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Clinical - Approvals
Braeburn Pharma Announces FDA Approves Probuphine (Buprenorphine) Implant: The First Implant For Treatment Of Opioid Dependence 5/27/2016
U.S. FDA Approves CSL Behring's AFSTYLA-- The First And Only Recombinant Factor VIII Single Chain Therapy For Hemophilia A 5/27/2016
Titan Pharma (TTNP) Receives FDA Approval for the First Ever Implantable Device for Opioid Dependency 5/27/2016
Sanofi (SNY) Snags FDA Panel's Support for New Once-Daily Diabetes Combo iGlarLixi 5/26/2016
FDA Panel Backs St. Jude Medical (STJ)’s Amplatzer Stroke Device 5/26/2016
Ortho Kinematics Secures Health Canada Approval 5/26/2016
European Union Expands CE Mark Approval To Advanced Cooling Therapy’s Esophageal Cooling Device For 120 Hours Duration Of Use 5/25/2016
Bristol-Myers Squibb Canada (BMY) Release: Health Canada Approves DAKLINZA (Daclatasvir) For Difficult-To-Treat Hepatitis C Patient Populations 5/24/2016
Perimeter Medical Imaging Receives FDA Clearance for OTIS Optical Tissue Imaging System 5/24/2016
Seqirus Receives FDA Approval For FLUCELVAX QUADRIVALENT (Influenza Vaccine) For People Four Years Of Age And Older 5/24/2016
Janssen-Cilag International NV (JNJ)’s Single-Agent DARZALEX (daratumumab) Approved By European Commission For Treatment OIf Multiple Myeloma (MM) 5/23/2016
Cerus (CERS) Release: Health Canada Approves INTERCEPT Blood System For Plasma 5/23/2016
Teijin Pharma’s FEBURIC (Febuxostat) Approved As Indication For Cancer Chemotherapy-Induced Hyperuricemia 5/23/2016
Genentech (RHHBY) Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years 5/20/2016
Aratana Therapeutics (PETX) Granted FDA Approval Of ENTYCE (Capromorelin Oral Solution) 5/18/2016
Bristol-Myers Squibb (BMY) Release: Opdivo (nivolumab) Granted First Approval Of A PD-1 Inhibitor In Hematology For The Treatment Of Classical Hodgkin Lymphoma Patients Who Have Relapsed Or Progressed After Auto-HSCT And Post-Transplantation Brentuximab Vedotin By The FDA 5/18/2016
Mission Pharmacal Company Receives FDA Approval For Liquid Potassium Iodide Oral Solution For Nuclear Emergency Management 5/17/2016
FDA Approves Eisai Inc. (ESALF.PK)'s LENVIMA (Lenvatinib) For The Treatment Of Patients With Advanced Renal Cell Carcinoma In Combination With Everolimus Following Prior Anti-Angiogenic Therapy 5/16/2016
Teligent Announces FDA Approval Of Triamcinolone Acetonide Ointment USP, 0.1% 5/16/2016
Orthofix International NV (OFIX) Wins FDA Approval of FORZA PTC Interbody Spacer System 5/16/2016
Thermo Fisher Scientific (TMO) Receives FDA Clearance For EliA Anti-Thyroglobulin And Anti-Thyroid Peroxidase Tests For Autoimmune Thyroid Disease 5/16/2016
Swedish Orphan Biovitrum: Alprolix (rFIXFc) Approved In The EU For The Treatment Of Hemophilia B 5/13/2016
FDA Clears Next-Gen Version of EndoGastric Solutions’ EsophyX Device 5/12/2016
Bristol-Myers Squibb (BMY) And AbbVie (ABBV) Announce European Commission Approval Of Empliciti (Elotuzumab) For The Treatment Of Multiple Myeloma In Adult Patients Who Have Received At Least One Prior Therapy 5/12/2016
Senseonics Nabs CE Mark Approval for the Eversense CGM System 5/11/2016
Martindale Pharma Release: Prenoxad Injection Approved In Five European Countries Opening Way For Pan-European Availability Of A Take-Home Naloxone Product 5/11/2016
