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Clinical - Approvals
Eli Lilly (LLY)'s New Cancer Drug Portrazza Wins FDA Approval 11/25/2015
XENIOS AG Grabs CE Mark for Its i-cor Synchronized Cardiac Assist System 11/25/2015
FDA Approves Emergent BioSolutions (EBS)' BioThrax For Post-Exposure Prophylaxis 11/25/2015
Seqirus Receives FDA Approval For FLUAD (Influenza Vaccine, Adjuvanted) For Adults Aged 65 Years And Older 11/25/2015
Exelixis (EXEL) Announces European Commission (EC) Approval Of COTELLIC (Cobimetinib) For Use In Combination With Vemurafenib In Advanced BRAF V600 Mutation-Positive Melanoma 11/25/2015
Roche (RHHBY) Receives EU Approval Of Cotellic For Use In Combination With Zelboraf In Advanced Melanoma 11/25/2015
Pfizer (PFE) Receives European Approval To Expand Use Of XALKORI(Crizotinib) To First-Line Treatment Of Adults With ALK-Positive Advanced Non-Small Cell Lung Cancer 11/25/2015
Swedish Orphan Biovitrum And Biogen (BIIB)’s ELOCTA (rFVIIIFc) Approved In Europe For The Treatment Of Haemophilia A 11/24/2015
Bristol-Myers Squibb (BMY) Announces U.S. FDA Approval For Opdivo (Nivolumab) As A Single Agent For The Treatment Of Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma 11/24/2015
Bristol-Myers Squibb (BMY) Receives FDA Approval For Opdivo (Nivolumab), The Only Treatment To Deliver Significant Overall Survival In Advanced Renal Cell Carcinoma Vs. A Standard Of Care, In Patients Who Have Received Prior Anti-Angiogenic Therapy1 11/24/2015
Entellus Medical (ENTL) Snags FDA Approval for XprESS Multi-Sinus Dilation System in Pediatric Patients 11/24/2015
European Commission (EC) Approves Amgen (AMGN)'s BLINCYTO (blinatumomab) For The Treatment Of Adults With Philadelphia Chromosome-Negative Relapsed Or Refractory B-Precursor Acute Lymphoblastic Leukemia 11/24/2015
Debiopharm's Partner Yakult Honsha Announces Elplat Approbation In Gastric Cancer In Japan 11/24/2015
FDA Grants Full U.S. Approval for Novartis AG (NVS)' Targeted Skin Cancer Combo 11/23/2015
Boehringer Ingelheim Release: FDA Approves Pradaxa (dabigatran etexilate mesylate) For Prophylaxis Of Deep Venous Thrombosis (DVT) And Pulmonary Embolism (PE) After Hip Replacement Surgery 11/23/2015
Adding Multimedia U.S. FDA Approves Takeda (TKPYY)’s Ninlaro(Ixazomib), The First And Only Oral Proteasome Inhibitor To Treat Multiple Myeloma 11/23/2015
Cumberland Pharmaceuticals (CPIX) Release: Caldolor Approved For Use In Pediatric Patients 11/23/2015
Samsung Bioepis, Biogen (BIIB) Biosimilar is About to Take a Huge Chunk of Pfizer (PFE)'s Profits 11/20/2015
Boston Scientific (BSX) Grabs CE Mark For Next Generation WATCHMAN FLX Left Atrial Appendage Closure Device 11/20/2015
Breckenridge Pharmaceutical, Inc. Announces Final Approval For Dutasteride Soft Gelatin Capsules 11/20/2015
Amgen (AMGN) Release: European Commission Approves Kyprolis (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma 11/20/2015
FDA Approves Takeda (TKPYY)'s Ixazomib for Multiple Myeloma 11/20/2015
Vertex (VRTX) Receives EU 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 11/20/2015
The Medicines Company (MDCO) Receives European Commission (EC) Approval For IONSYS 40 Micrograms Per Dose Transdermal System (Fentanyl) To Treat Post-Operative Pain In Adult Hospitalized Patients 11/20/2015
Acerus Reports Approval Of ESTRACE Generic In Canada 11/20/2015
