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Clinical - Approvals
GlaxoSmithKline (GSK) Receives FDA Approval For A New Self-Injectable Formulation Of Benlysta (Belimumab) For Systemic Lupus Erythematosus 7/24/2017
Teleflex Inc. (TFX)'s Arrow Seldinger Arterial Catheterization Device Nabs FDA Market Clearance 7/24/2017
Bristol-Myers Squibb (BMY) Release: FDA Expands Approval Of Yervoy (Ipilimumab) To Include Pediatric Patients 12 Years And Older With Unresectable Or Metastatic Melanoma 7/24/2017
SillaJen And Lee's Pharmaceutical Announce Approval By The China CFDA To Commence Phase III Clinical Trial For Oncolytic Immunotherapy, Pexa-Vec, In Liver Cancer 7/21/2017
Teligent Announces FDA Approval Of Erythromycin Topical Gel USP, 2% 7/21/2017
Aspect Imaging Wins FDA Approval for the First Neonatal Magnetic Resonance Imaging Device 7/21/2017
BioLogics Release: NERLYNX (Neratinib) Tablets Approved For HER2+ Breast Cancer In The Extended Adjuvant Setting 7/21/2017
Relypsa (RLYP) Announces European Approval Of Veltassa To Treat Adult Patients With Hyperkalemia (Elevated Blood Potassium Levels) 7/21/2017
Vifor Pharma Release: European Commission (EC) Approves Marketing Authorisation For Veltassa 7/21/2017
Sunovion’s Latuda (Lurasidone HCI) Receives Health Canada Approval To Treat Adolescents With Schizophrenia 7/21/2017
FDA Green Lights Gilead (GILD)'s Vosevi, With a Black Box Warning Attached 7/20/2017
Alcresta Snags FDA 510(K) Clearance for Use Of Relizorb in Kids 7/20/2017
Masimo (MASI) Grabs CE Marking of Noninvasive RPVi 7/20/2017
Innovus Pharma’s Partner Luminarie Receives Approval For Zestra For Female Sexual Arousal Disorder As A Medical Device I From Australia’s Therapeutic Goods Administration 7/20/2017
Puma Biotech (PBYI) Surges After the FDA Officially Approves Breast Cancer Drug 7/19/2017
Becton, Dickinson and Company (BDX) Wins FDA 510(k) Clearance for New Immunological Diagnostic System 7/19/2017
Perrigo (PRGO) Announces FDA Final Approval For Its AB Rated Generic Version Of DermOtic Oil, 0.01% Ear Drops 7/19/2017
Recordati: The European Commission (EC) Approves Reagila (Cariprazine) For The Treatment Of Schizophrenia 7/19/2017
Ascentage Pharma Approved To Start China Trial Of Apoptosis Drug 7/19/2017
T2 Biosystems (TTOO) Receives CE Mark For T2Bacteria Panel Enabling Commercialization In Europe 7/18/2017
IMPAX Labs (IPXL) Announces FDA Approval Of Its AB Rated Generic Concerta (Methylphenidate Hydrochloride) Extended-Release Tablets CII 7/17/2017
Cardiome Pharma Corp. (COM.TO) Announces Health Canada Approval Of AGGRASTAT High Dose Bolus Regimen 7/17/2017
Perrigo (PRGO) Announces FDA Final Approval For Its First-To-File Ab Rated Generic Version Of Androgel Topical Gel, 1.62% Packets 7/17/2017
People's Republic Of China Approves Proliant Biologicals For The Importation Of New Zealand BSA 7/17/2017
FDA Gives Nod to Johnson & Johnson (JNJ)'s Potential Blockbuster Psoriasis Med 7/17/2017
Lannett (LCI) Receives Approval For Cyproheptadine Hydrochloride Syrup, 2 mg/5 mL 7/14/2017
BioLife Solutions, Inc. (BLFS.OB) CryoStor Cell Freeze Media Embedded In Invossa: First Approved Cell And Gene Therapy For Osteoarthritis 7/14/2017
Great Basin Scientific Wins FDA 510(k) Clearance for Stool Bacterial Pathogens Panel 7/14/2017
TissueGene, Inc. Release: Korea Approves The World's First Cell And Gene Therapy For Knee Osteoarthritis 7/12/2017
FDA Clears Oventus' O2Vent W 7/12/2017
Amgen (AMGN) Release: FDA Grants Full Approval For BLINCYTO (Blinatumomab) To Treat Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia In Adults And Children 7/12/2017
Little-Known Emmaus Just Won Approval for First New Sickle Cell Drug in 20 Years 7/11/2017