Integra LifeSciences (IART) Wins FDA Nod for Integra Omnigraft Dermal Regeneration Matrix 5/11/2016
European Commission (EC) Approves the First and Only Immuno-Oncology Combination, Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab) + Yervoy (Ipilimumab) Regimen, for Treatment of Advanced Melanoma 5/11/2016
European Commission (EC) Approves IDELVION --CSL Behring's Novel Hemophilia B Treatment With Up To 14-Day Dosing Intervals 5/11/2016
NinePoint Medical Snags FDA OK for Real-Time Targeting on Nvisionvle Device 5/10/2016
Pfizer Canada Release: Health Canada Approves New First-Line Treatment For Women Living With Metastatic Breast Cancer 5/10/2016
Theravance (THRX) Announces FDA Approval Of Expanded Label For VIBATIV (telavancin) 5/10/2016
Irvine Scientific Snags FDA Nod on Vitrification Media for Use With Oocytes 5/9/2016
TOLMAR Inc. Announces That FDA Approval Has Been Received For ELIGARD (Leuprolide Acetate For Injectable Suspension) Storage At Room Temperature For Up To 8 Weeks 5/6/2016
Signostics Wins FDA Nod for Uscan – The World’s First Smart Mobile-Connected Visualization Device Specialized for Urologic Care 5/6/2016
SentreHEART Receives 510k Approval for the LARIAT XT Suture Delivery Device 5/5/2016
FDA Clears Boston Scientific (BSX)'s Navigation-Enabled Ablation Catheters 5/4/2016
Acutus Medical Receives CE Mark For The Acqmap 3D High Resolution Imaging And Mapping System 5/4/2016
Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval For Lacosamide Tablets (Vimpat) 5/4/2016
AstraZeneca Canada (AZN) Release: Health Canada Approves LYNPARZA For The Treatment Of Ovarian Cancer In Patients With BRCA-Mutations 5/3/2016
Ferring Pharma Announces Approval For NOCDURNA, A New Therapeutic Option For The Treatment Of Adults Waking Multiple Times To Urinate At Night 5/3/2016
TGA Australia Approval Opens Up Australian Markets For Amanta Healthcare 5/3/2016
Allergan (AGN) Receives FDA Approval And Launches First Generic Version Of CRESTOR (Rosuvastatin) 5/2/2016
Eisai Inc. (ESALF.PK) Announces FDA Approval Of FYCOMPA (Perampanel) Oral Suspension For Adjunctive Therapy In The Treatment Of Partial-Onset Seizures And Primary Generalized Tonic-Clonic Seizures 5/2/2016
Orexigen (OREX) Announces South Korean Approval Of Contrave (Naltrexone HCI And Bupropion HCI Extended-Release) Monotherapy For Weight Management In Overweight Or Obese Adult Patients 5/2/2016
Perrigo (PRGO) Announces FDA Approval And Launch Of The Generic Version Of BenzaClin Pump Topical Gel 5/2/2016
FDA Green Lights Medtronic (MDT)'s Afib-Detecting Visia ICD 5/2/2016
Flamel Technologies (FLML) Receives FDA Approval Of Akovaz 5/2/2016
Synaptive Medical Receives FDA Clearance for Health Informatics Platform 5/2/2016
FDA Clears Acadia (ACAD)'s NUPLAZID, the First Drug for Psychosis Linked to Parkinson's 5/2/2016
FDA Approves Bayer (BAY)'s Gadavist (Gadobutrol) Injection As First Contrast Agent For Use With Magnetic Resonance Angiography Of Supra-Aortic Arteries 4/29/2016
Teva (TEVA) Announces FDA Approval Of Proair Respiclick (Albuterol Sulfate) Inhalation Powder For Pediatric Asthma Patients Ages 4 To 11 4/29/2016
