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Clinical - Approvals
Intercept Pharma (ICPT) Release: Health Canada Grants Approval For Ocaliva (Obeticholic Acid) For The Treatment Of Patients With Primary Biliary Cholangitis (PBC) 5/26/2017
Athenex And Its Partner, Guangzhou Xiangxue Pharma, Announced Chinese FDA IND Approval To Begin Clinical Trials Of KX-02 Tablet For Glioblastoma 5/25/2017
SCIEX Nabs First FDA-Cleared Vitamin D Assay Kit For Mass Spectrometry 5/24/2017
Merck & Co. (MRK)’s Ace Keytruda Wins Landmark Approval for Tumors With Particular Genetic Features 5/24/2017
The Lustgarten Foundation for Pancreatic Cancer Research Release: FDA Approves Pembrolizumab for Pancreatic Cancers With Mismatch Repair Deficiency 5/24/2017
Market Just Got More Crowded as Regeneron (REGN), Sanofi (SNY)'s New RA Drug Wins FDA Approval 5/24/2017
Second Drug Receives FDA Approval For Bladder Cancer Based On Research Led By NYU Langone Medical Center 5/22/2017
Cook Medical Wins FDA Approval for Device to Treat Rare Birth Defect 5/22/2017
Immune Therapeutics Announces NAFDAC Approval For Marketing And Distribution Of Lodonal 5/22/2017
FDA Clears Soterix Medical's IontoDC System 5/22/2017
FDA Green Lights Genentech (RHHBY)’s Actemra for Giant Cell Arteritis 5/22/2017
Merck & Co. (MRK)'s Immuno-Oncology Star Racks Up Two New Bladder Cancer Approvals 5/19/2017
Swedish Orphan AB - Elocta Approved In The Kingdom Of Saudi Arabia For The Treatment Of Haemophilia A 5/18/2017
Bay Area's MyoScience Wins FDA Nod for Iovera Knee Osteoarthritis Device 5/18/2017
Vertex (VRTX) Release: FDA Approves KALYDECO (Ivacaftor) For More Than 900 People Ages 2 And Older With Cystic Fibrosis Who Have Certain Residual Function Mutations 5/18/2017
Abon Pharmaceuticals Received Approval from the U.S. FDA for Clofarabine Injection 5/17/2017
Bristol-Myers Squibb Canada Release: Health Canada Approves OPDIVO (Nivolumab) For The Treatment Of Squamous Cell Carcinoma Of The Head And Neck 5/17/2017
Swedish Orphan Biovitrum - Orfadin Capsules Approved In The Kingdom Of Saudi Arabia For The Treatment Of Hereditary Tyrosinemia Type 1 5/17/2017
Dr. Reddy's Laboratories Ltd. (RDY) Announces FDA Approval For The Launch Of Doxorubicin Hydrochloride Liposome Injection In The U.S. Market 5/17/2017
Sweden's BrainCool Enters U.S. Market With FDA 510(k) Clearance for IQool System for Temperature Management 5/17/2017
Lannett (LCI) Announces Approval For Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL) 5/16/2017
FDA Clears Body Vision's LungVision Navigation System, Revolutionizing Lung Cancer Detection and Treatment 5/16/2017
Pharmadax Receives FDA Approval For A Generic Version Of Seroquel XR 5/16/2017
Shockwave Medical Snags CE Mark for Coronary Lithoplasty System 5/15/2017
TearLab (TEAR) Osmolarity System Receives Brazilian Regulatory Approval 5/12/2017
Intellipharmaceutics (IPCI) Announces FDA Final Approval Of Generic Seroquel XR 5/11/2017
FDA Approves Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) As First-Line Combination Therapy With Pemetrexed And Carboplatin For Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective Of PD-L1 Expression 5/11/2017
Medtronic (MDT) First to Receive FDA Clearance for MRI-Safe Pacemaker Devices 5/11/2017
