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Clinical - Approvals
ClaroNav's NaviENT Nabs FDA 510(K) Clearance 9/22/2017
Eisai Company (ESALY.PK): Additional Dosage And Administration Of Proton Pump Inhibitor Pariet (R) 5 Mg Tablets, 10 Mg Tablets Approved In Japan For Maintenance Therapy Of Proton Pump Inhibitor Resistant Reflux Esophagitis 9/22/2017
Bristol-Myers Squibb (BMY) Release: Japan Ministry Of Health, Labor And Welfare Approves Opdivo (Nivolumab) For The Treatment Of Patients With Unresectable Advanced Or Recurrent Gastric Cancer Which Has Progressed After Chemotherapy 9/22/2017
Covalon Technologies Wins FDA Clearance for MediClear PreOp 9/21/2017
BrainLAB AG Snags FDA Win for Two New Indication-Specific Radiosurgery Software Applications 9/21/2017
Perrigo (PRGO) Announces FDA Final Approval For Its AB Rated Generic Version Of Exalgo 32mg Extended Release Tablets 9/21/2017
Biocryst (BCRX)’s RAPIVAB (peramivir injection) Receives FDA Approval For A Pediatric Indication 9/21/2017
Amphastar (AMPH) Receives FDA Approval For Sodium Bicarbonate Injection 9/21/2017
Stryker (SYK) Wins FDA Nod for 3D-Printed Tritanium C Anterior Cervical Cage 9/20/2017
FDA Green Lights Arkis Biosciences' CerebroFlo EVD Catheter With Endexo Technology 9/20/2017
Lexicon Pharma (LXRX) Release: European Commission (EC) Approves XERMELO (Telotristat Ethyl) For The Treatment Of Carcinoid Syndrome Diarrhea In Combination With Somatostatin Analog Therapy 9/20/2017
Novartis AG (NVS) Drug Rydapt (Midostaurin) Receives EU Approval For Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) And Three Types Of Advanced Systemic Mastocytosis (SM) 9/20/2017
GlaxoSmithKline (GSK) Investors Rejoice After Winning A Much-Needed OK For Triple COPD Drug Inhaler 9/19/2017
Theravance Biopharma (TBPH) Highlights Approval Of Trelegy Ellipta (Closed Triple) As The First Once-Daily Single Inhaler Triple Therapy For The Treatment Of Appropriate Patients With COPD In The U.S. 9/19/2017
FDA Approves Symbiomix’ Solosec (Secnidazole) Oral Granules For The Treatment Of Bacterial Vaginosis In Adult Women 9/19/2017
Cycle Pharma Receives FDA Approval And Launches Ketorolac Tromethamine Injection 30mg/ml In The U.S. 9/19/2017
OptiNose Announces FDA Approval Of XHANCE (Fluticasone Propionate) Nasal Spray For The Treatment Of Nasal Polyps 9/19/2017
Teligent Announces FDA Approval Of Triamcinolone Acetonide Cream USP, 0.1% 9/19/2017
Ipsen (IPN.PA) Receives Approval From European Commission (EC) For Xermelo (Telotristat Ethyl) For The Treatment Of Carcinoid Syndrome Diarrhea In Patients Inadequately Controlled By Somatostatin Analogue Therapy 9/19/2017
Amgen (AMGN), Allergan (AGN) Make History With First Cancer Biosimilar OK—Will Take on Genentech (RHHBY)'s $6 Billion Best-Seller 9/18/2017
FDA Green Lights Masimo (MASI)'s Rad-97 Pulse CO-Oximeter 9/18/2017
U.S. FDA Approves New Indication For Ipsen (IPN.PA)'s Somatuline Depot (Lanreotide) Injection For The Treatment Of Carcinoid Syndrome 9/18/2017
SurModics (SRDX) Nabs Global Approvals of .014" Low-Profile PTA Balloon Dilation Catheter 9/18/2017
FDA Approves Symbiomix’ Solosec (Secnidazole) Oral Granules For The Treatment Of Bacterial Vaginosis In Adult Women 9/18/2017
Medtronic (MDT) Wins FDA Nod and Launch of Next Generation Chronic Pain Spinal Cord Stimulator 9/18/2017
Neos Therapeutics (NEOS) Receives U.S. FDA Approval Of Adzenys ER (Amphetamine) Extended-Release Oral Suspension For The Treatment Of ADHD In Patients 6 Years And Older 9/18/2017
Pear Therapeutics Wins FDA Nod for the First-Ever Medical App for Treating Drug Addiction 9/15/2017
