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

Clinical - Approvals
Bay Area's Intersect ENT Grabs FDA Approval of Newest Steroid Releasing Implant, PROPEL Contour 2/24/2017
Celgene (CELG) Release: REVLIMID (Lenalidomide) Approved By European Commission (EC) As Monotherapy For The Maintenance Treatment Of Patients With Newly Diagnosed Multiple Myeloma After Autologous Stem Cell Transplantation 2/24/2017
IntelliPharmaCeutics Announces FDA Approval For 500 Mg And 750 Mg Generic Glucophage XR 2/24/2017
Celgene (CELG) Release: FDA Expands Indication For REVLIMID (Lenalidomide) As A Maintenance Treatment For Patients With Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (auto-HSCT) 2/23/2017
Amgen (AMGN) Wins European Commission (EC) Approval for Repatha Single-Dose Delivery Option 2/23/2017
Recovery Force Grabs FDA Nod for Active Compressions Product 2/23/2017
Celltrion Healthcare (068270.KQ) Release: Truxima, The First Biosimilar Mab In Oncology, Granted EU Marketing Authorization 2/22/2017
Chugai Pharma’s ALK Inhibitor "Alecensa" Approved In The EU 2/21/2017
Royal Philips Electronics N.V. (PHG) Snags FDA Approval for Inpatient Continuous Monitoring System 2/21/2017
Health Canada Approves Otsuka Pharma And Lundbeck (LUN.CO)'s REXULTI (Brexpiprazole) As A Treatment For Schizophrenia In Adults 2/20/2017
Voxello Snags FDA Nod for Noddle Speech Generation Device 2/20/2017
FDA Clears Expanded Indication for Medtronic (MDT)'s Freezor Xtra Cryoablation Catheter 2/17/2017
Perrigo (PRGO) Announces FDA Final Apffproval For Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution 2/17/2017
Boehringer Ingelheim Release: FDA Expands Approval Of SPIRIVA RESPIMAT (Tiotropium Bromide) Inhalation Spray For Maintenance Treatment Of Asthma In Children 2/16/2017
Boehringer Ingelheim Release: FDA Expands Approval Of Tiotropium Respimat For Maintenance Treatment Of Asthma In Children 2/16/2017
Zoetis (ZTS) Receives European Commission (EC) Approval For Stronghold Plus 2/16/2017
FDA Clears Valeant (VRX)'s New Psoriasis Drug, But With Strings Attached 2/16/2017
FlowAid Medical Tech Snags FDA Clearance for the FA100 SCCD 2/15/2017
The FDA Has Approved Tirosint-SOL, Levothyroxine In Liquid Solution For The American Market, IBSA Patent 2/15/2017
Eli Lilly (LLY) Release: European Commission (EC) Approves Once-Daily Olumiant Tablets For Treatment Of Adults With Moderate-To-Severe Active Rheumatoid Arthritis 2/14/2017
Sarepta (SRPT) Under Pressure As Marathon Pharma Emflaza's Wins FDA Approval for DMD 2/13/2017
BIOLASE Inc. (BIOL) Wins FDA Clearance of New Waterlase Express All-Tissue Laser System 2/10/2017
FDA Greenlights ReMAP’s 7D Image Guidance System for Spine Surgeries 2/10/2017
FDA Approves Amgen (AMGN)'s Parsabiv (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis 2/8/2017
FDA Approves Bio Products Laboratory's Gammaplex 10% For Treatment Of Primary Immunodeficiency And Chronic Immune Thrombocytopenic Purpura 2/7/2017
Innovus Pharma Announces The Approval To Commercialize Zestra In South Korea Through Its Partner J&H Co. LTD 2/3/2017
Bristol-Myers Squibb (BMY) Receives FDA Approval For Opdivo (Nivolumab) In Previously Treated Locally Advanced Or Metastatic Urothelial Carcinoma, A Type Of Bladder Cancer 2/3/2017
Sobi Obtains Approval From The European Commission (EC) For New Dosing Frequency Of Orfadin 2/2/2017