Visunex Medical Wins FDA Approval for Revolutionary Imaging Device for Vision Screening of All Newborn Infants 11/19/2015
St. Jude Medical (STJ) Announces FDA Approval Of The Proclaim Elite SCS System, A Patient-Centric, Recharge-Free, Upgradeable And MR-Conditional Chronic Pain Treatment Option 11/19/2015
Breckenridge Pharmaceutical, Inc. Announces Approval For Rabeprazole Sodium Delayed-Release Tablets 11/19/2015
Vertex (VRTX) Receives Two EU Approvals For KALYDECO (ivacaftor) For People With Cystic Fibrosis 11/18/2015
Protein Sciences Corporation Release: Flublok Influenza Vaccine Approved In Mexico 11/18/2015
Moximed Wins CE Mark and First Commercial Use of AtlasTM Knee System 11/18/2015
Johnson & Johnson (JNJ) Snags Early Approval for Breakthrough Multiple Myeloma Drug Darzalex 11/17/2015
Medtronic (MDT) Wins FDA Nod and Launches World's First App-Based Remote Monitoring System for Pacemakers 11/17/2015
Swedish Orphan Biovitrum Release: European Medicines Agency Approves Xiapex For Concurrent Treatment Of Palpable Cords 11/17/2015
Patent Approval For BiondVax Pharmaceuticals: BiondVax Receives Approval For Patent In Korea For Its Universal Flu Vaccine 11/17/2015
Genmab A/S (GEN.CO) Announces FDA Approval Of DARZALEX (Daratumumab) For Multiple Myeloma And Updates Financial Guidance 11/17/2015
Vigilant Biosciences Snags CE Mark for OncAlert Oral Cancer CD44/Total Protein LAB Test to Aid in Diagnosis of Oral Cancer 11/16/2015
FDA Approves Gilead (GILD)'s Harvoni for Expanded Use 11/13/2015
Spectranetics (SPNC) Wins FDA Approval of Turbo-Power Laser Atherectomy Catheter 11/13/2015
AstraZeneca PLC (AZN) Release: TAGRISSO (osimertinib) (AZD9291) Approved By The US FDA As Treatment For Patients With EGFR T790M Mutation-Positive Metastatic Non-Small Cell Lung Cancer 11/13/2015
Newron Pharmaceuticals (NWRN) And Zambon Release: Swissmedic Approves Xadago (Safinamide) For Use In Parkinson’s Disease 11/13/2015
Baxalta (BXLT) Gains EU Marketing Authorization To Provide OBIZUR To Adult Patients With Acquired Hemophilia A 11/13/2015
FDA Approves Daiichi Sankyo, Plexxikon's Cobimetinib In Combination With Zelboraf for Advanced Melanoma Patients 11/11/2015
Perrigo (PRGO) Announces FDA Approval Of The AB Rated Generic Version Of KlorCon Extended-Release Tablets 11/10/2015
FDA Green Lights Exelixis (EXEL)-Genentech (RHHBY)'s Vemurafenib/Cobimetinib Combo for Melanoma 11/10/2015
SI-BONE's iFuse Implant System Receives Indication Cleared by the FDA 11/9/2015
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Announce First European Marketing Approval Of RIZAPORT (RHB-103) For Migraines 11/9/2015
EDAP TMS (EDAP) Snags FDA Approval for Ablatherm HIFU 11/9/2015
Syneron Candela Snags New FDA Approval for the CO2RE System 11/5/2015
Convergent Dental Wins FDA Clearance of Osseous Tissue Procedures for Solea 11/5/2015
FDA Approves Gilead (GILD)’s Single Tablet Regimen Genvoya (Elvitegravir, Cobicistat, Emtricitabine And Tenofovir Alafenamide) For Treatment Of HIV-1 Infection 11/5/2015
FDA Green Lights GlaxoSmithKline (GSK)'s Nucala for Severe Asthma 11/5/2015
Akers Biosciences, Inc.' Flagship Test For Heparin-Induced Thrombocytopenia Granted Approval By Chinese Food And Drug Administration 11/4/2015
Reflexion Health Digital Medicine Therapy Tool, Vera, Receives FDA 510(K) Clearance 11/4/2015
Implanet Release: ANVISA Regulatory Approval Granted In Brazil To Market The JAZZ Band Platform 11/3/2015