Obalon Receives Regulatory Approvals To Commercialize In Select Middle East Markets 5/11/2017
Step Aside AstraZeneca PLC (AZN): Merck KGaA (MKGAF.PK), Pfizer (PFE)'s Immuno-Onco Drug Nabs FDA Approval for Bladder Cancer 5/10/2017
ADImmune Corporation's Quadrivalent Flu Vaccine Approved By TFDA 5/10/2017
Life Spine Wins FDA 510(k) Clearance of the CRANIAL FUSION System With SOLSTICE Screws for Cervical Spine Indications 5/10/2017
European Commission (EC) Approves EUSA Pharma’s Dinutuximab Beta For The Treatment Of Patients With High-Risk Neuroblastoma 5/10/2017
Faster FDA Approvals? Not So Fast: 1 Out of 3 New Drugs Had Safety Problems No One Knew About 5/10/2017
Novartis AG (NVS) Receives FDA Approval For First-Of-Its-Kind Kisqali Femara Co-Pack For Initial Treatment Of HR+/HER2- Advanced Or Metastatic Breast Cancer 5/9/2017
InSightec Receives FDA Approval For Exablate Neuro For 1.5T MRI In The Treatment Of Essential Tremor 5/9/2017
Mitsubishi Tanabe Wins FDA Approval for Radicava, the First New ALS Drug in 22 Years 5/8/2017
Cipher Pharma (DND.TO) Receives Health Canada Approval Of OZANEX (Ozenoxacin Cream 1%) 5/8/2017
Bovie Medical (BVX) Snags FDA Clearance for Its J-Plasma Precise Flex Handpiece 5/8/2017
Medrobotics Snags FDA Clearance for Flex Robotic System for Scarfree Colorectal Procedures 5/8/2017
Merck & Co. (MRK) Release: European Commission (EC) Approves KEYTRUDA (Pembrolizumab) For Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma Who Failed Autologous Stem Cell Transplant And Brentuximab Vedotin (BV), Or Who Are Transplant-Ineligible And Have Failed BV 5/5/2017
Crospon Nabs FDA Clearance For Endoflip With Flip Topography Module 5/5/2017
Acutus Medical Snags FDA OK for AcQGuide Steerable Sheath 5/3/2017
InterScope Technologies Wins FDA Clearance for EndoRotor, the First Flexible Shaver Technology for Interventional Gastroenterology 5/3/2017
AstraZeneca PLC (AZN) Hits Milestone With Approval of Potential Bladder Cancer Blockbuster 5/3/2017
Wowsers! FDA Approves BioMarin (BMRN)'s Brineura, the First Drug for Batten Disease 5/2/2017
BioDelivery (BDSI) Announces The Approval Of BUNAVAIL For Induction Of Buprenorphine Treatment For Opioid Dependence 5/2/2017
Teleflex Inc. (TFX) Wins FDA 510(k) Clearance for the Arrow AC3 Optimus Intra-Aortic Balloon Pump 5/2/2017
FDA Clears Faxitron's LOCalizer Radiofrequency ID System for Breast Lesion Localization 5/1/2017
Takeda (TKPYY)'s $5 Billion Bet on Ariad (ARIA) Pays Off With Accelerated Approval of Lung Cancer Med 5/1/2017
Novartis AG (NVS) Receives FDA Approval For Rydapt In Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) And Three Types Of Systemic Mastocytosis (SM) 5/1/2017
Sanofi Genzyme (SNY) Announces Approval Of Cerdelga (Eliglustat Capsules) By Health Canada For Rare Genetic Condition 5/1/2017
FDA Green Lights Medtronic (MDT)'s Resolute Onyx Drug-Eluting Stent, the First Available in 4.5 mm and 5 mm Sizes 5/1/2017
Bristol-Myers Squibb (BMY)'s Oral, Interferon-free HCV Regimen Approved In China 5/1/2017
Bristol-Myers Squibb (BMY) Release: China FDA Approves Country’s First All-Oral Regimen For Chronic Hepatitis C, Daklinza (Daclatasvir) In Combination With Sunvepra (Asunaprevir) 4/28/2017