FDA OKs Abbott (ABT)'s Whole-Blood Molecular Zika Test 2/2/2017
Regeneron (REGN) And Sanofi (SNY) Announce First Approval Of Kevzara (Sarilumab) For The Treatment Of Moderately To Severely Active Rheumatoid Arthritis In Adult Patients By Health Canada 2/1/2017
FDA Grants New Clearance for NICO Corporation's Brain Surgery Technology 2/1/2017
Merck & Co. (MRK) Release: European Commission (EC) Approves KEYTRUDA (Pembrolizumab) For First-Line Treatment Of Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression With No EGFR Or ALK Positive Tumor Mutations 2/1/2017
Sanofi (SNY)'s Xyzal Allergy 24HR Approved For Over-The-Counter Use In The United States 2/1/2017
Endo International (ENDP) Announces U.S. FDA Approval Of Ephedrine Sulfate Injection, USP 1/31/2017
FDA Approves Allergan (AGN)'s sNDA For AVYCAZ (Ceftazidime And Avibactam) To Include New Phase III Data In Patients With Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis 1/30/2017
W. L. Gore & Associates Snags FDA Nod for First Balloon Expandable Stent Graft for Use in the Iliac Artery 1/30/2017
Teva (TEVA) Announces FDA Approval Of Two New RespiClick Maintenance Inhalers For The Treatment Of Asthma 1/30/2017
AstraZeneca PLC (AZN) Release: FDA Approves Symbicort For The Treatment Of Asthma In Pediatric Patients 1/30/2017
Sunovion’s Latuda (lurasidone HCl) Receives FDA Approval To Treat Adolescents With Schizophrenia 1/30/2017
Recordati Announces Marketing Approval For Cystadrops 1/27/2017
Gramercy Extremity Orthopedics Nabs a FDA Win for GEO Bone Screw System 1/26/2017
Boehringer Ingelheim Release: Jardiance (Empagliflozin) Becomes First Type 2 Diabetes Medicine In The EU To Include Cardiovascular Death Reduction Data In Label 1/26/2017
Allergan (AGN) Release: FDA Approves 72 Mcg Dose Of LINZESS (Linaclotide) For Adults With Chronic Idiopathic Constipation 1/26/2017
Globavir Biosciences, Inc. Release: Company’s Panglob Test Receives Approval For Sales And Distribution In India 1/25/2017
Adapt Pharma Release: NARCAN (Naloxone Hcl) Nasal Spray 2mg Approved By FDA 1/25/2017
Neural Analytics Release: Receives CE Mark For The Lucid System, A Next Generation, Portable Brain Monitoring Device 1/25/2017
Implanet Release: Medtech Announces Global Marketing Clearance of the New JAZZ FRAME 1/25/2017
Carmat (ALCAR.PA) Release: Company Awarded U.S. Regulatory Clearance For CANTAB Mobile 1/25/2017
Celgene (CELG) Release: Health Canada Approves REVLIMID Plus Dexamethasone As A First-Line Treatment For Patients Newly Diagnosed With Multiple Myeloma, Not Eligible For Transplant 1/24/2017
Bay Area's Prescient Surgical Wins FDA Approval for De Novo Clearance for CleanCision System 1/24/2017
Perrigo (PRGO) Release: Company Announces FDA Approval Of Its First-To-File Ab Rated Generic Version Of Topicort Spray, 0.25% 1/24/2017
FUJIFILM Release: FDA Approves The Company's Digital Breast Tomosynthesis Option For ASPIRE Cristalle Digital Mammography System 1/24/2017
BIOLASE Inc. (BIOL) Snags FDA Nod and Worldwide Launch of Its New Epic Pro Diode Laser System 1/23/2017
Synergy Pharma (SGYP) Release: TRULANCE (Plecanatide) Receives U.S. FDA Approval For The Treatment Of Adults With Chronic Idiopathic Constipation 1/20/2017