Anika Therapeutics (ANIK) Announces Health Canada Approval Of CINGAL For The Treatment Of Pain Associated With Osteoarthritis Of The Knee 11/3/2015
Mallinckrodt (MNK)'s INOmax Approved In Australia And Japan For Pulmonary Hypertension In Conjunction With Heart Surgery 10/30/2015
Regeneron (REGN) Announces EU Approval Of EYLEA (Aflibercept) Injection For The Treatment Of Visual Impairment Secondary To Myopic Choroidal Neovascularization 10/30/2015
Integra LifeSciences (IART) Wins Expanded Indication for CUSA Excel+ System for Liver Surgery 10/30/2015
Celgene (CELG)’s VIDAZA (Azacitidine For Injection) Approved By European Commission (EC) As New Treatment For Elderly Patients With Acute Myeloid Leukaemia 10/30/2015
FDA Approves Novartis AG (NVS)'s Dual Combination Bronchodilator for COPD 10/30/2015
Investors Elated as Amgen (AMGN) Wins FDA Approval for First-of-Its-Kind Cancer Killing Virus Drug 10/30/2015
Bristol-Myers Squibb (BMY) Receives Approval From FDA For Yervoy (Ipilimumab) As Adjuvant Treatment For Fully Resected Stage III Melanoma 10/29/2015
Mundipharma AG Release: Green Whistle Receives Regulatorry And Marketing Approval In The United Kingdom 10/28/2015
AV Medical Tech Snags FDA Approval for its Chameleon Angioplasty Balloon Catheter 10/27/2015
Thermo Fisher Scientific (TMO) Release: New Immunoassay For The Specific Detection Of Hydrocodone Receives FDA 510 (K) Clearance 10/27/2015
Masimo (MASI) Announces FDA 510(K) Clearance For Mightysat Rx Fingertip Pulse Oximeter 10/27/2015
BioDelivery (BDSI)'s BELBUCA Wins FDA Approval, Triggers $50 Million Milestone Payment from Endo Pharma (ENDP) 10/26/2015
Endo Pharma (ENDP) Release: U.S. FDA Approves BELBUCA (buprenorphine) Buccal Film For Chronic Pain Management 10/26/2015
Sinovac Biotech Ltd. (SVA) Receives Clinical Trial Approval For Varicella Vaccine Candidate 10/26/2015
FDA Green Lights Alexion (ALXN)'s Metabolic Disorder Drug Strensiq 10/26/2015
Iroko Pharmaceuticals Receives FDA Approval For VIVLODEX - First Low Dose SoluMatrix Meloxicam For Osteoarthritis Pain 10/23/2015
Merrimack (MACK) Announces U.S. FDA Approval Of ONIVYDE (Irinotecan Liposome Injection) For The Treatment Of Patients With Metastatic Pancreatic Cancer 10/23/2015
Janssen Biotech Inc. (JNJ) Release: U.S. FDA Approves YONDELIS (trabectedin) For The Treatment Of Patients With Unresectable Or Metastatic Liposarcoma Or Leiomyosarcoma, Two Common Subtypes Of Soft Tissue Sarcoma 10/23/2015
C2 Therapeutics' Wins CE Mark for Novel Cryoablation Device 10/22/2015
PharmaEngine, Inc. Announces Taiwan FDA Approval of ONIVYDE (irinotecan liposome injection) For The Treatment Of Metastatic Pancreatic Cancer 10/22/2015
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of Intuniv (Guanfacine) Extended-Release Tablets, 1 mg, 2 mg, 3 mg And 4 mg 10/22/2015
Relypsa (RLYP) Announces FDA Approval Of Veltass (Patiromer) For Oral Suspension For The Treatment Of Hyperkalemia 10/22/2015
Bio Products Laboratory Receives FDA Approval For Coagadex (Coagulation Factor X, Human) 10/21/2015
Argentina's Ministry Of Health Approves MediWound (MDWD)'s NexoBrid 10/20/2015
Tris Pharma, Inc. Receives FDA Approval Of Dyanavel XR (amphetamine) CII As Once-Daily Liquid For Treatment Of ADHD In Children 10/20/2015
Sensus Healthcare Receives FDA 510k Clearance For Next Generation Image Guided Superficial Radiotherapy SRT-100 Vision 10/19/2015