CSL Behring Announces FDA Approval Of Privigen [Immune Globulin Intravenous (Human), 10% Liquid] For The Treatment Of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) In Adults 9/15/2017
New Indication For BRIVIACT (Brivaracetam): UCB's Newest Antiepileptic Drug Approved By FDA As Monotherapy Treatment Of Partial-Onset Seizures In Adults 9/15/2017
Bayer (BAY) Receives FDA Approval For Aliqopa (copanlisib) 60 Mg Vial For Injection In Adults With Relapsed Follicular Lymphoma After Two Prior Systemic Therapies 9/15/2017
Amicus (FOLD) Announces Approval For Galafold (Migalastat) For Treatment Of Fabry Disease In Canada 9/15/2017
Seqirus Receives FDA Approval Of Afluria Quadrivalent (Influenza Vaccine) For People Five Years Of Age And Older In The U.S. 9/14/2017
Guerbet (GBT) Announces CE Mark For Vectorio, An Innovative Medical Device For cTACE Procedures 9/14/2017
Summit Biosciences Receives EU Approval For Commercial Manufacturing Of Prescription Nasal Sprays 9/14/2017
Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A 9/12/2017
Medtronic (MDT) Announces New StealthStation Technology For Ear, Nose, And Throat Procedures 9/12/2017
VANC Pharmaceuticals Receives Health Canada Class-III Approval For Ferrous Fumarate Products 9/11/2017
Medtronic (MDT) Announces Japanese Regulatory Approval For The IN.PACT Admiral Drug-Coated Balloon 9/8/2017
VANC Pharmaceuticals Announces Provincial Formulary Approvals For Atlantic Canada 9/7/2017
FDA Approves Guerbet (GBT)'s Dotarem (Gadoterate Meglumine) For Pediatric Patients Younger Than Two Years 9/6/2017
Actelion (ALIOF.PK) Receives FDA Approval Of TRACLEER (bosentan) For Use In Pediatric Patients With Pulmonary Arterial Hypertension 9/6/2017
Innovus Pharma Receives Approval From Health Canada For Its Urivarx Product For The Indication To Reduce Symptoms Of Overactive Bladder Such As Daytime Urinary Frequency, Urgency And Nocturia 9/6/2017
Bioventus Receives U.S. FDA Approval For DUROLANE 9/5/2017
European Commission (EC) Approves Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) For The Treatment Of Certain Patients With Locally Advanced Or Metastatic Urothelial Carcinoma, A Type Of Bladder Cancer 9/5/2017
iCAD (ICAD) Announces Approval Of Xoft Axxent Balloon Applicators By China Food & Drug Administration For Treatment Of Early-Stage Breast Cancer 9/5/2017
Sobi Receives Approval From The FDA For Once-Daily Dosing Frequency Of Orfadin (Nitisinone) For The Treatment Of HT-1 9/5/2017
The Leukemia & Lymphoma Society Release: FDA Approval Of Targeted Therapy For Acute Myeloid Leukemia Is A Significant Advance For Deadly Blood Cancer 9/5/2017
Lannett (LCI) Receives Approval For Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg And 40 mg 9/5/2017
Novartis AG (NVS) Waltzes to the Finish Line With First Ever FDA Approval for CAR-T 9/1/2017
ANI Pharma Announces Approval And Launch Of Oxycodone Hydrochloride Oral Solution, 100 Mg/5ml 9/1/2017
Adherium Snags FDA Clearance for Next Generation Smartinhaler for AstraZeneca PLC (AZN)'s Symbicort Aerosol Inhaler 9/1/2017
Pfizer (PFE) Receives FDA Approval For Mylotarg (Gemtuzumab Ozogamicin) 9/1/2017
Amgen (AMGN) Release: European Commission (EC) Approves Expanded Use Of Mimpara (Cinacalcet) For The Treatment Of Secondary Hyperparathyroidism In Children With End-Stage Renal Disease On Dialysis 9/1/2017
First FDA Approved Cell Therapy For Leukemia Utilizes Thermo Fisher Scientific (TMO)'s CTS Dynabeads Technology 8/31/2017
Dexterity Surgical, Inc. Receives Expanded Indication In Solid Organ Surgery For Microcutter 5/80 8/31/2017
Apollo Endosurgery Announces CE Mark Approval For The ORBERA365 Managed Weight Loss System, Expanding The Indwell Period From 6 Months To 12 Months With The Gastric Balloon Category Leader 8/31/2017