European Commission (EC) Extends Approval For Janssen-Cilag International NV (JNJ)’s DARZALEX (Daratumumab) To Include Multiple Myeloma Patients Who Have Received At Least One Prior Therapy 4/28/2017
BioNovelus’ Enviro-Safe CR-10 Disinfectant Approved In Guatemala 4/28/2017
FDA Approves Radius Health (RDUS)’s TYMLOS (Abaloparatide), A Bone Building Agent For The Treatment Of Postmenopausal Women With Osteoporosis At High Risk For Fracture 4/28/2017
Novartis AG (NVS) Receives FDA Approval For Rydapt® In Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) And Three Types Of Systemic Mastocytosis (SM) 4/28/2017
InVivoScribe Technologies, Inc. Receives FDA Approval For The Leukostrat Cdx FLT3 Mutation Assay Companion Diagnostic Test For The Selection Of Patients For Rydapt And Is The First Companion Diagnostic For AML 4/28/2017
Bayer (BAY) Receives FDA Approval For Stivarga (Regorafenib) For The Second-Line Systemic Treatment Of Liver Cancer 4/28/2017
IMPAX Labs (IPXL) Announces FDA Approval And Launch Of A Generic Version Of Vytorin (Ezetimibe/Simvastatin Tablets) 4/27/2017
FDA Green Lights joimax's New Minimally Invasive Spine Surgery Device 4/27/2017
Novo Nordisk A/S (NVO) Receives FDA Approval Of Saxenda (Liraglutide) Injection 3 Mg Label Update Including Long-Term Safety And Efficacy Data From 3-Year Trial 4/27/2017
Reapplix ApS Release: New FDA 510(K) Clearance For Expanded System Including Automated Centrifuge 4/27/2017
Tesaro (TSRO) Announces Approval Of VARUBY (Oral Rolapitant Tablets) By European Commission (EC) 4/26/2017
Inspirion Delivery Sciences Receives FDA Approval For RoxyBond (Oxycodone Hydrochloride) Tablets CII, The First And Only Immediate Release Opioid Analgesic With Abuse-Deterrent Label Claims 4/26/2017
FDA Green Lights Allergan (AGN)'s Tear-Inducing Eye Device TrueTear 4/26/2017
Silvergate Pharmaceuticals Release: FDA Approves XATMEP, The First and Only Ready-To-Use Methotrexate Oral Solution 4/26/2017
Intuitive Surgical (ISRG) Receives CE Mark For Latest Da Vinci Robotic-Assisted Surgical System 4/26/2017
Sanofi (SNY) And Regeneron (REGN) Announce FDA Approval Of A New Once-Monthly Dosing Option For Praluent (Alirocumab) Injection 4/25/2017
Sanofi (SNY) Receives FDA Approval Of Thymoglobulin For The Prevention Of Acute Kidney Transplant Rejection 4/25/2017
Samsung Bioepis Obtains First Drug Approval In The United States, As FDA Approves RENFLEXIS (Infliximab-Abda) Across All Eligible Indications 4/24/2017
Sanofi (SNY) Receives FDA Approval Of Thymoglobulin For The Prevention Of Acute Kidney Transplant Rejection 4/24/2017
Life Spine Grabs FDA Clearance of PLATEAU-C Ti Cervical Spacer System 4/19/2017
Genentech (RHHBY)'s Advanced Bladder Cancer Drug Tecentriq Wins Accelerated Approval From the FDA 4/18/2017
FDA Clears Genentech (RHHBY)'s Lucentis For All Forms Of Diabetic Retinopathy 4/18/2017
Hoffmann-La Roche AG Release: Health Canada Approves TECENTRIQ (Atezolizumab) For Patients With Locally Advanced And Metastatic Bladder Cancer 4/18/2017
ALK-Abello A/S Release: ACARIZAX Approved In Europe For Use In Adolescent Patients With House Dust Mite-Induced Allergic Rhinitis 4/17/2017