LEO Pharma Announces FDA Approval Of Enstilar(Calcipotriene And Betamethasone Dipropionate) Foam, 0.005%/0.064% For Plaque Psoriasis 10/19/2015
FDA Green Lights Boehringer Ingelheim's Blood Thinner Reversal Agent Praxbind 10/19/2015
Swedish Orphan Biovitrum Release: Xiapex Approved For The Treatment Of Peyronie's Disease In Switzerland 10/16/2015
Baxalta (BXLT) Gains Health Canada Approval For OBIZUR To Treat Patients With Acquired Hemophilia A 10/15/2015
BioDelivery Sciences International (BDSI) Announces FDA Approval Of Change In BUNAVAIL Product Specification Allowing For Immediate Release Of Product 10/15/2015
Avinger Nabs FDA 510(k) Clearance for Pantheris 10/15/2015
Lannett (LCI) Receives FDA Approval For Memantine Hydrochloride Oral Solution, 2 mg/mL 10/14/2015
APR Applied Pharma Research S.A. (APR) Announces The European Class III CE Mark Approval Of Nexodyn Acidoxidizing Solution (AOS) For The Management Of Acute And Chronic Wounds 10/14/2015
PharmaRoth Labs Announces Approval Of Sucanon In Canada 10/14/2015
Baxter International (BAX) Announces FDA Clearance For AMIA Automated Peritoneal Dialysis System With SHARESOURCE Connectivity Platform 10/13/2015
Safe Orthopaedics Obtains FDA Approval To Market Its Unique Implant For Spinal Trauma Care In The United States 10/13/2015
NuVasive (NUVA) Wins First Ever FDA 510(k) Clearance of Cervical Corpectomy Cage 10/12/2015
Endologix Announces FDA Approval Of AFX2 Bifurcated Endograft System 10/12/2015
Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab) Receives Expanded FDA Approval In Previously-Treated Metastatic Non-Small Cell Lung Cancer (NSCLC), Offering Improved Survival To More Patients 10/12/2015
NovoCure Release: FDA Approves Optune In Combination With Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma 10/9/2015
SentreHEART Receives CE Mark Approval For The LARIAT Surgical Left Atrial Appendage Suture Delivery Device 10/8/2015
Carestream Health Obtains FDA Clearance For Diagnostic Reading Of ECG Waveforms On Mobile Tablets Using Vue Motion Viewer 10/8/2015
Marrone Bio Innovations, Inc Receives EPA Approval For MAJESTENE Bionematicide 10/8/2015
Teva (TEVA) Announces Approval Of Three-Times-A-Week COPAXONE 40 Mg/Ml In Russia For The Treatment Of Relapsing-Remitting Multiple Sclerosis 10/8/2015
Avita Medical Snags CE Mark for ReGenerCell and ReNovaCell to Complete Skin Healing Portfolio 10/7/2015
LONSURF (Trifluridine And Tipiracil) Approved For Refractory Metastatic Colorectal Cancer, Available At Biologics, Inc. (NC) 10/7/2015
FDA Green Lights Alkermes (ALKS)' Schizophrenia Treatment Aristada 10/7/2015
Gilead (GILD) Scores FDA Approval of Letairis Combo as PAH Treatment 10/6/2015
McGuff Pharmaceuticals, Inc. Announces FDA Approval For Hydroxyprogesterone Caproate Injection, USP (HPC). 10/6/2015
FDA Clears Corindus Vascular Robotics's CorPath System for Robotic-assisted Radial Access PCI Procedures 10/6/2015
Hitachi Medical Systems America Announces FDA Clearance of High-Value Supria 16-Slice CT System 10/6/2015
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of DIABETA (Glyburide) Tablets, USP, 1.25 Mg, 2.5 Mg, And 5 Mg 10/5/2015
NovoCure Grabs CE Mark and First Patient Use of Second Generation Optune System 10/5/2015
Dako (A) Snags FDA Approval of New Companion Diagnostic for Lung Cancer 10/5/2015
Bay Area's EBR Systems Wins CE Mark Approval for World’s First Wireless Cardiac Pacing System for Heart Failure 10/5/2015
