNDCHEK Protease Status Receives Market Clearance In Australia 9/6/2016
FDA Clears Expanded Use of Amgen (AMGN)'s Blincyto 9/2/2016
Medicure (MCU) Release: FDA Approves New AGGRASTAT Product Format 9/1/2016
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
Spirometrix, Inc. Receives CE Mark For Its Fenom PRO Point-Of-Care Breathalyzer 8/31/2016
Pfizer (PFE) Release: Xalkori (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With Ros1-Positive Advanced Non-Small Cell Lung Cancer 8/31/2016
Bluegrass Vascular Wins CE Mark Approval and Announces Successful Commercial Use of The Surfacer Inside-Out Access Catheter System 8/30/2016
Apira Science’s iGrow Becomes First Wearable Laser Device To Be Cleared By ANVISA In Brazil 8/30/2016
Seqirus Receives FDA Approval For AFLURIA QUADRIVALENT (Influenza Vaccine) For People 18 Years Of Age And Older 8/29/2016
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
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



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