Teva (TEVA) Announces FDA Approval Of AUSTEDO (Deutetrabenazine) Tablets For The Treatment Of Tardive Dyskinesia In Adults 8/31/2017
Smiths Medical Snags FDA 510(k) Clearance on Wireless Ambulatory Infusion Pump 8/30/2017
FDA Grants Accelerated Approval For The Medicines Company (MDCO)'s UTI Drug 8/30/2017
FDA Approves Personalized Cellular Therapy For Advanced Leukemia Developed By University of Pennsylvania And Children's Hospital of Philadelphia 8/30/2017
iCAD (ICAD) Announces Approval Of Xoft Axxent Balloon Applicators By China Food & Drug Administration For Treatment Of Early-Stage Breast Cancer 8/30/2017
FDA Approves Genentech (RHHBY)’s Actemra (Tocilizumab) For The Treatment Of CAR T Cell-Induced Cytokine Release Syndrome 8/30/2017
FDA OKs Chemo Research, S. L. 's Benznidazole, The First U.S. Treatment For Chagas Disease 8/30/2017
Abbott (ABT) Wins Approval to Sell New Pump to Treat Heart Failure 8/29/2017
Boehringer Ingelheim Pharmaceuticals, Inc. Receives FDA Approval For Cyltezo (Adalimumab-Adbm), A Biosimilar To Humira, For The Treatment Of Multiple Chronic Inflammatory Diseases 8/29/2017
AstraZeneca PLC (AZN) Release: Faslodex (Fulvestrant) Receives U.S. FDA Approval As Monotherapy For Expanded Use In HR+, HER2- Advanced Breast Cancer 8/28/2017
NxStage (NXTM) Wins FDA Clearance for Solo Home Hemodialysis Using NxStage System One 8/28/2017
AVEO Oncology (AVEO) Announces FOTIVDA (Tivozanib) Approved In The European Union For The Treatment Of Advanced Renal Cell Carcinoma 8/28/2017
Novo Nordisk A/S (NVO) Release: Health Canada Approves Tresiba, A New Basal Insulin For Type 1 And 2 Diabetes 8/28/2017
C. R. Bard, Inc. (BCR) Snags FDA Premarket Approval of The Lutonix 035 Drug Coated Balloon As The First And Only DCB 8/28/2017
Novo Nordisk A/S (NVO) Release: Victoza (Liraglutide) Is Approved In The U.S. As The Only Type 2 Diabetes Treatment Indicated To Reduce The Risk Of Three Major Adverse Cardiovascular Events 8/28/2017
Tandem Medical Snags FDA Nod of t:slim X2 Insulin Pump With Dexcom G5 Mobile CGM Integration 8/28/2017
Adamas (ADMS) Wins FDA OK for the First and Only Drug for Parkinson's Dyskinesia Drug 8/25/2017
Kedrion And Kamada (KMDA) Receive FDA Approval Of KEDRAB For Post-Exposure Prophylaxis Against Rabies Infection 8/25/2017
IMRALDI, Biogen (BIIB)’s Adalimumab Biosimilar Referencing Humira, Is Approved In The European Union 8/25/2017
Samsung Bioepis First To Obtain European Commission (EC) Approval For A Third Anti-TNF-? Biosimilar With Imraldi (Adalimumab) 8/25/2017
VANC Pharmaceuticals Receives Updated Health Canada Approval For Hema-Fer With New Indication For Use In Pregnancy 8/25/2017
The European Commission (EC) Finally Approves Merck KGaA (MKGAF.PK)'s Once-Failed MS Drug Cladribine 8/25/2017
Novartis AG (NVS) Kisqali (Ribociclib) Receives EU Approval As First-Line Treatment For HR+/HER2- Locally Advanced Or Metastatic Breast Cancer In Combination With Any Aromatase Inhibitor 8/24/2017
Astex Pharma (ASTX) Celebrates As Cancer Drug Receives Marketing Approval In Europe 8/24/2017
Creo Medical Grabs FDA Clearance For New Speedboat RS2 Device And CROMA System 8/24/2017
Malin (MLC.IR) Snags FDA Approval for New Hourglass Peripheral Embolisation Plug 8/22/2017
Teligent Announces FDA Approval of Clobetasol Propionate Cream USP, 0.05%, Emollient 8/22/2017
BESPONSA (Inotuzumab Ozogamicin) Approved For Treatment Of Adult Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, Available For Order At Biologics 8/22/2017
Octapharma USA Announces FDA Approval Of NUWIQ New Product Strengths, Expanding Hemophilia A Patient Treatment Options 8/22/2017
Ironwood (IRWD) Announces FDA Approval Of DUZALLO (Lesinurad And Allopurinol) For The Treatment Of Hyperuricemia In Patients With Uncontrolled Gout 8/21/2017