Inspirion Delivery Technologies Receives FDA Approval For MorphaBond (morphine sulfate) Extended-Release Tablets CII, An Opioid Analgesic Formulated With Abuse-Deterrent Properties 10/5/2015
Irvine Scientific Receives CE Mark Approval For Human Serum Albumin 10/5/2015
InspireMD Ltd. Announces CGuard Approval In Columbia 10/5/2015
FDA Green Lights Merck & Co. (MRK)'s’s Keytruda for Most Common Form of Lung Cancer 10/2/2015
FDA Green Lights Bristol-Myers Squibb (BMY)'s Drug Combo for Metastatic Melanoma 10/2/2015
Allergan (AGN) Release: U.S. FDA Approves JUVEDERM ULTRA XC For Use In Lips 10/1/2015
SpineGuard Receives CE Mark For New Application Of Its Disruptive DSG (Dynamic Surgical Guidance) Platform 9/30/2015
As Spinoff Rumors Spin, Sanofi (SNY)’s Cholesterol Drug Praluent Gets Approval in Europe 9/29/2015
UVLrx Therapeutics Wins CE Marking for Intravenous UV Light Therapy Device 9/29/2015
Novo Nordisk A/S (NVO) Finally Bags Diabetes Drug Tresiba U.S. Approval 9/28/2015
AbbVie (ABBV)'s VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval In Japan For The Treatment Of Genotype 1 Chronic Hepatitis C 9/28/2015
Merck & Co. (MRK)'s Once-Weekly Diabetes drug MARIZEV Approved in Japan 9/28/2015
Enanta Pharmaceuticals, Inc. Announces Approval Of VIEKIRAX (Ombitasvir/Paritaprevir/Ritonavir Tablets) In Japan For The Treatment Of Genotype 1 Chronic Hepatitis C 9/28/2015
Teva (TEVA) Announces Approval Of COPAXONE In Japan For The Prevention Of Relapse Of Multiple Sclerosis 9/28/2015
Takeda Pharmaceutical Co. Ltd. (TKPYY): New Drug Application Approval In Japan For Copaxone Subcutaneous Injection 20 Mg Syringe, A Drug For The Treatment Of Multiple Sclerosis 9/28/2015
Keryx (KERX) Receives European Approval For Fexeric (Ferric Citrate Coordination Complex) For The Treatment Of Hyperphosphatemia In Adults With Chronic Kidney Disease 9/24/2015
Medical Developments International Limited Release: Green Whistle Receives Regulatory Approval In Singapore 9/24/2015
Starpharma Release: EU Marketing Approval Granted For VivaGel BV 9/24/2015
Camber Pharma Launches Generic Nexium Delayed-Release Capsules 9/24/2015
B. Braun Medical Receives FDA Clearance for Infusomat Space Pump 9/23/2015
Implanet: New JAZZ Band FDA Clearance Expands Posterior Fixation System Selection 9/23/2015
Taiho Oncology Announces FDA Approval Of LONSURF (Trifluridine And Tipiracil) For Refractory Metastatic Colorectal Cancer (mCRC) 9/23/2015
VolitionRX Wins First CE Mark for NuQ Blood Assay for Colorectal Cancer Detection 9/22/2015
Ceterix Orthopaedics Wins FDA Approval for Next-Gen Meniscus Repair Device 9/22/2015
St. Jude Medical (STJ) Grabs CE Mark for the New Infinity Deep Brain Stimulation System and Directional DBS Lead 9/22/2015
Bayer (BAY) Introduces New Single-Dose Treatment For Canine Otitis Externa 9/22/2015
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of Testred C-III (Methyltestosterone Capsules, USP), 10 Mg 9/22/2015
Perrigo (PRGO) Announces FDA Approval And Launch Of The AB Rated Generic Version Of Benzaclin Topical Gel 9/22/2015
Shire (SHPG) Receives European Approval For INTUNIV (Guanfacine) Hydrochloride Prolonged Release Tablets) As A Non-Stimulant ADHD Treatment For Children And Adolescents 9/21/2015
Eli Lilly (LLY) Release: New Gastric Cancer Medicine Approved And Available For Use In Canada 9/21/2015