Taiho Pharma Release: Patients With Advanced Metastatic Colorectal Cancer In Europe Now Have New Treatment Option As LONSURF (Trifluridine/Tipiracil) Receives EU Approval 4/28/2016
Sobi Release: FDA Approves ORFADIN (Nitisinone) Oral Suspension 4/27/2016
Boston Scientific (BSX) Snags FDA Nod for ImageReady MR-Conditional Pacing System 4/26/2016
AtriCure (ATRC) Wins FDA Clearance for New AtriClip Device 4/26/2016
Intuity Med Wins FDA Approval to Market POGO Automatic Blood Glucose Monitoring System 4/26/2016
Swedish Orphan Biovitrum Release: Orfadin Oral Suspension Approved In The U.S. 4/26/2016
Aralez Receives Health Canada Approval For Blexten 4/25/2016
Enanta Pharmaceuticals, Inc. Announces FDA Has Approved AbbVie (ABBV)’s Supplemental New Drug Application For Use Of VIEKIRA PAK Without Ribavirin In Genotype 1b Chronic Hepatitis C Patients With Compensated Cirrhosis 4/25/2016
Exactech (EXAC) Nabs FDA 510(k) Clearance for Vantage Total Ankle 4/25/2016
W. L. Gore & Associates Excluder Iliac Branch Endoprosthesis Gains Health Canada Approval 4/21/2016
FUJIFILM VisualSonics Announces 510(K) Clearance For The World's First Ultra High Frequency Ultrasound For Humans 4/21/2016
Oculus Innovative Sciences (OCLS) Grabs FDA Approval for Lasercyn 4/20/2016
Ortho Kinematics Nabs CE Mark Approval for Spinal Motion Analyzer 4/20/2016
Avedro Wins FDA Approval for Photrexa Viscous, Photrexa and the KXL System for Corneal Cross-Linking 4/19/2016
Ortho Kinematics Secures CE Mark Approval To Support International Expansion 4/19/2016
Boehringer Ingelheim Release: FDA Approves Gilotrif (Afatinib) As New Oral Treatment Option For Patients With Squamous Cell Carcinoma Of The Lung 4/18/2016
Fractyl Snags CE Mark Approval for Revita DMR 4/15/2016
Eisai Company (ESALY.PK) Release: Aricept Approved In The Philippines For New Indication As Treatment For Dementia With Lewy Bodies 4/14/2016
Praxair Canada Receives Approval For Sale Of Noxivent Nitric Oxide 4/14/2016
AtriCure (ATRC) Snags 510(K) Clearance for the Cryoform Cryoablation Probe 4/12/2016
ndd Medical’s Easyone Spirometer Is The First PFT Device Approved For New Coal Miner Surveillance Program 4/12/2016
AbbVie (ABBV) Receives FDA Accelerated Approval Of Venclextatm(Venetoclax) Tablets, The First BCL-2 Inhibitor In Relapsed/Refractory Chronic Lymphocytic Leukemia Patients With 17p Deletion 4/12/2016
Genentech (RHHBY) Announces FDA Grants Venclexta (Venetoclax) Accelerated Approval For People With A Hard-To-Treat Type Of Chronic Lymphocytic Leukemia 4/12/2016
Synthon Pharmaceuticals Obtains Approval For Glatiramer Acetate 20 mg/mL In Europe 4/12/2016
EOS Imaging Receives FDA Approval For Spineeos, Its Online 3D Planning Solution For Spine Surgery 4/12/2016
FDA Green Lights AbbVie (ABBV), Genentech (RHHBY)'s New Chronic Lymphocytic Leukemia Drug Venclexta 4/12/2016
Profound Medical Receives CE Mark Approval For TULSA-PRO 4/11/2016
FDA Green Lights Abiomed (ABMD)'s Device to Treat Cardiac Shocks 4/8/2016
FDA OKs Advanced Surgical Concepts' Tissue Container for Laparoscopic Device 4/8/2016
Medtronic (MDT)'s Tiny Wireless Pacemaker Wins FDA Approval 4/7/2016
Cipher Pharma (DND.TO) Announces Approvals Of Astion Acquired Barrier Creams By Health Canada And The Medicines Evaluation Board 4/7/2016
