News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    

Clinical - Approvals
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
Boehringer Ingelheim Release: FDA Approves Jardiance To Reduce Cardiovascular Death In Adults With Type 2 Diabetes 12/5/2016
FDA Green Lights KYOCERA Medical's Initia Total Hip System, Featuring BIOCERAM AZUL Ceramic Femoral Head 12/5/2016
GlaxoSmithKline (GSK) Release: Relvar Ellipta 100/25 mcg Gains Approval In Japan For Use In Patients With COPD 12/2/2016
Nanowear Wins FDA OK for its Transformative Remote Diagnostic Monitoring Device 12/2/2016
Helsinn Integrative Care Wins FDA Nod for Medical Device Xonrid Gel 12/1/2016
Teligent Announces FDA Approval Of Clobetasol Propionate Lotion 0.05% 11/30/2016
Abbott (ABT) Bags CE Mark for i-STAT Alinity, a Pioneering, Handheld Blood Testing Platform 11/30/2016
Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Armodafinil Tablets (CIV) In 50mg, 150mg And 250 Mg Strengths (Nuvigil) 11/29/2016
Ariad (ARIA) Announces FDA Full Approval And Label Update For Iclusig (Ponatinib) Based On Long-Term Efficacy And Safety Data From Phase 2 PACE Clinical Trial 11/29/2016
Sound Options Tinnitus Treatments Release: Clinically Validated Tinnitus Treatment Gets FDA Clearance 11/29/2016
Lannett (LCI) Announces Approval For Metaxalone Tablets USP, 800 Mg 11/28/2016
Corsens Medical Announces Clearance of a 510(K) Pre-Marketing Notification With The FDA for the Corsens Cardiac Monitor 11/28/2016
International Biophysics' AffloVest Wins CE Mark Approval for Use in Europe and Elsewhere 11/28/2016
Exact Imaging Snags CE Mark Nod for Its ExactVu Prostate Imaging And Biopsy Micro-Ultrasound System 11/23/2016
Sanofi (SNY) Receives FDA Approval Of Soliqua 100/33 For The Treatment Of Adults With Type 2 Diabetes 11/22/2016
Johnson & Johnson (JNJ) Release: DARZALEX (Daratumumab) Approved By U.S. FDA In Combination With Two Standard Of Care Regimens For The Treatment Of Patients With Multiple Myeloma Who Have Received At Least One Prior Therapy 11/22/2016
Novo Nordisk A/S (NVO) Receives FDA Approval For Xultophy 100/3.6 (Insulin Degludec And Liraglutide Injection) 11/22/2016
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
Spectranetics (SPNC) Nabs CE Mark for Stellarex 0.014” Drug-Coated Balloon 11/22/2016
GlaxoSmithKline (GSK) Receives FDA Approval For Expanded Indication For Flulaval Quadrivalent (Influenza Vaccine) For Infants 6 Months And Older 11/21/2016
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
Ascensia Diabetes Care Wins FDA Nod for App-Enabled Contour Next One Blood Glucose Monitoring System 11/21/2016
EndoCeutics Release: FDA Approves Intrarosa For Postmenopausal Women Experiencing Pain During Sex 11/17/2016
Medtronic (MDT)'s Solitaire Stent Retriever Device Wins Expanded Nod From the FDA 11/16/2016
FDA Green Lights Medtronic (MDT)'s 'Smart' Defibrillator for Heart Patients 11/15/2016
Xtant Medical Snags FDA Nod to Use Allografts in the Stand-Alone Irix-C Cervical Cage 11/15/2016
LimFlow Receives CE Mark For Purely Percutaneous Critical Limb Ischemia (CLI) Technology Designed To Restore Perfusion For “No Option” Patients 11/15/2016
Lannett (LCI) Announces Approval For Memantine Hydrochloride Tablets USP, 5 mg And 10 mg 11/14/2016
Amgen (AMGN) Release: European Commission (EC) Approves Parsabiv (etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adults On Hemodialysis 11/14/2016
FDA Clears CapsoVision's CapsoCam Plus 11/14/2016
PTC Therapeutics (PTCT) Rockets as DMD Drug Wins Extended European Approval 11/11/2016
Bristol-Myers Squibb (BMY) Spiking on FDA Approval of Opdivo for Head and Neck Cancer 11/11/2016