Specialised Therapeutics Australia' Breakthrough Brain Tumour Visualisation Drug GLIOLAN Approved For Use In New Zealand 9/18/2015
Full Product Approval In Japan Received By Mesoblast (MSB.AX) Licensee 9/18/2015
FDA Approves Allergan (AGN) and Gedeon Richter (RIG2.F)'s Antipsychotic Vraylar 9/18/2015
IMPAX Labs (IPXL) Receives FDA Approval For Generic Version Of Mestinon Timespan Tablets, 180 Mg 9/17/2015
FDA Green Lights Octapharma USA's NUWIQ for Hemophilia A 9/15/2015
Health Canada Approves Amgen (AMGN)'s New Cholesterol-Lowering Medication Repatha (evolocumab) 9/15/2015
AbbVie (ABBV) Snags Another Win for Humira 9/14/2015
Allergan (AGN) And Perrigo (PRGO) Receive FDA Approval Of Three Extended Release Products Equivalent To Mucinex And Mucinex DM 9/11/2015
Xtant Medical Announces FDA Clearance of the Aranax Cervical Plate 9/9/2015
BioLineRx Ltd.’s Novel Treatment For Non-Surgical Removal Of Skin Lesions Submitted For CE Mark Registration 9/9/2015
Thermo Fisher Scientific (TMO) Receives IVDD CE Mark for its Thermo Scientific Prelude MD HPLC, Endura MD Mass Spectrometer and ClinQuan MD Software 9/8/2015
Nanosphere Grabs FDA Approval for First-of-Its-Kind Flexible Respiratory Pathogens Test 9/8/2015
New Haven Pharmaceuticals Receives FDA Approval For DURLAZA (Aspirin) Extended Release Capsules For Secondary Prevention Of Stroke And Acute Cardiac Events 9/8/2015
Merck & Co. (MRK) And Samsung Bioepis Announce Approval Of BRENZYS (Etanercept), A Biosimilar Of Enbrel, In Korea 9/8/2015
Wellstat Therapeutics Corporation Announces FDA Approval Of XURIDEN To Treat Rare Pediatric Disorder Hereditary Orotic Aciduria (HOA) 9/8/2015
AstraZeneca PLC (AZN) Wins FDA Green Light for Long-Term Brilinta Use in U.S. 9/4/2015
Teleflex Incorporated (TFX) Snags FDA Nod for the ARROW® Triple Lumen Pressure Injectable Acute Hemodialysis Catheter 9/3/2015
Salutaris Medical Devices Announces 510(k) Clearance 9/3/2015
Sandoz Canada Release: Health Canada Approves New Indications For Promnitrope (Somatropin), Canada's First Subsequent Entry Biologic (Biosimilar) 9/3/2015
Allergan (AGN) Announces FDA Approval Of Updated Label For TEFLARO (ceftaroline fosamil) 9/2/2015
Wright Medical Group (WMGI) Wins FDA Approval for AUGMENT Bone Graft 9/2/2015
Merck & Co. (MRK) Release: FDA Approves Pediatric Indication For EMEND (Aprepitant) Capsules In Combination With Other Antiemetic Agents 9/2/2015
Ligand (LGND) Release: Revolade Receives EU Approval As First-In-Class Therapy For Patients With Severe Aplastic Anemia 9/2/2015
Janssen Biotech Inc. (JNJ) Release: U.S. FDA Approves Update Of SIMPONI ARIA (golimumab for infusion) Label To Include Improvement In Both Physical And Emotional Measures Of Health When Treating Moderately To Severely Active Rheumatoid Arthritis 9/2/2015
Tesaro (TSRO) Wins FDA Nod for Chemotherapy-Induced Nausea Drug Varubi 9/2/2015
Surefire Wins FDA Approval for Precision Direct-to-Tumor Embolization Device 9/1/2015
Alexion (ALXN) Release: European Commission Grants Marketing Authorization For Strensiq (Asfotase Alfa) For The Treatment Of Patients With Pediatric-Onset Hypophosphatasia (HPP) 9/1/2015
Alexion (ALXN) Release: European Commission Grants Marketing Authorization For Kanuma (Sebelipase Alfa) For The Treatment Of Patients Of All Ages With Lysosomal Acid Lipase Deficiency (LAL-D) 9/1/2015
ZEISS Sets The Pace In OCT Innovation With First FDA 510(K) Clearance Of OCT Angiography Technology 9/1/2015