Ligand (LGND) Release: Revolade Approved In EU As First In Class Therapy For Children Aged 1 Year And Above With Chronic ITP 4/7/2016 Approves Celltrion (068270.KQ)’s INFLECTRA, the First Cheaper Version of Johnson & Johnson (JNJ) Blockbuster Remicade 4/7/2016
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab) For Previously Treated Advanced Renal Cell Carcinoma 4/6/2016
European Commission (EC) Approves Expanded Use Of Bristol-Myers Squibb (BMY)'s Opdivo (Nivolumab) To Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer 4/6/2016
K2M’s MESA Mini And DENALI® Mini Spinal Systems Receive Additional FDA Clearance For Posterior Cervical Spine Fixation 4/6/2016
Pfizer (PFE) Receives European Approval For New Multi-Dose Vial Presentation Of Prevenar 13 4/6/2016
FDA Approves Gilead (GILD)'s Next-Generation HIV Drug Descovy 4/5/2016
ANI Pharma Announces FDA Approval Of Oxycodone Capsules, 5mg 4/5/2016
Ekso Bionics (EKSO) GT Robotic Exoskeleton Cleared by the FDA for Use With Stroke and Spinal Cord Injury Patients 4/4/2016
Health Canada Approves BioPharmX Study Of Violet Iodine 4/4/2016
Baxalta (BXLT) Expands Global Reach Of ADYNOVATE For Hemophilia A Patients With Approval In Japan 4/4/2016
Medtronic (MDT) Snags Expanded Indication for Pillcam Colon 2 3/31/2016
Jazz Pharma (JAZZ) Finally Bags FDA Approval for Rare Liver Disorder Drug Defitelio 3/31/2016
Bio Products Laboratory Receives European Approval For Coagadex (Human Coagulation Factor X) 3/30/2016
Sonendo Wins FDA 510(k) Clearance for the Next-Gen of the GentleWave System 3/29/2016
St. Jude Medical (STJ) Announces CE Mark Approval and Launch of Expanded Selection of Quadripolar Pacing Leads 3/29/2016
Lannett (LCI) Receives FDA Approvals For Two Products 3/29/2016
Great Basin Scientific Wins FDA 510(k) Clearance for First Multiplex Panel 3/28/2016
Anika Therapeutics (ANIK) Wins CE Mark Approval For Cingal For The Treatment Of Pain Associated With Osteoarthritis Of The Knee 3/28/2016
Alexion (ALXN) Release: Kanuma (Sebelipase Alfa) Receives Marketing Approval In Japan For Treatment Of Patients With Lysosomal Acid Lipase Deficiency (LAL-D) 3/28/2016
ZOLL (ZOLL) Receives Approval To Market Intravascular Temperature Management Technology For Sudden Cardiac Arrest In Japan 3/28/2016
Kedrion Receives FDA Approval To Package Koate Double Viral Inactivation (DVI) Antihemophilic Factor (Human) With Mix2Vial Needle-Free Transfer Device 3/28/2016
Bay Area's Intersect ENT Wins FDA Approval of Additional Indication for PROPEL Mini Sinus Implant 3/24/2016
Baxter International (BAX) Completes CE Mark For Expanded Indication Of HEMOPATCH, An Innovative Surgical Patch, In European Union 3/24/2016
Great Basin Scientific Receives FDA 510(k) Clearance for Shiga Toxin Direct Test 3/23/2016
FDA Clears Stimwave's Miniature Peripheral Nerve Stimulator (PNS), Providing The Only Full Body Wireless Pain Relief Solution To Market 3/23/2016
Eli Lilly (LLY) Wins FDA Approval for Psoriasis Drug Taltz 3/23/2016
Teva (TEVA) Announces FDA Approval Of CINQAIR (Reslizumab) Injection 3/23/2016
Aratana Therapeutics (PETX) Granted First FDA Approval 3/22/2016
LEO Pharma Receives Scientific Approval Of Enstilar For The Treatment Of Psoriasis In EU 3/21/2016
Apira Science’s Igrow Becomes First Hair Growth Device Cleared By China Food And Drug Administration (CFDA) 3/21/2016