Ivaoes Animal Health Launches New Anesthetic Product, Rapanofaltm(Propofol Emulsion Injection), The Only FDA-Approved Propofol Product Formulation Indicated For Use In Cats And Dogs 4/17/2017
Advanced Cooling Therapy Receives 510(K) Clearance From FDA For Use With New Control Unit 4/14/2017
FDA 510(k) Clearance for Entellus Medical (ENTL)’s Eustachian Tube Indication 4/13/2017
Additive Orthopaedics Announces FDA Clearance Of Their Locking Lattice Plating System For The Global Extremities Market 4/13/2017
Royal Philips Electronics N.V. (PHG) Receives FDA Clearance To Market Philips Intellisite Pathology Solution For Primary Diagnostic Use In The U.S. 4/13/2017
Sight Sciences Announces Health Canada Approval Of The VISCO 360 Viscosurgical System For Standalone Microinvasive Glaucoma Surgery (MIGS) 4/13/2017
FDA 510(k) Clearance for Ventec Life Systems’ VOCSN, the First Portable Unified Respiratory System for Patients on a Ven 4/13/2017
Nothing's Gonna Stop Neurocrine Biosciences (NBIX) Now: Shares Jumped on FDA Approval of the First and Only Drug to Treat Tardive Dyskinesia for Adults 4/13/2017
FDA Greenlights Mazor Robotics’ Spinal Deformity Correction Planning Software 4/12/2017
FDA Clears United Orthopedic Corporation’s Polyethylene Knee Insert 4/12/2017
FDA Gets Verax Biomedical Clearance for Verax PGD Test 4/11/2017
Alere (ALR) Achieves FDA Clearance for Alere Reader Platform and Alere BinaxNOW Influenza A & B Card 2 4/11/2017
FDA Finally Allows 23andMe to Sell At-Home DNA Tests for 10 Diseases 4/10/2017
Gilead (GILD) Release: FDA Approves New Indications For Harvoni And Sovaldi In Pediatric Patients 12 Years And Older With Chronic Hepatitis C Infection 4/7/2017
Supernus (SUPN) Receives Final FDA Approval For Trokendi XR For Migraine Prophylaxis In Adults And Adolescents 4/6/2017
Indian FDA Approves The First Autologous Dendritic Cell-Based Immuno-Oncology Product, APCEDEN 4/5/2017
What a Day! Genentech (RHHBY) Lands FDA Approval for First Drug to Treat Severe Multiple Sclerosis 4/4/2017
Teva (TEVA) Finally Wins FDA Approval for Potential Huntington’s Blockbuster Austedo 4/4/2017
NICO Corporation Announces CE Mark For BrainPath Non-Disruptive Cranial Access Technology 4/3/2017
ETS Wound Care Gains FDA Clearance For MIRRAGEN Advanced Wound Matrix 4/3/2017
Pfizer (PFE) Release: IBRANCE (Palbociclib) Receives FDA Regular Approval And Expanded Indication For First-Line HR+, HER2- Metastatic Breast Cancer 4/3/2017
U.S. FDA Approves Addition Of Moderate To Severe Fingernail Psoriasis Data To AbbVie (ABBV)s HUMIRA (Adalimumab) Prescribing Information 3/30/2017
Cardiovascular Systems Snags FDA Nod for Its Diamondback 360 Coronary Orbital Atherectomy System (OAS) 3/30/2017
Shire (SHPG) Release: INTUNIV (Guanfacine Hydrochloride Prolonged Release), A Non-Stimulant For The Treatment Of ADHD, Receives Approval In Japan 3/30/2017
Upsher-Smith Laboratories Release: FDA Approves Expanded Indication For Qudexy XR (Topiramate) Extended-Release Capsules To Include Prophylaxis Of Migraine Headache In Adults And Adolescents 3/30/2017
FDA Clears Massachusetts Biotech Tesaro (TSRO)'s Ovarian Cancer PARP Inhibitor 3/29/2017
Bay Area's Sonoma Pharma (OCLS) Wins FDA Clearance for Loyon Skin Descaler 3/29/2017