FDA Approval of Amgen (AMGN)’s Cholesterol Drug Repatha Could Boost Job Growth on East Coast 9/1/2015
Sunovion Pharmaceuticals Inc. Announces FDA Approval Of A New Indication For Aptiom (Eslicarbazepine Acetate) As Monotherapy For Partial-Onset Seizures 8/31/2015
MagVenture's Major Depressive Disorder Therapy System Wins FDA Approval 8/28/2015
FDA Approves Amgen (AMGN)'s New Cholesterol-Lowering Medication Repatha (evolocumab) 8/28/2015
Sunovion Pharmaceuticals Inc. Announces FDA Approval Of A New Indication For Aptiom (Eslicarbazepine Acetate) As Monotherapy For Partial-Onset Seizures 8/28/2015
Exelixis (EXEL) Announces First Regulatory Approval Of Cobimetinib In Switzerland 8/27/2015
Boehringer Ingelheim Release: U.S. FDA Approves Synjardy (empagliflozin/metformin hydrochloride) Tablets For Adults With Type 2 Diabetes 8/27/2015
Bacterin's Xtant Medical Wins FDA Approval of OsteoSelect PLUS 8/25/2015
Ligand (LGND) Release: FDA Expands Use Of Promacta To Include Treatment Of Children Ages 1 And Older With Chronic Immune Thrombocytopenia 8/25/2015
FDA Approves Expanded Use of Promacta for Novartis AG (NVS) 8/25/2015
St. Jude Medical (STJ) Wins CE Mark for Prodigy MRI with Select Leads 8/24/2015
FDA Green Lights Boston Scientific (BSX)'s Innova Stent for Peripheral Artery Disease 8/20/2015
Sprout's First-Ever Female Libido Drug Comes With Boxed Warning and Controversy 8/20/2015
Sprout Receives FDA Approval of ADDYI (Flibanserin 100 MG) 8/19/2015
Swedish Orphan Biovitrum Release: Kineret Receives Australian Regulatory Approval For Use In Systemic Juvenile Idiopathic Arthritis 8/19/2015
Sprout to Expand to 200 Employees After FDA Approval of Female Sex-Drive Drug 8/19/2015
Lannett (LCI) Receives FDA Approval, Launches Generic Antidepressant Drug ABILIFY 8/18/2015
Aurora Spine Wins CE Mark Approval for Sterile-Packed TiNano Coated Interbody Systems 8/18/2015
Seattle Genetics (SGEN) Announces FDA Regular Approval Of ADCETRIS (Brentuximab Vedotin) For Classical Hodgkin Lymphoma Patients At High Risk Of Relapse Or Progression As Post-Autologous Hematopoietic Stem Cell Transplantation Consolidation 8/18/2015
Raptor Pharmaceutical Inc. (RPTP) Receives FDA Approval Of Expanded Label For PROCYSBI To Treat Children Aged 2-6 Years With Nephropathic Cystinosis 8/17/2015
GE Healthcare First to Win FDA Approval for Low Dose CT Lung Cancer Screening 8/17/2015
Alexion Pharma Canada Release: Health Canada Approves Strensiq (asfotase alfa), The First Therapy For Patients With Hypophosphatasia (HPP), An Ultra-Rare, Life-Threatening Disease 8/17/2015
Baxter International (BAX) And Water Street Announce FDA Approval Of CEFAZOLIN 2 Gram Premix 8/14/2015
BioDelivery Sciences International (BDSI) Announces FDA Approval Of New Formulation Of ONSOLIS (fentanyl buccal soluble film) CII 8/13/2015
Octapharma USA, Inc.: FDA Approves WILATE License Supplement – Perioperative Management Of Bleeding In Patients With Von Willebrand Disease 8/13/2015
Biogen Canada Inc. Release: Health Canada Approves PLEGRIDY (peginterferon beta-1a) For Adults With Relapsing Remitting Multiple Sclerosis 8/13/2015
Apollo Endosurgery's Gastric Balloon for Obesity Wins FDA Approval 8/12/2015
Uptake Medical Receives CE Mark Approval For InterVapor Targeted Ablation Therapy For Severe Emphysema 8/12/2015
Orexo AB (ORXOF) Wins FDA Approval for ZUBSOLV 8/11/2015