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Clinical - Approvals
Gilead (GILD) Release: FDA Approves Epclusa For Treatment Of Chronic Hepatitis C Virus Infection 6/28/2016
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
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
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
Acutus Medical Receives CE Mark For The Acqmap 3D High Resolution Imaging And Mapping System 5/4/2016
Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Lacosamide Tablets (Vimpat) 5/4/2016
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
Allergan (AGN) Receives FDA Approval And Launches First Generic Version Of CRESTOR (Rosuvastatin) 5/2/2016
Eisai Inc. (ESALF.PK) Announces FDA Approval Of FYCOMPA (Perampanel) Oral Suspension For Adjunctive Therapy In The Treatment Of Partial-Onset Seizures And Primary Generalized Tonic-Clonic Seizures 5/2/2016
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
Perrigo (PRGO) Announces FDA Approval And Launch Of The Generic Version Of BenzaClin Pump Topical Gel 5/2/2016
FDA Green Lights Medtronic (MDT)'s Afib-Detecting Visia ICD 5/2/2016
Flamel Technologies (FLML) Receives FDA Approval Of Akovaz 5/2/2016
Synaptive Medical Receives FDA Clearance for Health Informatics Platform 5/2/2016
FDA Clears Acadia (ACAD)'s NUPLAZID, the First Drug for Psychosis Linked to Parkinson's 5/2/2016
FDA Approves Bayer (BAY)'s Gadavist (Gadobutrol) Injection As First Contrast Agent For Use With Magnetic Resonance Angiography Of Supra-Aortic Arteries 4/29/2016
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
Sobi Release: FDA Approves ORFADIN (Nitisinone) Oral Suspension 4/27/2016
Boston Scientific (BSX) Snags FDA Nod for ImageReady MR-Conditional Pacing System 4/26/2016
AtriCure (ATRC) Wins FDA Clearance for New AtriClip Device 4/26/2016
Intuity Med Wins FDA Approval to Market POGO Automatic Blood Glucose Monitoring System 4/26/2016
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
Enanta Pharmaceuticals, Inc. Announces FDA Has Approved AbbVie (ABBV)’s Supplemental New Drug Application For Use Of VIEKIRA PAK Without Ribavirin In Genotype 1b Chronic Hepatitis C Patients With Compensated Cirrhosis 4/25/2016
Exactech (EXAC) Nabs FDA 510(k) Clearance for Vantage Total Ankle 4/25/2016
W. L. Gore & Associates Excluder Iliac Branch Endoprosthesis Gains Health Canada Approval 4/21/2016
FUJIFILM VisualSonics Announces 510(K) Clearance For The World's First Ultra High Frequency Ultrasound For Humans 4/21/2016
Oculus Innovative Sciences (OCLS) Grabs FDA Approval for Lasercyn 4/20/2016
Ortho Kinematics Nabs CE Mark Approval for Spinal Motion Analyzer 4/20/2016
Avedro Wins FDA Approval for Photrexa Viscous, Photrexa and the KXL System for Corneal Cross-Linking 4/19/2016
Ortho Kinematics Secures CE Mark Approval To Support International Expansion 4/19/2016
Boehringer Ingelheim Release: FDA Approves Gilotrif (Afatinib) As New Oral Treatment Option For Patients With Squamous Cell Carcinoma Of The Lung 4/18/2016
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
Praxair Canada Receives Approval For Sale Of Noxivent Nitric Oxide 4/14/2016
AtriCure (ATRC) Snags 510(K) Clearance for the Cryoform Cryoablation Probe 4/12/2016
ndd Medical’s Easyone Spirometer Is The First PFT Device Approved For New Coal Miner Surveillance Program 4/12/2016
AbbVie (ABBV) Receives FDA Accelerated Approval Of Venclextatm(Venetoclax) Tablets, The First BCL-2 Inhibitor In Relapsed/Refractory Chronic Lymphocytic Leukemia Patients With 17p Deletion 4/12/2016
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
EOS Imaging Receives FDA Approval For Spineeos, Its Online 3D Planning Solution For Spine Surgery 4/12/2016
FDA Green Lights AbbVie (ABBV), Genentech (RHHBY)'s New Chronic Lymphocytic Leukemia Drug Venclexta 4/12/2016
Profound Medical Receives CE Mark Approval For TULSA-PRO 4/11/2016
FDA Green Lights Abiomed (ABMD)'s Device to Treat Cardiac Shocks 4/8/2016
FDA OKs Advanced Surgical Concepts' Tissue Container for Laparoscopic Device 4/8/2016
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
Ligand (LGND) Release: Revolade Approved In EU As First In Class Therapy For Children Aged 1 Year And Above With Chronic ITP 4/7/2016
FDAAdvisoryCommittee.com Approves Celltrion (068270.KQ)’s INFLECTRA, the First Cheaper Version of Johnson & Johnson (JNJ) Blockbuster Remicade 4/7/2016
K2M’s MESA Mini And DENALI® Mini Spinal Systems Receive Additional FDA Clearance For Posterior Cervical Spine Fixation 4/6/2016
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
FDA Approves Gilead (GILD)'s Next-Generation HIV Drug Descovy 4/5/2016
ANI Pharma Announces FDA Approval Of Oxycodone Capsules, 5mg 4/5/2016
Ekso Bionics (EKSO) GT Robotic Exoskeleton Cleared by the FDA for Use With Stroke and Spinal Cord Injury Patients 4/4/2016
Health Canada Approves BioPharmX Study Of Violet Iodine 4/4/2016