Horizon Pharma (HZNP) Receives Health Canada Approval For RAVICTI (Glycerol Phenylbutyrate) Oral Liquid For The Treatment Of Urea Cycle Disorders In Patients Two Years Of Age And Older 3/21/2016
Olea Medical Receives FDA Clearance For Olea Sphere 3.0 3/21/2016
Elusys Therapeutics, Inc. Receives FDA Approval For ANTHIM (obiltoxaximab) Injection For The Treatment And Prophylaxis Of Inhalational Anthrax 3/21/2016
Breckenridge Pharmaceutical, Inc. Announces Approval For Gabapentin Oral Solution 3/18/2016
FDA Gives Thumbs Up to Bayer (BAY)'s Hemophilia A Drug Kovaltry 3/17/2016
Merz Pharma Group Announces European Approval Of Bocouture For The Treatment Of Upper Facial Lines 3/17/2016
FDA OKs Expanded Use of Cerus (CERS)'s INTERCEPT Blood System 3/16/2016
FDA Grants Spectrum Pharma (SPPI) Approval Of EVOMELA (Melphalan) For Injection 3/15/2016
Ligand (LGND) Partner Spectrum Pharma (SPPI) Receives FDA Approval Of EVOMELA (Melphalan) For Injection 3/15/2016
Nemaura Medical Announces Receipt Of Notification Of CE Approval For Its Sugarbeat Continuous Glucose Monitoring System 3/15/2016
Intuitive Surgical (ISRG) Wins FDA Approval for New EndoWrist Stapler 3/14/2016
Pfizer (PFE) Release: XALKORI (Crizotinib) Approved By U.S. FDA For The Treatment Of Patients With ROS1-Positive Metastatic Non-Small Cell Lung Cancer 3/14/2016
Vertex (VRTX) Receives Australian 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 3/9/2016
Life Spine Announces FDA Clearance of PROLIFT Expandable Interbody System 3/8/2016
BioStable Announces CE Mark Approval For The HAART 300 Aortic Annuloplasty Device 3/8/2016
FDA Green Lights CSL Behring's Idelvion for Hemophilia B 3/7/2016
Avita Medical Wins FDA Approval for Increase in Compassionate Use of ReCell Patient Cases 3/7/2016
Janssen Biotech Inc. (JNJ) Release: U.S. FDA Approves IMBRUVICA (ibrutinib) For First-Line Treatment Of Chronic Lymphocytic Leukemia 3/7/2016
Gold Standard Diagnostics Receives FDA Clearance for the AIX1000TM System 3/7/2016
Stryker Wins FDA for Tritanium PL Posterior Lumbar Cage 3/4/2016
AstraZeneca PLC (AZN) Release: FDA Approves New Indication For FASLODEX (fulvestrant) 3/3/2016
FDA Green Lights Gilead (GILD)’s Odefsey to Treat HIV-1 Infection in Certain Patients 3/2/2016
Reapplix Snags FDA Approval for Its 3C Patch System 3/1/2016
Becton, Dickinson and Company (BDX) Grabs CE Mark for Next-Gen Blood Separation Technology 3/1/2016
Thermo Fisher Scientific (TMO) Announces Expanded FDA Clearance For Its B·R·A·H·M·S PCT Sepsis Biomarker 3/1/2016
Bristol-Myers Squibb Canada (BMY) Release: Health Canada Approves OPDIVO (nivolumab) For The Treatment Of Advanced Or Metastatic Non-Small Cell Lung Cancer 3/1/2016
CoorsTek Medical Announces FDA 510(K) Clearance For Total Hip System Incorporating Cerasurf-P Implantable Ceramic Components 3/1/2016
FDA Approves New Indication For Novartis Pharmaceuticals Corporation (NVS) Drug Afinitor For Progressive, Nonfunctional GI And Lung Neuroendocrine Tumors (NET) 2/29/2016
EOS Imaging Receives CE Mark For Spineeos Online 3D Surgical Planning Solution For The EOS System 2/29/2016
FDA Green Lights Genentech (RHHBY)'s Gazyva for Patients with Previously Treated Follicular Lymphoma 2/26/2016