Allergan (AGN) Release: Pharma Announces FDA Approval Of Rhofade (Oxymetazoline Hydrochloride) Cream, 1% For The Topical Treatment Of Persistent Facial Erythema Associated With Rosacea In Adults 1/19/2017
Janssen Biotech (JNJ) Release: IMBRUVICA (Ibrutinib) Approved By FDA For Marginal Zone Lymphoma (MZL) Patients Who Require Systemic Therapy And Have Received At Least One Prior Anti-CD20-Based Therapy 1/19/2017
AbbVie (ABBV) Release: U.S. FDA Approves Imbruvica (Ibrutinib) As First Treatment Specifically Indicated For Relapsed/Refractory Marginal Zone Lymphoma (Mzl) - A Rare Type Of Non-Hodgkin's Lymphoma 1/19/2017
Edwards Lifesciences (EW) Nabs CE Mark for Hemosphere Blood Flow Monitor 1/19/2017
Advanced Cooling Therapy Release: Breakthrough Start-Up Advanced Cooling Therapy Receives CE Mark Approval for Use With New Control Unit 1/19/2017
SoCal's Modulated Imaging Wins FDA Nod for Ox-Imager CS System 1/19/2017
Apricus Biosciences (APRI) Release: Biotech Announces Approval Of Vitaros For The Treatment Of Erectile Dysfunction In Mexico 1/18/2017
Zealand Pharma  (ZEAL.CO) Release: EU Approval Of Suliqua Triggers $10 Million Milestone Payment To Company 1/18/2017
Teva (TEVA) Release: Company Receives FDA Approval For VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated With Proprietary Abuse Deterrence Technology 1/18/2017
WuXi AppTec Release: Novel Anti-IL-6 Antibody For Rheumatoid Arthritis From WuXi-MedImmune (AZN) Joint Venture Receives Clinical Trial Permit (CTP) From CFDA 1/18/2017
Precision Spine Release: Company Announces 510(k) Clearance Of The ShurFit ACIF 2C System 1/18/2017
MindChild Medical Inc. Release: Company Announces Clearance Of A 510(K) Pre-Marketing Notification With The FDA For The MERIDIAN M110 Fetal Monitoring System 1/17/2017
Intact Vascular Release: Company's Tack Endovascular System Secures CE Mark For Repair Of Dissections Following Angioplasty Below The Knee 1/17/2017
SpineGuard Release: Medical Device Receives FDA Clearance to Market Its DSG Integration Module for Making Pedicle Screws “Smart” 1/16/2017
Bay Area's Arterys Grabs Second FDA Win for Deep Learning, Image Analysis Software 1/12/2017
Egalet Release: Drug Company Receives FDA Approval For ARYMO ER (Morphine Sulfate) C-II, An Extended-Release Morphine Product Formulated With Abuse-Deterrent Properties For Treatment Of Chronic Pain 1/10/2017
Duchesnay Release: Company Is Pleased To Announce That Health Canada Has Granted Market Authorization For Mictoryl/Mictoryl Pediatric 1/10/2017
Servier Canada Release: Health Canada Approves New Heart Failure Treatment LANCORA To Reduce Mortality And Hospitalizations 1/10/2017
Orthofix International NV (OFIX) Bags FDA and CE Mark Approvals for New Bone Growth Stimulators 1/9/2017
Biocryst (BCRX) Receives Health Canada Approval For RAPIVAB® For The Treatment Of Influenza 1/9/2017
CSL Behring Release: AFSTYLA, For Haemophilia A, Receives European Commission Approval 1/9/2017
Debiopharm's Triptorelin 6-Month Formulation Receives Approval For The Treatment Of Central Precocious Puberty (CPP) In Europe 1/9/2017
Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Bendamustine Hcl Powder For IV (Treanda) 1/9/2017
Alphamab/3DMed Announce China Approval For PD-L1 Antibody Trial 1/9/2017
Globus Medical (GMED) Announces CE Mark For Excelsius GPS 1/6/2017
FDA Approves Genentech (RHHBY)’s Lucentis (Ranibizumab Injection) For Myopic Choroidal Neovascularization 1/6/2017
Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer 1/5/2017
Eli Lilly (LLY) Release: U.S. FDA Approves Supplemental New Drug Applications To Include Landmark Data In Product Labels For Synjardy (Empagliflozin/Metformin Hydrochloride), Synjardy XR (Empagliflozin/Metformin Hydrochloride Extended-Release) And Glyxambi (Empagliflozin/Linagliptin) Tablets 1/5/2017
Axonics Modulation Tech Sacral Neuromodulation System Receives Marketing Approval From Health Canada 1/5/2017
Flashback Technologies Announces U.S. FDA De Novo Clearance To Market The First Medical Device Containing Its Compensatory Reserve Index (CRI) Algorithm 1/4/2017
Lannett (LCI) Announces Approval For Lopinavir And Ritonavir Oral Solution USP, 80 Mg/20 Mg Per mL 1/4/2017
Sobi Canada Release: Health Canada Approves Orfadin Capsules For Treatment Of Hereditary Tyrosinaemia Type-1 (HT-1) 1/4/2017
Teligent Announces FDA Approval For Three Abbreviated New Drug Applications 1/3/2017
FDA Approval of Aurobindo (AUROPHARMA.BO)'s Two Drugs Sends Stock Up 1/3/2017
Ascensia Diabetes Care Receives Health Canada Approval For The App-Enabled CONTOUR NEXT ONE Blood Glucose Monitoring System 12/29/2016
NuVasive (NUVA) To Resume XLIF Procedures In Japan In First Quarter 2017 12/29/2016
FDA Approves First-Ever Treatment for Spinal Muscular Atrophy; Ionis Pharma (IONS), Biogen (BIIB) Seal Victory 12/29/2016
NanoVibronix Receives Health Canada Approval to Sell WoundShield in Canada 12/28/2016
BioNet Received Thai FDA Approval of the World's Only Available Recombinant Monovalent Acellular Pertussis (aP) Vaccine 12/27/2016
Shire (SHPG) Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), Pegylated] For Use In Children And Surgical Settings 12/27/2016
Nephros Inc. (NEP) Receives FDA 510(k) Clearance of HydraGuard 10" UltraFilter 12/27/2016
Alcon (ACL) Receives US FDA Approval for AcrySof IQ ReSTOR +3.0D Multifocal Toric Intraocular Lens for Cataract Patients 12/27/2016
Amphastar Pharmaceuticals, Inc. (AMPH), Armstrong Pharmaceuticals NDA Application Not Approved 12/27/2016
Eisai Company (ESALY.PK) Release: Anticancer Agent Treakisym Approved In Japan For Additional Indication As First-Line Treatment For Low-Grade B-Cell Non-Hodgkin's Lymphoma And Mantle Cell Lymphoma 12/22/2016
Celgene (CELG) Release: Oral PDE-4 Inhibitor, OTEZLA, Approved For The Treatment Of Plaque Psoriasis And Psoriatic Arthritis In Japan 12/20/2016
Perrigo (PRGO) Announces FDA Approvals For The Store Brand OTC Equivalents To Nicorette White Ice Mint Gum 12/20/2016
Clovis Oncology (CLVS) Announces FDA Accelerated Approval Of RUBRACA (Rucaparib) For The Monotherapy Treatment Of Advanced Ovarian Cancer In Women With Deleterious Germline Or Somatic BRCA Mutations... 12/20/2016
Novo Nordisk A/S (NVO) Receives FDA Approval Of Tresiba (Insulin Degludec Injection 100 U/Ml, 200 U/Ml) For Use In Children And Adolescents With Diabetes 12/19/2016
Pfizer (PFE) Receives Approval In The European Union For Nimenrix (Meningococcal Group A, C, W-135, And Y Conjugate Vaccine) In Infants Six Weeks Of Age And Older 12/19/2016
Merck & Co. (MRK) Release: KEYTRUDA (Pembrolizumab) Approved As First Anti-PD-1 Therapy In Japan For First-Line Treatment Of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express High Levels Of PD-L1 12/19/2016