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 Approves Gilead (GILD)’s Vemlidy (Tenofovir Alafenamide) For The Treatment Of Chronic Hepatitis B Virus Infection 11/10/2016
Keryx (KERX) Announces U.S. FDA Approval Of Second Contract Manufacturer For Auryxia (Ferric Citrate) 11/10/2016
Pfizer (PFE) Release: IBRANCE (Palbociclib) Receives Approval In European Union For The Treatment Of Women With HR+/HER2- Metastatic Breast Cancer 11/10/2016
Mallinckrodt (MNK) Announces U.S. FDA Approval Of OFIRMEV IV Bag Presentation 11/9/2016
Medtech Startup KATOR Wins FDA Nod for Knotless Suture Anchor System 11/9/2016
FDA Clearance For jioima Vaporflex And Legato Electrosurgical Probes 11/9/2016
Teva (TEVA) Announces Approval Of Generic Tribenzor In The United States 11/7/2016
Amgen (AMGN) Release: FDA Approves Expanded Use Of ENBREL (etanercept) To Treat Children With Chronic Moderate-To-Severe Plaque Psoriasis 11/7/2016
FDA Green Lights Propeller Health's Sensor for GlaxoSmithKline (GSK) Ellipta Inhaler 11/7/2016
St. Jude Medical (STJ) Gains CE Mark Approval For MRI Labeling Of Its Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker 11/7/2016
EOS Imaging Receives FDA 510(K) Clearance For kneeEOS 3D Surgical Planning Software For Total Knee Arthroplasty 11/7/2016
This Is Why Woodcock OKed Sarepta (SRPT)'s DMD Drug 11/4/2016
Pfizer (PFE)' Prevenar 13 Receives Approval For Use In Infants And Children In China 11/2/2016
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
Telehealth Startup Tyto Care Wins FDA Approval for Digital Telemedicine Stethoscope 11/1/2016
FDA OKs St. Jude Medical (STJ)'s New Device for Prevention of Recurrent Strokes in Certain Patients 10/31/2016
Acella Pharmaceuticals, LLC, Announces Approval Of A Generic Bromfed Antihistamine/Decongestant 10/28/2016
Swedish Orphan Biovitrum: Alprolix Approved In Switzerland For The Treatment Of Hemophilia B 10/28/2016
FDA Green Lights Corindus Vascular Robotics' Next Generation Robotic System 10/28/2016
Bay Area's BioTrace Medical Nabs FDA Clearance of Innovative Temporary Pacing Technology for the Heart 10/27/2016
PathoQuestAchieves CE Mark For The iDTECT Blood Test 10/27/2016
Apricus Biosciences (APRI) Announces Approval Of Vitaros For The Treatment Of Erectile Dysfunction In Greece 10/26/2016
RTI Surgical (RTIX) Announces Additional 510(k) Clearance for the Streamline OCT System 10/26/2016
Martindale Pharma Release: Clobazam Oral Suspension Approved In Seven European Countries 10/25/2016
Merck & Co. (MRK) Cements Lead Over Rivals After the FDA Grants Early Approval of Keytruda 10/25/2016
FDA Approves Merck & Co. (MRK)'s KEYTRUDA (Pembrolizumab) In Metastatic NSCLC For First-Line Treatment Of Patients Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score [TPS] Of 50 Percent Or More) With No EGFR Or ALK Genomic Tumor Aberrations 10/25/2016
Medtronic (MDT) Nabs FDA Clearance for New Lower Profile HawkOne 6F Directional Atherectomy System 10/25/2016
FDA Green Lights Spineology Inc.'s Rampart Duo Interbody Fusion System 10/25/2016
FDA Approves Merck & Co. (MRK)'s ZINPLAVA (Bezlotoxumab) To Reduce Recurrence Of Clostridium Difficile Infection (CDI) In Adult Patients Receiving Antibacterial Drug Treatment For CDI Who Are At High Risk Of CDI Recurrence 10/24/2016
Martindale Pharma Release: Clobazam Oral Suspension Approved In Seven European Countries 10/24/2016
Bio-Rad (BIO) Nabs FDA Nod for Its IH-1000 Blood Typing Instrument 10/24/2016
Roche (RHHBY) Wins FDA Approval for Cobas MPX Test 10/24/2016
FDA Clears Ortho Clinical Diagnostics' ORTHO VISION Max Analyzer for High-Volume Transfusion Medicine Labs 10/24/2016
Sarepta (SRPT) Gets No Love From the FDA's New Drugs Director 10/21/2016
FDA Green Lights Colorado Therapeutics' Novel Xenograft Implant for Soft Tissue Repairs 10/21/2016