Piedmont Pharmaceuticals Release: FDA Clears Pesticide-Free Resultz Lice & Egg Elimination Kit 7/11/2017
FDA Green Lights Medtronic (MDT)'s CoreValve Evolut TAVR In Intermediate Risk Patients 7/11/2017
Clinigen And Cumberland Pharmaceuticals (CPIX) Obtain FDA Approval For Totect In The U.S. 7/10/2017
BeyondSpring Granted Approval To Start China Trials Of Plinabulin 7/10/2017
Solasia Pharma K.K. Announces Approval Of Episil (Oral Liquid) In Japan 7/7/2017
Bristol-Myers Squibb (BMY)’s Orencia (Abatacept) Receives FDA Approval For Treatment Of Active Psoriatic Arthritis (PsA) in Adults 7/6/2017
K2M Wins FDA Clearance & CE Mark for NILE Proximal Fixation Spinal System 7/6/2017
Breckenridge Pharmaceutical, Inc. Announces Final Approval For Omeprazole Delayed-Release Capsules 7/6/2017
IMPAX Labs (IPXL) Announces FDA Approval And Launch Of Additional Strengths Of Generic Focalin XR (Dexmethylphenidate Hydrochloride) Extended-Release Capsules CII 7/6/2017
Novartis AG (NVS) Receives Approval In The EU For Cosentyx Label Update, Includes Long Term Superiority Data Versus Stelara In Psoriasis 7/6/2017
Isodiol International Receives Regulatory (ANVISA) Approval For Isoderm For The Treatment Of Epilepsy And Parkinson's 7/6/2017
BioCad’s Rituximab Biosimilar To Receive MA Soon In India 7/5/2017
Ipsen (IPN.PA): Somatuline Autogel 120 Mg Receives Japanese Approval For A New Indication For The Treatment Of Gastro-Entero-Pancreatic Neuroendocrine Tumors 7/5/2017
Chembio (CEMI.OB)’s DPP Zika System Including The DPP Micro Reader Approved By Brazil’s Health Regulatory Agency 7/5/2017
Eli Lilly (LLY) Release: Japan Ministry of Health, Labor And Welfare (MHLW) Grants Marketing Approval For Olumiant (Baricitinib) For The Treatment Of Rheumatoid Arthritis 7/5/2017
Pfizer (PFE) Release: BESPONSA Approved In The EU For Adult Patients With Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia 6/30/2017
Amgen (AMGN) Release: FDA Approves Vectibix (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer 6/30/2017
Arbor Pharma And Debiopharm Announce U.S. FDA Approval For Triptodur, Triptorelin 6-Month Formulation, In The Treatment Of Central Precocious Puberty (CPP) 6/30/2017
Quidel (QDEL)'s RSV Immunoassay Cleared by the FDA, CLIA Waived 6/29/2017
Novartis AG (NVS) Receives EU Approval For First-Line Use Of Zykadia In ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) 6/29/2017
FDA Green Lights LivaNova (LIVN)'s VNS Therapy for Drug-Resistant Epilepsy in Kids 6/29/2017
Medtronic (MDT)'s SureTune3 Earns CE Mark for DBS Therapy 6/28/2017
European Commission (EC) Approves Almirall’s Skilarence For Moderate-To-Severe Chronic Plaque Psoriasis 6/28/2017
The FDA Has Never Approved A Drug Like This In Its 111-Year History 6/27/2017
Regeneron (REGN) And Sanofi (SNY) Announce Approval Of Kevzara (Sarilumab) To Treat Adult Patients With Moderately To Severely Active Rheumatoid Arthritis In The European Union 6/27/2017
Swedish Orphan Biovitrum Release: EMA Approves The Potential To Dose Every 14 Days Or Longer In Updated Dosing Regimen For Alprolix 6/27/2017
Esperion (ESPR) Announces FDA Confirmation Of Regulatory Pathway To Approval For The Combination Of Bempedoic Acid And Ezetimibe 6/27/2017
QS Pharma Receives Approval From EMA For Commercial Manufacture 6/27/2017
Bay Area's Portola (PTLA) Rockets as the FDA Approves First and Only Anticoagulant for Hospitals 6/27/2017
Lannett (LCI) Receives Approval For Additional Dosage Strengths Of Hydrocodone Bitartrate And Acetaminophen Tablets USP 6/26/2017
CSL Behring Release: FDA Approves HAEGARDA (C1 Esterase Inhibitor Subcutaneous [Human]), First And Only Subcutaneous Preventive Treatment For Hereditary Angioedema 6/26/2017
Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Azacitidine For Injection (Vidaza) 6/26/2017
Novartis AG (NVS) Combination Targeted Therapy Tafinlar + Mekinist Receives FDA Approval For BRAF V600E Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC) 6/23/2017
FDA Approves Genentech (RHHBY)'s RITUXAN HYCELA, A Subcutaneous Rituximab Coformulated With Halozyme ENHANZE Technology 6/23/2017
BioDelivery (BDSI) Announces Health Canada Approval Of BELBUCA 6/23/2017
Roche (RHHBY) Scores FDA Nod For Fourth-Generation HIV Combination Antigen-Antibody Assay 6/23/2017
Lannett (LCI) Receives Approval For Hydrocodone Bitartrate And Acetaminophen Tablets USP, 5 Mg/300 Mg, 7.5 Mg/300 Mg And 10 Mg/300 Mg 6/22/2017
Merit Medical (MMSI)’s Embosphere Microspheres Receive FDA 513(F)(2) (De Novo) Classification For Prostatic Artery Embolization Indication 6/22/2017
Pfizer (PFE) Receives Expanded Health Canada Approval For IBRANCE In HR+, HER2- Metastatic Breast Cancer 6/21/2017
FDA Green Lights ClearFlow's FlowGlide Technology for Cardiac Surgery Patients 6/21/2017
LivaNova (LIVN) Release: VNS Therapy Receives FDA Approval For Expanded MRI Labeling 6/21/2017
Shire (SHPG): U.S. FDA Approves Mydayis (Mixed Salts Of A Single-Entity Amphetamine Product) - A New Once-Daily Option For ADHD Symptom Control In Patients 13 Years And Older 6/21/2017
Neos Therapeutics (NEOS) Announces FDA Approval Of Cotempla XR-ODT (Methylphenidate) Extended-Release Orally Disintegrating Tablets For The Treatment Of ADHD In Patients 6 To 17 Years Old 6/20/2017
ConforMIS Wins FDA 510(k) Clearance for iTotal Hip System 6/20/2017
Sonoma Pharma (OCLS) Announces Two Singapore Approvals For Microcyn (Hypochlorous Acid) For The Treatment Of Atopic Dermatitis And Hypertrophic / Keloid Scars 6/20/2017
Melinta Announces FDA Approval Of Baxdela (Delafloxacin) For Acute Bacterial Skin And Skin Structure Infections (ABSSSI) 6/20/2017
Ligand (LGND)’s Partner Melinta Announces U.S. FDA Approval Of Baxdela (Delafloxacin) For Acute Bacterial Skin And Skin Structure Infections (ABSSSI) 6/20/2017
Janssen Biotech (JNJ) Release: DARZALEX (daratumumab) Approved By The U.S. FDA In Combination With Pomalidomide And Dexamethasone For Patients With Multiple Myeloma Who Have Received At Least Two Prior Therapies 6/19/2017
Horizon Pharma (HZNP) Announces Health Canada Approval Of PROCYSBI (Cysteamine Delayed-Release Capsules) For The Treatment Of Nephropathic Cystinosis 6/19/2017
Novartis AG (NVS) Makes Another Dent Into The Biosimilar Market With Approval Of Rixathon 6/19/2017
A Peek At Adamis (ADMP) Ahead Of FDA Approval 6/16/2017
Mayne Pharma Announces FDA Approval And Immediate Launch Of Doxycycline Hyclate IR Tablets, First Generic To Acticlate 6/16/2017
Ipsen (IPN.PA) Announces FDA Approval Of Dysport (Abobotulinumtoxina) For The Treatment Of Lower Limb Spasticity In Adults 6/16/2017
Lannett (LCI) Announces Approval For Amantadine Hydrochloride Capsules USP, 100 Mg 6/16/2017
Adamis (ADMP) Snags FDA Approval For Its Epinephrine Pre-Filled Syringe 6/16/2017
Skyline Medical Announces CE Mark For The STREAMWAY System 6/15/2017
Milestone Scientific (MS) Snags 510(k) FDA Clearance for Epidural Anesthesia System 6/13/2017
GenMark Diagnostics (GNMK) Bags FDA Clearance for Its ePlex Instrument and Respiratory Pathogen Panel 6/12/2017
Etiometry Receives FDA 510(K) Clearance To Expand The Indications On Its IDO2 Index Powered By Risk Analytics 6/12/2017
FDA Clears W. L. Gore & Associates's GORE SYNECOR Preperitoneal Biomaterial Hernia Repair Device 6/7/2017
AngioDynamics (ANGO) Wins FDA Clearance for The Solero Microwave Tissue Ablation System 6/7/2017