Perrigo (PRGO) Announces Final FDA Approval And Settlement For The Store Brand OTC Equivalent Of Nexium 24HR Capsules 8/21/2017
Alexion (ALXN) Release: European Commission (EC) Grants New Indication For Soliris (Eculizumab) For The Treatment Of Patients With Refractory Generalized Myasthenia Gravis (gMG) 8/21/2017
Medtronic (MDT) Receives CE Mark For Attain Stability Quad MRI SureScan Active-Fixation Heart Lead 8/21/2017
Heads Up Tesaro (TSRO): AstraZeneca PLC (AZN), Merck & Co. (MRK)'s Ovarian Cancer Drug Just Got Expanded Use From the FDA 8/18/2017
FDA Green Lights Pfizer (PFE) Drug for Rare, Fast-Killing Type of Leukemia 8/18/2017
This is What Happens When the FDA Approves Cancer Drugs Too Quickly 8/17/2017
Globus Medical (GMED) Wins FDA 510(k) Clearance for Excelsius GPS 8/17/2017
AbbVie (ABBV)'s MAVIRET Approved By Health Canada For The Treatment Of Chronic Hepatitis C In All Major Genotypes 8/17/2017
Stryker (SYK)’s Spine Division Wins FDA Clearance for Serrato Pedicle Screw 8/16/2017
Perrigo (PRGO) Announces FDA Final Approval For Its AB Rated Generic Version Of Mycolog II Cream 8/16/2017
Amicus (FOLD) Announces Approval For Galafold (Migalastat) For Treatment Of Fabry Disease In Australia 8/16/2017
Shire Canada Release: ONIVYDE (Irinotecan Liposome For Injection) Has Received Approval In Canada For The Treatment Of Metastatic Adenocarcinoma Of The Pancreas In The Post-Gemcitabine Setting(1) 8/11/2017
Renovis Surgical Wins FDA OK for 3D-Printed Posterior Lumbar Interbody Fusion Systems 8/11/2017
Oasmia Receives Market Approval For Its Anti-Cancer Drug Doxophos In Russia 8/10/2017
In2Bones USA Scores FDA OK on Two Key Implant Systems 8/9/2017
Xtant Medical Gets FDA Greenlight for Calix-C Cervical Interbody Line Extension and Expanded Indications 8/9/2017
Optovue, Inc. Wins FDA’s First Clearance for Corneal Epithelial Thickness Mapping 8/9/2017
Stimwave Receives FDA 510(k) Clearance for the First Full-Body MRI Scan Ready Wireless Peripheral Nerve Stimulator (PNS) System 8/9/2017
FDA Approves AUM Cardio’s Revolutionary Diagnostic Heart Device 8/8/2017
Optovue, Inc. First In U.S. To Receive FDA Clearance For Corneal Epithelial Thickness Mapping 8/8/2017
Mauna Kea Technologies Gets U.S. FDA 510(K) Clearance for Use of Cellvizio During Robotic-Assisted Surgery 8/8/2017
Wockhardt (WOCKHARDT.BO)'s Antibiotic Injection Gets U.S. FDA Approval 8/7/2017
GE Healthcare's SIGNA Premier Cleared by the U.S. FDA 8/7/2017
Teva (TEVA) Announces FDA Approval Of QVAR RediHaler (Beclomethasone Dipropionate HFA) Inhalation Aerosol 8/7/2017
CMP Pharma Announces FDA Approval Of CaroSpir (Spironolactone Oral Suspension, 25 Mg/5 mL) 8/7/2017
AbbVie (ABBV) Wins FDA Approval for the First-Ever Drug to Treat All Forms of Hep C 8/7/2017
Nexus Pharma Receives FDA Approval For Isoproterenol Hydrochloride Injection USP 8/4/2017
Standard Bariatrics Receives FDA Clearance for STANDARD CLAMP 8/4/2017
Enanta Pharmaceuticals, Inc. Announces U.S. FDA Approval Of AbbVie (ABBV)’s MAVYRET (Glecaprevir/Pibrentasvir) For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6) In As Little As 8 Weeks 8/4/2017
Avacen Medical Gets CE Mark for Increasing Microcirculation and Treating Widespread Fibromyalgia Pain 8/4/2017
Pharma Giant AstraZeneca PLC (AZN) Scores Another FDA Breakthrough 8/3/2017
Jazz Pharma (JAZZ) Vyxeos Scores FDA Approval in Two AML Types 8/3/2017
Johnson & Johnson (JNJ)'s Imbruvica Scores Expanded FDA Approval for Chronic Graft vs Host Disease 8/3/2017
Oncotherm Release: Saudi Arabia Approves Oncothermia, The Latest Technology In Cancer Treatment 8/3/2017