NuVasive (NUVA) Wins First-Ever FDA Clearance for Cervical Interbody Implant System Used in More Than Two Levels 3/29/2017
Providence Medical Technology Snags New FDA Clearances for Standalone Use of CAVUX Cervical Cage-L System and ALLY Facet Screws 3/29/2017
Sanofi (SNY) And Regeneron (REGN) Announce FDA Approval Of Dupixent (Dupilumab), The First Targeted Biologic Therapy For Adults With Moderate-To-Severe Atopic Dermatitis 3/28/2017
AstraZeneca PLC (AZN)'s Tagrisso Approved In China Following Priority Review 3/28/2017
Novo Nordisk Canada Inc. (NVO) Release: New Fast-Acting Mealtime Insulin, Fiasp, Now Approved And Available In Canada For The Treatment Of Diabetes 3/27/2017
iCAD (ICAD) Wins FDA Approval for PowerLook Tomo Detection 3/27/2017
FDA Green Lights Bovie Medical (BVX)'s Cool-Coag Generator and Open Handpiece 3/27/2017
Shionogi Release: FDA Approves Symproic (Naldemedine) Once-Daily Tablets C-II For The Treatment Of Opioid-Induced Constipation In Adults With Chronic Non-Cancer Pain 3/24/2017
Amgen (AMGN) Release: European Commission (EC) Approves Amgevita (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases 3/24/2017
EMD Serono Release: FDA Grants Approval For BAVENCIO (Avelumab), The First Immunotherapy Approved For Metastatic Merkel Cell Carcinoma 3/24/2017
Why Newron Pharma (NWRN)'s Newly Approved Parkinson's Drug Isn't All That Novel 3/23/2017
Medicure (MCU) Announces FDA Approval For Apicore LLC's Generic Tetrabenazine 3/23/2017
FDA Green Lights Medtronic (MDT)'s CoreValve Evolut Pro Transcatheter Valve With Advanced Sealing 3/22/2017
BioStable Science & Engineering Wins FDA Nod for Its HAART 300 Aortic Annuloplasty Device 3/22/2017
Newron Pharma (NWRN) Release: FDA Approves Xadago (Safinamide) For Parkinson's Disease (PD) Patients 3/22/2017
NovoCure Receives MHLW Approval For Second Generation Optune In Japan 3/20/2017
Surefire Receives Regulatory Approval For Infusion Systems And Guiding Catheters In Mexico 3/20/2017
Allergan (AGN) Release: JUVÉDERM VOLLURE XC Approved By U.S. FDA For Correction Of Facial Wrinkles And Folds In Adults Over The Age Of 21 3/20/2017
Toshiba Medical Systems’ New Premium Cardiovascular Ultrasound Wins FDA Approval 3/17/2017
Pfizer (PFE) Announces Approval By The China Food And Drug Administration Of XELJANZ, The First Oral JAK Inhibitor For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis 3/16/2017
Shire (SHPG) Receives European Approval For Label Extension Of CINRYZE (C1 Inhibitor [Human]) To Prevent And Treat Hereditary Angioedema (HAE) Attacks In Paediatric Patients With HAE 3/16/2017
DJO Global (DJO) Grabs FDA Nod for Exprt Revision Hip 3/15/2017
Pfizer (PFE) Looks Over Its Shoulder as Novartis AG (NVS) Grabs a Quick Approval for Breast Cancer Drug 3/14/2017
Cambridge-based Astex Pharma (ASTX) Celebrates As Cancer Drug Receives US Marketing Approval 3/14/2017
FDA Clears Teleflex Inc. (TFX)'s Spectre Guidewire 3/14/2017
Teleflex Inc. (TFX) Wins FDA Approval of Its Twin-Pass Torque Dual Access Catheter 3/14/2017
Medtronic (MDT) Snags FDA Approval for First of Its Kind Melody Transcatheter Pulmonary Valve 3/14/2017
FDA OKs Medtronic (MDT)'s New Kyphon Xpede Bone Cement 3/14/2017
BioQ Receives Australian Regulatory Approval For Ropivacaine ReadyFusOR 3/14/2017