Ironwood (IRWD) Announces Approval Of LINZESS (Linaclotide) In Japan For The Treatment Of Adults With IBS-C 12/19/2016
Japan’s Ministry of Health, Labour And Welfare Approves Gilead (GILD)’s Vemlidy For Patients With Chronic Hepatitis B Virus Infection 12/19/2016
Eisai Inc. (ESALF.PK) And Arena (ARNA) Announce Regulatory Approval Of BELVIQ (Lorcaserin Hcl) In Brazil 12/19/2016
St. Jude Medical (STJ) Wins FDA Clearance of EnSite Precision Cardiac Mapping System 12/15/2016
Health Canada Approves CSL Behring's AFSTYLA For The Treatment Of Hemophilia A 12/15/2016
Anacor (ANAC) Release: FDA Approves Eucrisa For Eczema 12/15/2016
Advanced Accelerator Applications Announces European Commission (EC) Approval Of SomaKit TOC 12/15/2016
FDA Green Lights Pfizer (PFE)'s Eczema Drug Eucrisa 12/15/2016
Janssen Release: Health Canada Approves STELARA For The Treatment Of Adults With Moderately To Severely Active Crohn's Disease 12/14/2016
Lumendi Wins FDA Clearance to Market DiLumen for Endolumenal Therapy 12/13/2016
Eli Lilly (LLY) Release: U.S. FDA Approves Synjardy XR (Empagliflozin/Metformin Hydrochloride Extended-Release) Tablets For Adults With Type 2 Diabetes 12/13/2016
Ferring Pharma Receives EU Approval For REKOVELLE (Follitropin Delta) 12/13/2016
Galderma Laboratories Announces FDA Approval Of Restylane Refyne And Restylane Defyne Dermal Fillers For Treatment Of "Laugh Lines" 12/12/2016
Biogen (BIIB) And AbbVie (ABBV) Receive Health Canada Approval Of Once-Monthly ZINBRYTA (Daclizumab Beta) For Multiple Sclerosis 12/9/2016
St. Jude Medical (STJ) Nabs CE Mark for Full Body MR Conditional Labeling for Proclaim SCS System Conditional Labeling 12/8/2016
Mederi Therapeutics Inc.'s Stretta Therapy For GERD Approved In China 12/8/2016
Provision Healthcare Receives FDA Clearance of the ProNova SC360 Proton Therapy System 12/8/2016
Boehringer Ingelheim Release: FDA Approves Jardiance (Empagliflozin) Tablets To Reduce The Risk Of Cardiovascular Death In Adults With Type 2 Diabetes And Established Cardiovascular Disease 12/6/2016
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
Abbott (ABT) Bags CE Mark for i-STAT Alinity, a Pioneering, Handheld Blood Testing Platform 11/30/2016
Teligent Announces FDA Approval Of Clobetasol Propionate Lotion 0.05% 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
Novo Nordisk A/S (NVO) Receives FDA Approval For Xultophy 100/3.6 (Insulin Degludec And Liraglutide Injection) 11/22/2016
Spectranetics (SPNC) Nabs CE Mark for Stellarex 0.014” Drug-Coated Balloon 11/22/2016
Sanofi (SNY) Receives FDA Approval Of Soliqua 100/33 For The Treatment Of Adults With Type 2 Diabetes 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
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
Ascensia Diabetes Care Wins FDA Nod for App-Enabled Contour Next One Blood Glucose Monitoring System 11/21/2016
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
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
Xtant Medical Snags FDA Nod to Use Allografts in the Stand-Alone Irix-C Cervical Cage 11/15/2016
FDA Green Lights Medtronic (MDT)'s 'Smart' Defibrillator for Heart Patients 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
FDA Clears CapsoVision's CapsoCam Plus 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
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