MEDICREA Wins FDA Nod Clearances of Two New Specialized Components for Pediatric Deformity on PASS And Ligapass Platforms 10/21/2016
FDA Approves Eli Lilly (LLY)'s LARTRUVO (Olaratumab) In Combination With Doxorubicin For Soft Tissue Sarcoma 10/20/2016
Genentech (RHHBY)’s Tecentriq Wins Second Approval of the Year, This Time for Lung Cancer 10/19/2016
FDA Approves Genentech (RHHBY)'s Lucentis Pre-Filled Ranibizumab Syringe 10/17/2016
Teleflex Inc. (TFX) Snags FDA Green Light for the Arrow Midline with Chlorag+ard Technology 10/17/2016
Merz Aesthetics (Formerly Known as BioForm Medical, Inc.) Announces Three Year FDA Clearance For Cellfina System 10/17/2016
Protein Sciences Corporation Release: FDA Approves Flublok Quadrivalent Influenza Vaccine 10/12/2016
Alexza Pharma (ALXA) Announces U.S. Approval Of ADASUVE sNDA 10/11/2016
St. Jude Medical (STJ) Snags FDA Green Light and Launch of the New PressureWire X Guidewire 10/10/2016
Teleflex Medical Nabs FDA Clearance for ARROWJACC with Chlorag+ard Technology and Tunneler 10/10/2016
Viveve Snags FDA Nod for the Viveve System in the U.S. 10/7/2016
Fresenius Kabi AG Receives FDA 510(k) Clearance for the Aurora Xi Plasmapheresis System 10/7/2016
U.S. FDA Approves Orexo (ORXOF)'s Low Dose ZUBSOLV Buprenorphine And Naloxone Sublingual Tablets (CIII) 10/6/2016
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
Masimo (MASI) Announces CE Marking Of Rad-97 Pulse CO-Oximeter 10/6/2016
Second Teligent Topical Product Approved By Health Canada 10/5/2016
Siemens (SI) Wins FDA Nod for Xprecia Stride Coagulation Analyzer 10/5/2016
RA Medical Systems, Inc. Receives Approval In Europe For DABRA Atherectomy And Pharos Laser Phototherapy Systems 10/5/2016
Health Canada Approves Adapt Pharma's Naloxone Hydrochloride Nasal Spray To Treat Opioid Overdose 10/4/2016
St. Jude Medical (STJ)'s BurstDR Wins FDA Approval for Chronic Pain 10/4/2016
BioPharm Executive: Did the FDA Just Destroy Its Credibility? 10/3/2016
PaizaBio Receives CFDA Approval To Expand Fill-and-Finish Contract Manufacturing Operation China 10/3/2016
Jubilant Draximage Receives FDA Approval For RUBY-FILL Rubidium 82 Generator And Elution System 10/3/2016
Health Canada Approves First Teligent Topical Product 9/30/2016
Next Science Irrigation Solution Gains FDA Approval 9/29/2016
Vertex (VRTX) Release: FDA Approves ORKAMBI (Lumacaftor/Ivacaftor) For Use In Children With Cystic Fibrosis Ages 6 Through 11 Who Have Two Copies Of The F508del Mutation 9/29/2016
Medtronic (MDT) Nabs FDA Nod for World's First Artificial Pancreas for Diabetes 9/29/2016
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
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
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 Amgen (AMGN) Copy of AbbVie (ABBV)'s Blockbuster Humira 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
Janssen Biotech (JNJ) Release: FDA Approves STELARA (ustekinumab) For Treatment Of Adults With Moderately To Severely Active Crohn's Disease 9/26/2016
Otsuka Pharmaceutical Development & Commercialization, Inc. Release: FDA Approves Labeling Update Of REXULTI (brexpiprazole) For Maintenance Treatment Of Schizophrenia 9/26/2016
BrainScope Nabs FDA Win for First Handheld Medical Device for Traumatic Brain Injury 9/26/2016
NovaBone Products Secures Approval of CE Mark For Collagen Devices 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
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
Meet the Powerful Woman Behind the Scenes of Sarepta (SRPT)'s DMD Drug Approval 9/21/2016
FDA Approves Components for K2M'’s Mesa Spine Implant 9/21/2016
Heidelberg Engineering Receives FDA Clearance To Market SPECTRALIS OCT Glaucoma Module Premium Edition 9/21/2016