Allergan (AGN) Announces FDA Approval Of ACZONE (dapsone) Gel, 7.5% For Treatment Of Acne Vulgaris 2/26/2016
Teligent Announces FDA Approval Of Desoximetasone Ointment USP 0.25% 2/26/2016
Roche Canada Release: New Targeted Therapy For Treatment Of Serious Form Of Skin Cancer Approved In Canada 2/25/2016
IntelliPharmaCeutics Announces FDA Approval For 500 Mg And 750 Mg Generic Keppra XR® 2/25/2016
SHINE Medical Technologies Receives Regulatory Approval: Nuclear Regulatory Commission To Issue Construction Permit 2/25/2016
ANI Pharma And Dexcel Pharma Announce FDA Approval Of Donepezil Hydrochloride 23mg Tablets 2/24/2016
Pfizer (PFE) Announces FDA Approval Of XELJANZ® XR (Tofacitinib Citrate) Extended-Release Tablets, The First And Only Once-Daily Oral JAK Inhibitor Treatment For Rheumatoid Arthritis 2/24/2016
FDA Panel Votes Against Approval Medtronic (MDT)'s Spine Implant 2/23/2016
Boston Scientific (BSX) Bags CE Mark for Eluvia Peripheral Stent 2/22/2016
Lannett (LCI) Receives FDA Approval For Sumatriptan Nasal Spray USP, 5mg And 20mg 2/22/2016
Vericel (ASTM) Announces FDA Approval Of Epicel HDE Supplement 2/22/2016
U.S. FDA Approves UCB Group (UCBJF.PK)'s New Epilepsy Treatment, BRIVIACT, For Patients With Partial-Onset Seizures 2/22/2016
Mitralign, Inc. Percutaneous Annuloplasty System Earns CE Mark Approval for Functional Mitral Regurgitation 2/22/2016
Pfizer (PFE) Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer 2/22/2016
ScandiDos Wins FDA Approval for Delta4 Discover in U.S. 2/19/2016
FDA Approves Medtronic (MDT)'s DBS Therapy for Parkinson's Patients 2/17/2016
FDA Green Lights Masimo (MASI)'s Root with Noninvasive Blood Pressure and Temperature 2/17/2016
Z-Medica Snags Expanded CE Mark for QuikClot 2/17/2016
St. Jude Medical (STJ) Wins FDA Approval for Its Axium Neurostimulator System for Pain 2/17/2016
FDA OKs Two Supplemental Indications for Gilead (GILD)'s Harvoni 2/16/2016
IRIDEX (IRIX) Wins CE Mark for Cyclo G6 Laser System for the Treatment of Multiple Stages of Glaucoma 2/16/2016
Cutera, Inc. (CUTR) Announces Additional Country Regulatory Clearances For enlighten 2/15/2016
Wenzel Spine Snags FDA Approval to Launch VariLift-LX 2/11/2016
Lannett (LCI) Receives FDA Approval For Temozolomide Capsules 2/11/2016
LifeWatch Wins FDA Approval for Its Continuous Vital Signs Monitoring Service 2/9/2016
CorMatrix Cardiovascular Snags FDA Nod for Its Tyke Implantable Device For Neonate And Infant Cardiac Tissue Repair 2/9/2016
Promius Pharma, LLC Receives FDA Approval For Sernivo (Betamethasone Dipropionate) Spray, 0.05% 2/8/2016
U.S. FDA Approves Expanded Use Of Bristol-Myers Squibb’s Daklinza(Daclatasvir) For Additional Challenging-To-Treat Patients With Genotype 1 Or Genotype 3 Chronic Hepatitis C 2/8/2016
Medtronic (MDT) First to Win FDA Approval for MR-Conditional Cardiac Resynchronization Therapy-Defibrillators 2/5/2016
Abbott (ABT) Scores CE Mark for Freestyle Libre Flash for Kids 2/5/2016
FDA Approves Merck & Co. (MRK)'s Single-Dose EMEND (Fosaprepitant Dimeglumine) For Injection, In Combination With Other Antiemetic Agents, For The Prevention Of Delayed Nausea And Vomiting In Adults Receiving Moderately Emetogenic Chemotherapy (MEC) 2/4/2016
Dr. Reddy's Laboratories Ltd. (RDY) Receives FDA Approval For ZEMBRACE Symtouch (sumatriptan succinate) Injection For The Acute Treatment Of Migraines In Adults 2/3/2016