Agios (AGIO), Celgene (CELG) Win Early FDA Approval for New Cancer Drug 8/3/2017
Medtronic (MDT) Bags Approval for Avalus Valve in U.S. and Europe 8/2/2017
Blood Markers Of Chronic Fatigue Syndrome Could Pave The Way To A Diagnostic Test, Stanford Reveals 8/2/2017
FDA OKs Xavant Technology's Stimpod NMS460 Non-Invasive Neuromodulation Device 8/2/2017
Bristol-Myers Squibb (BMY) Receives FDA Approval For Opdivo (Nivolumab) In MSI-H Or Dmmr Metastatic Colorectal Cancer That Has Progressed Following Treatment With A Fluoropyrimidine, Oxaliplatin, And Irinotecan 8/1/2017
Vertex (VRTX) Release: FDA Approves KALYDECO (Ivacaftor) For More Than 600 People Ages 2 And Older With Cystic Fibrosis Who Have Certain Residual Function Mutations 8/1/2017
Graminex L.L.C. Receives NNHPD Health Canada Approval For Pollenaid And Prostanex 8/1/2017
LivaNova (LIVN) Release: VNS Therapy Receives CE Mark For Expanded MRI Labeling 8/1/2017
Cycle Pharma Receives FDA Approval Of Nityr (Nitisinone) Tablets For Treatment Of HT-1 8/1/2017
Otsuka Pharma Release: ABILIFY MAINTENA (Aripiprazole) For Extended-Release Injectable Suspension Approved By U.S. FDA For Maintenance Monotherapy Treatment Of Bipolar I Disorder 7/31/2017
Myomo Obtains CE Mark Approval For Myopro 7/31/2017
Immunalysis Receives First-Ever FDA OK For SEFRIA Fentanyl Urine Drug Screening Test 7/31/2017
EnteroMedics (ETRM) Receives Approval for Gastric Vest System Clinical Study in Spain 7/31/2017
Bracco Diagnostics Receives U.S. FDA Approval For VARIBAR NECTAR (Barium Sulfate) Oral Suspension 7/28/2017
Quantel Medical Snags FDA Approval for Easyret Photocoagulator Laser 7/28/2017
TrovaGene (TROV) Announces FDA Approval Of IND For Phase Ib/II Trial Of PCM-075 In Patients With Acute Myeloid Leukemia 7/27/2017
FDA Approves Eisai Inc. (ESALF.PK)'s FYCOMPA (Perampanel) For Use As Monotherapy For The Treatment Of Partial-Onset Seizures 7/27/2017
Aspect Imaging Nabbed $150 Million and FDA Clearance of the First Dedicated Neonatal MRI System 7/27/2017
Spectranetics (SPNC) Secures FDA Approval of Stellarex Drug-Coated Balloon 7/27/2017
Novo Nordisk A/S (NVO): Victoza Has Been Approved In The EU As The Only GLP-1 With A Label To Include Prevention Of Cardiovascular Events 7/27/2017
Acella Pharmaceuticals, LLC, Announces Approval Of Generic To Vituz Oral Solution 7/27/2017
Sensus Healthcare (SRTSU) Receives Regulatory Approval To Sell The SRT-100 In China For The Treatment And Prevention Of Keloids 7/26/2017
Bristol-Myers Squibb (BMY)’s ORENCIA (Abatacept) Receives Second European Commission (EC) Approval In Less Than A Year – New Approval For Treatment Of Active Psoriatic Arthritis (PsA)1 7/26/2017
Seattle Genetics (SGEN) Release: Health Canada Approves ADCETRIS (Brentuximab Vedotin) For The Post-ASCT Consolidation Treatment Of Patients With Hodgkin Lymphoma At Increased Risk Of Relapse Or Progression 7/25/2017
ChiRhoClin Release: ChiRhoStim (Human Secretin For Injection) ChiRhoClin Approved Labeling Update And 5-Year Shelf Life Approval 7/25/2017
Viriom Obtains First Market Approval Of Elsulfavirine (Elpida) For Treatment Of HIV-1 Infection In Russia 7/25/2017
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
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
FDA Green Lights Gilead (GILD)'s Vosevi, With a Black Box Warning Attached 7/20/2017
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
Puma Biotech (PBYI) Surges After the FDA Officially Approves Breast Cancer 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
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
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
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



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