Baxter International (BAX) Announces U.S. FDA Approval And Commercial Launch Of Ready-To-Use Clindamycin Injection In Saline 6/7/2017
How Much is Too Much to Pay for Newly Approved Drugs? 6/7/2017
Edwards Lifesciences (EW)' SAPIEN 3 Valve Wins FDA Nod for Aortic, Mitral Valve-In-Valve Procedures 6/6/2017
FDA Green Lights QIAGEN N.V. (QGEN)'s CMV Testing on Automated QIAsymphony Platform 6/6/2017
OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters 6/6/2017
Novartis AG (NVS) Drug Tasigna Receives EU Approval For Inclusion Of Treatment-Free Remission (TFR) Data In Product Label 6/6/2017
Clarify Medical Core Technology Receives FDA Clearance 6/6/2017
Alkermes (ALKS) Release: FDA Approves Two-Month ARISTADA For Treatment Of Schizophrenia 6/6/2017
Becton, Dickinson and Company (BDX) Nabs FDA Clearance for Molecular Test for Harmful Intestinal Bacteria Causing Infectious Diarrhea 6/5/2017
Bay Area's Claret Medical Wins FDA Nod to Market Sentinel Cerebral Protection System in the U.S. 6/5/2017
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab) For Previously Treated Locally Advanced Unresectable Or Metastatic Urothelial Carcinoma In Adults After Failure Of Prior Platinum-Containing Therapy 6/5/2017
OxOnc Announces That Co-Development Partner Has Received Approval In Japan And Taiwan For Crizotinib (Xalkori) As A First-Line Treatment For Patients With ROS1-Positive Non-Small Cell Lung Cancer 6/2/2017
Nexus Pharma Receives FDA Approval For Sodium Nitroprusside Injection 6/2/2017
FDA Approves New Novo Nordisk A/S (NVO) Treatment For Patients With Hemophilia 6/1/2017
BioMarin (BMRN) Release: European Commission (EC) Approves Brineura (Cerliponase Alfa), The First Treatment For CLN2 Disease, A Form Of Batten Disease And Ultra-Rare Brain Disorder In Children 6/1/2017
Ionis Pharma (IONS) Release: SPINRAZA (Nusinersen) Approved In The European Union 6/1/2017
FDA Green Lights Intuitive Surgical (ISRG)'s da Vinci X Surgical System 5/31/2017
Augmenix Release: SpaceOAR System Receives Shonin Approval In Japan 5/31/2017
NicOx SA (COX.PA) Receives FDA Approval Of ZERVIATE1 (Cetirizine Ophthalmic Solution) 0.24% 5/31/2017
Merck & Co. (MRK) Receives FDA Approval Of ISENTRESS HD (Raltegravir), A New Once-Daily Option, In Combination With Other Antiretroviral Agents, For The Treatment Of HIV-1 Infection In Appropriate Patients 5/30/2017
Novartis AG (NVS) Receives FDA Approval For Expanded Use Of Zykadia In First-Line ALK-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) 5/30/2017
Masimo (MASI) Nabs FDA Clearance of O3 Regional Oximetry for Pediatric Patients 5/30/2017
FDA Grants Market Clearance to RA Medical's New PAD System 5/30/2017
European Commission (EC) Approves Pfizer (PFE)’s TRUMENBA To Help Prevent Meningococcal Group B Disease In Adolescents And Adults 5/30/2017
Bayer (BAY) Receives FDA Approval Of myBETAapp And BETACONNECT Navigator 5/30/2017
Sobi Canada (B6E.F) Release: Kineret Approved In Canada For The Treatment Of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) 5/30/2017
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
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
Mitsubishi Tanabe Wins FDA Approval for Radicava, the First New ALS Drug in 22 Years 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
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
Wowsers! FDA Approves BioMarin (BMRN)'s Brineura, the First Drug for Batten Disease 5/2/2017
Takeda (TKPYY)'s $5 Billion Bet on Ariad (ARIA) Pays Off With Accelerated Approval of Lung Cancer Med 5/1/2017
FDA Clears Faxitron's LOCalizer Radiofrequency ID System for Breast Lesion Localization 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