Bayer (BAY) Release: Health Canada Approves New Treatment Option For Canadian Adults and Children Living with Hemophilia A 2/3/2016
Teligent Announces FDA Approval Of Lidocaine Ointment USP 5% 2/2/2016
FDA Approves AVANIR (AVNR) New Migraine Treatment With Unique Inhalant Delivery System 2/1/2016
FDA Approves Eisai Inc. (ESALF.PK)'s Halaven (eribulin mesylate) Injection For The Treatment Of Patients With Advanced Liposarcoma 1/29/2016
Servier Canada Inc. Release: Viacoram Now Approved In Canada As A New First Line Treatment In Hypertension 1/29/2016
Dr. Reddy's Laboratories Ltd. (RDY) Receives FDA Approval For ZEMBRACE Symtouch (Sumatriptan Succinate) Injection For The Acute Treatment Of Migraines In Adults 1/29/2016
OptiNose AS Announces FDA Approval For ONZETRA Xsail (Sumatriptan Nasal Powder), A New Treatment For Acute Migraine Using Bi-Directional Breath Powered Technology 1/29/2016
European Commission Approves Daklinza (Daclatasvir) For The Treatment Of Genotype 1, 3 And 4 Chronic Hepatitis C Patients With HIV Coinfection, Advanced Cirrhosis And Post-Liver Transplant Recurrence Of HCV 1/29/2016
Market Just Got More Crowded as Merck & Co. (MRK)'s New Hepatitis C Drug Wins FDA Approval 1/29/2016
Health Canada Approves Amgen (AMGN)'s New Multiple Myeloma Treatment Kyprolis (carfilzomib) 1/28/2016
Neos Therapeutics (NEOS) Announces FDA Approval Of Adzenys XR-ODT (Amphetamine Extended-Release Orally Disintegrating Tablet) For The Treatment Of ADHD In Patients 6 Years And Older 1/28/2016
FDA Green Lights SonarMed's Device for Monitoring Newborns 1/28/2016
Vertex (VRTX) Release: Health Canada Approves PrORKAMBI (Lumacaftor/Ivacaftor) - The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis For People Ages 12 And Older With Two Copies Of The F508del Mutation 1/27/2016
FDA Approves Takeda (TKPYY)'s Dexilant SoluTab (dexlansoprazole) 1/27/2016
Dako (A) Snags Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma 1/25/2016
entrotech life sciences Release: ChloraDerm Antimicrobial Transparent Film Dressing Receives FDA Clearance For 7-Day Catheter Site Protection Against MRSA And Other Infection-Related Organisms 1/25/2016
Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab) + Yervoy (Ipilimumab) Regimen Receives Expanded FDA Approval In Unresectable Or Metastatic Melanoma Across BRAF Status1 1/25/2016
FDA Grants Full Approval for Amgen (AMGN)'s Blood Cancer Drug 1/25/2016
Amgen (AMGN)'s Repatha (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol 1/22/2016
K2M Wins CE Mark for Its Next-Gen RHINE Cervical Disc System 1/22/2016
Allergan (AGN) Release: U.S. FDA Approves BOTOX (onabotulinumtoxinA) For The Treatment Of Lower Limb Spasticity In Adults 1/22/2016
Takeda (TKPYY) Release: European Commission (EC) Approves Label Variation For ADCETRIS (Brentuximab Vedotin) To Include Data On Retreatment Of Adult Patients With Relapsed Or Refractory Hodgkin Lymphoma And Systemic Anaplastic Large Cell Lymphoma (sALCL) 1/22/2016
Allergan (AGN) Announces FDA Approval Of Updated Label For New Dosing Regimen For DALVANCE (dalbavancin) 1/21/2016
University Of Maryland School Of Medicine Research Leads To FDA Approval Of Crucial Drug For Radiation Sickness 1/21/2016