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
Sonendo Wins FDA 510(k) Clearance for the Next-Gen of the GentleWave System 3/29/2016
St. Jude Medical (STJ) Announces CE Mark Approval and Launch of Expanded Selection of Quadripolar Pacing Leads 3/29/2016
Lannett (LCI) Receives FDA Approvals For Two Products 3/29/2016
Great Basin Scientific Wins FDA 510(k) Clearance for First Multiplex Panel 3/28/2016
Anika Therapeutics (ANIK) Wins CE Mark Approval For Cingal For The Treatment Of Pain Associated With Osteoarthritis Of The Knee 3/28/2016
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
ZOLL (ZOLL) Receives Approval To Market Intravascular Temperature Management Technology For Sudden Cardiac Arrest In Japan 3/28/2016
Kedrion Receives FDA Approval To Package Koate Double Viral Inactivation (DVI) Antihemophilic Factor (Human) With Mix2Vial Needle-Free Transfer Device 3/28/2016
Bay Area's Intersect ENT Wins FDA Approval of Additional Indication for PROPEL Mini Sinus Implant 3/24/2016
Baxter International (BAX) Completes CE Mark For Expanded Indication Of HEMOPATCH, An Innovative Surgical Patch, In European Union 3/24/2016
Great Basin Scientific Receives FDA 510(k) Clearance for Shiga Toxin Direct Test 3/23/2016
FDA Clears Stimwave's Miniature Peripheral Nerve Stimulator (PNS), Providing The Only Full Body Wireless Pain Relief Solution To Market 3/23/2016
Eli Lilly (LLY) Wins FDA Approval for Psoriasis Drug Taltz 3/23/2016
Teva (TEVA) Announces FDA Approval Of CINQAIR (Reslizumab) Injection 3/23/2016
Aratana Therapeutics (PETX) Granted First FDA Approval 3/22/2016
LEO Pharma Receives Scientific Approval Of Enstilar For The Treatment Of Psoriasis In EU 3/21/2016
Apira Science’s Igrow Becomes First Hair Growth Device Cleared By China Food And Drug Administration (CFDA) 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
Elusys Therapeutics, Inc. Receives FDA Approval For ANTHIM (obiltoxaximab) Injection For The Treatment And Prophylaxis Of Inhalational Anthrax 3/21/2016
Breckenridge Pharmaceutical, Inc. Announces Approval For Gabapentin Oral Solution 3/18/2016
FDA Gives Thumbs Up to Bayer (BAY)'s Hemophilia A Drug Kovaltry 3/17/2016
Merz Pharma Group Announces European Approval Of Bocouture For The Treatment Of Upper Facial Lines 3/17/2016
FDA OKs Expanded Use of Cerus (CERS)'s INTERCEPT Blood System 3/16/2016
FDA Grants Spectrum Pharma (SPPI) Approval Of EVOMELA (Melphalan) For Injection 3/15/2016
Ligand (LGND) Partner Spectrum Pharma (SPPI) Receives FDA Approval Of EVOMELA (Melphalan) For Injection 3/15/2016
Nemaura Medical Announces Receipt Of Notification Of CE Approval For Its Sugarbeat Continuous Glucose Monitoring System 3/15/2016
Intuitive Surgical (ISRG) Wins FDA Approval for New EndoWrist Stapler 3/14/2016
Pfizer (PFE) Release: XALKORI (Crizotinib) Approved By U.S. FDA For The Treatment Of Patients With ROS1-Positive Metastatic Non-Small Cell Lung Cancer 3/14/2016
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
Life Spine Announces FDA Clearance of PROLIFT Expandable Interbody System 3/8/2016
BioStable Announces CE Mark Approval For The HAART 300 Aortic Annuloplasty Device 3/8/2016
FDA Green Lights CSL Behring's Idelvion for Hemophilia B 3/7/2016
Avita Medical Wins FDA Approval for Increase in Compassionate Use of ReCell Patient Cases 3/7/2016
Janssen Biotech Inc. (JNJ) Release: U.S. FDA Approves IMBRUVICA (ibrutinib) For First-Line Treatment Of Chronic Lymphocytic Leukemia 3/7/2016
Gold Standard Diagnostics Receives FDA Clearance for the AIX1000TM System 3/7/2016
Stryker Wins FDA for Tritanium PL Posterior Lumbar Cage 3/4/2016
AstraZeneca PLC (AZN) Release: FDA Approves New Indication For FASLODEX (fulvestrant) 3/3/2016
FDA Green Lights Gilead (GILD)’s Odefsey to Treat HIV-1 Infection in Certain Patients 3/2/2016
Reapplix Snags FDA Approval for Its 3C Patch System 3/1/2016
Becton, Dickinson and Company (BDX) Grabs CE Mark for Next-Gen Blood Separation Technology 3/1/2016
Thermo Fisher Scientific (TMO) Announces Expanded FDA Clearance For Its B·R·A·H·M·S PCT Sepsis Biomarker 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
CoorsTek Medical Announces FDA 510(K) Clearance For Total Hip System Incorporating Cerasurf-P Implantable Ceramic Components 3/1/2016
FDA Approves New Indication For Novartis Pharmaceuticals Corporation (NVS) Drug Afinitor For Progressive, Nonfunctional GI And Lung Neuroendocrine Tumors (NET) 2/29/2016
EOS Imaging Receives CE Mark For Spineeos Online 3D Surgical Planning Solution For The EOS System 2/29/2016
FDA Green Lights Genentech (RHHBY)'s Gazyva for Patients with Previously Treated Follicular Lymphoma 2/26/2016
Allergan (AGN) Announces FDA Approval Of ACZONE (dapsone) Gel, 7.5% For Treatment Of Acne Vulgaris 2/26/2016
Teligent Announces FDA Approval Of Desoximetasone Ointment USP 0.25% 2/26/2016



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