Keryx (KERX) Announces U.S. FDA Approval Of Second Contract Manufacturer For Auryxia (Ferric Citrate) 11/10/2016
FDA Approves Gilead (GILD)’s Vemlidy (Tenofovir Alafenamide) For The Treatment Of Chronic Hepatitis B Virus Infection 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
FDA Clearance For jioima Vaporflex And Legato Electrosurgical Probes 11/9/2016
Mallinckrodt (MNK) Announces U.S. FDA Approval Of OFIRMEV IV Bag Presentation 11/9/2016
Medtech Startup KATOR Wins FDA Nod for Knotless Suture Anchor System 11/9/2016
FDA Green Lights Propeller Health's Sensor for GlaxoSmithKline (GSK) Ellipta Inhaler 11/7/2016
Teva (TEVA) Announces Approval Of Generic Tribenzor In The United States 11/7/2016
Amgen (AMGN) Release: FDA Approves Expanded Use Of ENBREL (etanercept) To Treat Children With Chronic Moderate-To-Severe Plaque Psoriasis 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
Advanced Accelerator Applications Announces Swiss Marketing Authorization For Two PET Diagnostic Products 11/2/2016
Pfizer (PFE)' Prevenar 13 Receives Approval For Use In Infants And Children In China 11/2/2016
Telehealth Startup Tyto Care Wins FDA Approval for Digital Telemedicine Stethoscope 11/1/2016
Bristol-Myers Squibb Canada (BMY) Release: First-Ever Combination Of Two Immuno-Oncology Agents For Metastatic Melanoma Approved By Health Canada 11/1/2016
FDA OKs St. Jude Medical (STJ)'s New Device for Prevention of Recurrent Strokes in Certain Patients 10/31/2016
FDA Green Lights Corindus Vascular Robotics' Next Generation Robotic System 10/28/2016
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
PathoQuestAchieves CE Mark For The iDTECT Blood Test 10/27/2016
Bay Area's BioTrace Medical Nabs FDA Clearance of Innovative Temporary Pacing Technology for the Heart 10/27/2016
RTI Surgical (RTIX) Announces Additional 510(k) Clearance for the Streamline OCT System 10/26/2016
Apricus Biosciences (APRI) Announces Approval Of Vitaros For The Treatment Of Erectile Dysfunction In Greece 10/26/2016
Merck & Co. (MRK) Cements Lead Over Rivals After the FDA Grants Early Approval of Keytruda 10/25/2016
Medtronic (MDT) Nabs FDA Clearance for New Lower Profile HawkOne 6F Directional Atherectomy System 10/25/2016
Martindale Pharma Release: Clobazam Oral Suspension Approved In Seven European Countries 10/25/2016
FDA Green Lights Spineology Inc.'s Rampart Duo Interbody Fusion System 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
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
Bio-Rad (BIO) Nabs FDA Nod for Its IH-1000 Blood Typing Instrument 10/24/2016
Martindale Pharma Release: Clobazam Oral Suspension Approved In Seven European Countries 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
MEDICREA Wins FDA Nod Clearances of Two New Specialized Components for Pediatric Deformity on PASS And Ligapass Platforms 10/21/2016
FDA Green Lights Colorado Therapeutics' Novel Xenograft Implant for Soft Tissue Repairs 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
Teleflex Inc. (TFX) Snags FDA Green Light for the Arrow Midline with Chlorag+ard Technology 10/17/2016
FDA Approves Genentech (RHHBY)'s Lucentis Pre-Filled Ranibizumab Syringe 10/17/2016
Merz Aesthetics (Formerly Known as BioForm Medical, Inc.) Announces Three Year FDA Clearance For Cellfina System 10/17/2016



//-->