Ipsen (IPN.PA) Announces Health Canada Approval Of DYSPORT THERAPEUTIC (Abobotulinumtoxina) For The Treatment Of Patients With Cervical Dystonia And Adult Upper Limb Spasticity 3/14/2017
Ipsen (IPN.PA) Announces MHRA1 Approval Of New Indication For Decapeptyl For The Treatment Of Pre-Menopausal Women With Early Stage Breast Cancer 3/13/2017
Medtronic (MDT) Nabs FDA Nod for Reveal LINQ Insertable Cardiac Monitor With TruRhythm Detection 3/13/2017
PQ Bypass Wins CE Mark for DETOUR Percutaneous Bypass Technologies 3/13/2017
FDA OKs Expanded Approval of Spineology Inc.'s Elite Expandable Interbody Fusion System 3/13/2017
Clinigen Release: First-In-Class Fycompa (Perampanel) Approved In South Africa For Partial-Onset Seizures 3/10/2017
Osprey Med Nabs FDA Nod for DyeVert 3/9/2017
Teligent Announces FDA Approval Of Clobetasol Propionate Gel, 0.05% 3/8/2017
FDA Approves Serenity’s Noctiva (Desmopressin Acetate) – The First Drug Approved For The Treatment Of Nocturia 3/7/2017
Swedish Orphan AB - FDA Approves In-Use Storage At Room Temperature For Orfadin Capsules 3/7/2017
Nephros (NEP) Snags FDA Clearance of EndoPur Endotoxin 10" Filter 3/6/2017
BioCad: The First Ever Biosimilar Of Interferon Beta-1a Approved In Russia 3/6/2017
Tryton Medical Wins FDA Nod for Tryton Side Branch Stent to Treat Significant Coronary Bifurcation Lesions 3/6/2017
Teligent Announces FDA Approval Of Triamcinolone Acetonide Ointment USP, 0.5% 3/6/2017
Sobi Release: FDA Approves Increased Shelf Life And In-Use Storage At Room Temperature For Orfadin (nitisinone) 3/6/2017
Serenity Release: FDA Approves First Treatment For Frequent Urination At Night Due To Overproduction Of Urine 3/3/2017
Amend Surgical Wins FDA Nod for NanoFUSE BA 3/2/2017
Sobi Receives Approval From The EMA For Higher Capacity Drug Substance Manufacturing For Elocta 3/2/2017
FDA Approves Neocis' First Robotic System for Dental Implant Procedures 3/2/2017
Akorn, Inc. (AKN) Receives FDA Approval For Ephedrine Sulfate Injection, USP 3/2/2017
FDA Says Yes to Lexicon Pharma (LXRX)'s Carcinoid Syndrome Diarrhea Drug, Stock Soars 3/1/2017
Perrigo (PRGO) Announces FDA Final Approval For The Generic Version Of Axiron Topical Solution, 30 mg/1.5 mL 3/1/2017
FDA Green Lights CeloNova Biosciences' COBRA PzF Stent System 3/1/2017
Akorn, Inc. (AKN) Receives Approval For Mycophenolate Mofetil For Injection, USP 3/1/2017
AstraZeneca PLC (AZN) Release: FDA Approves Once-Daily QTERN (Dapagliflozin And Saxagliptin) Tablets For Adults With Type-2 Diabetes 2/28/2017
Scopis GmbH Wins FDA Clearance for Cutting-Edge ENT Surgery Navigation System 2/28/2017
Chugai Pharma's ALK Inhibitor "Alecensa" Approved In Taiwan 2/27/2017
BTG plc (BTG.L) Snags FDA Clearance for Blood Clot Device EKOS Control Unit 4.0 2/27/2017
Bracco Diagnostics Receives U.S. FDA Approval For VARIBAR PUDDING (Barium Sulfate) Oral Paste For Fluoroscopy 2/27/2017
OWC Pharmaceutical Research Corp. Receives IRB Approval To Initiate Safety Testing On Its Cannabinoid-Infused Cream For Treatment Of Psoriasis 2/27/2017
FDA Green Lights Cagent Vascular's Next Generation Vessel Dilatation Device 2/27/2017
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



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