FDA Green Lights Life Spine's PRO-LINK Ti Stand-Alone Cervical Spacer System 9/21/2016
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
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
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
FDA Green Lights Bayer (BAY)'s Five-Year Contraceptive Kyleena 9/19/2016
FDA Clears NuVasive (NUVA)'s MAGEC System to be Surgically Implanted Using Its Reline Posterior Fixation System 9/19/2016
Medeon Biodesign Wins FDA OK for Abclose - Laparoscopic Port Site Closure Device 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
RTI Surgical (RTIX) Receives Regulatory Clearances, Expands Distribution Of Nanoss Bioactive In Australia, Europe 9/19/2016
FDA Clears Shockwave Medical's Lithoplasty System, the First-Ever Device That Uses Sound Waves for Peripheral Artery Disease 9/16/2016
Boston Scientific (BSX) Joins $10 Million Funding Round for Securus Medical 9/16/2016
FDA Approves the MED-EL's SYNCHRONY EAS Hearing Implant System 9/16/2016
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 Varian Medical Systems (VAR)'s Nexus DR Digital X-Ray Imaging System 9/15/2016
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
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
Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar To Receive Regulatory Approval In Canada 9/12/2016
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
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
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
Spirometrix, Inc. Receives CE Mark For Its Fenom PRO Point-Of-Care Breathalyzer 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
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
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
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
Amerigen Pharmaceuticals Announces Final Approval From FDA For Generic Version Of Temodar 8/18/2016
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
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
Heron (HRTX) Announces FDA Approval Of SUSTOL (Granisetron) Extended-Release Injection For The Prevention Of Chemotherapy-Induced Nausea And Vomiting 8/10/2016
Medtronic (MDT) Nabs CE Mark for Deep Brain Stimulation Therapy Software 8/10/2016
FDA Clears Boston Scientific (BSX)'s EMBLEM MRI S-ICD System 8/9/2016
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
Takeda (TKPYY) Receives Marketing Authorization In Canada For NINLARO (Ixazomib) In Relapsed/Refractory Multiple Myeloma 8/8/2016
DeGen Medical Snags FDA Clearance of CONNECT-L Transverse Connector with F1 MPS System 8/8/2016
POP Medical Solutions Wins FDA Nod for Pelvic Device 8/8/2016
ITM's Subsidiary ITG Receives Drug Approval For EndolucinBeta 8/4/2016
Masimo (MASI) Wins CE Marking for Pediatric O3 Regional Oximetry 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
Amerigen Pharmaceuticals Announces Final Approval From FDA For Generic Version Of Lysteda 8/2/2016
W. L. Gore & Associates Snags FDA Nod for Tigris Vascular Stent 8/2/2016
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
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
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 Injection For The Treatment Of Lower Limb Spasticity In Children Aged Two And Older 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
Thermo Fisher Scientific (TMO) Release: New Immunoassay For The Specific Detection Of Hydrocodone Receives FDA 510 (K) Clearance 8/1/2016
With Hopes of Bolstering Sanofi (SNY)’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S. 7/28/2016
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
DeGen Medical Wins FDA Clearance of F1 MPS System for JOUST Minimally Invasive Surgical Procedure 7/27/2016



//-->