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Clinical - Approvals
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
FDA Green Lights SonarMed's Device for Monitoring Newborns 1/28/2016
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
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
FDA Grants Full Approval for Amgen (AMGN)'s Blood Cancer Drug 1/25/2016
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
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
Pelvalon Wins FDA Nod for Second-Gen Non-Surgical Therapy for Women Suffering from Loss of Bowel Control 1/21/2016
NextSource Biotechnology Gains FDA Approval For New 5 Mg Strength Of Gleostine (Lomustine), An Anti-Cancer Chemotherapy Agent 1/20/2016
Novartis AG (NVS) Wins Two New FDA Approvals for Cosentyx 1/19/2016
W. L. Gore & Associates Release: Unique Biomaterial For Hernia Repair Receives FDA 510K Clearance 1/19/2016
AtriCure (ATRC) Announces Approval For The Atriclip In Japan 1/19/2016
Medical Device Firm Advanced Cooling Therapy Receives 510(K) Clearance From FDA For Second Esophageal Cooling Device To Cool And Warm Patients 1/19/2016
HealthMyne Announces FDA Clearance Of Imaging Analytics Package 1/19/2016
LifeWatch Corp Granted FDA Approval for its Mobile Cardiac Telemetry 1-Lead Patch 1/18/2016
Biogen (BIIB) Release: BENEPALI,The First Etanercept Biosimilar Referencing Enbrel, Approved In The European Union 1/18/2016
IMPAX Labs (IPXL) Receives Approval Of EMVERM (Mebendazole) Chewable Tablets, 100 Mg 1/15/2016
Soterix Medical Launches PainX tDCS Treatment in EU with CE Approval 1/15/2016
Oculus Innovative Sciences, Inc. (OCLS) Wins CE Mark for New MucoClyns for First Responders 1/14/2016
FDA Clears Siemens (SI)’ New High-Volume Coagulation Analyzer 1/13/2016
Medtronic (MDT) Wins FDA Approval for OsteoCool RF Ablation System 1/13/2016
Simplot Release: Innate Second Generation Potato Receives FDA Safety Clearance 1/13/2016
Janssen Inc. Release: Health Canada Approves Stelara As First Biologic In North America For The Treatment Of Moderate-To-Severe Psoriasis In Adolescents 1/13/2016
Health Canada Approves Amgen (AMGN)'s BLINCYTO (blinatumomab) For The Treatment Of Relapsed Or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia 1/12/2016
K2M Expands Minimally Invasive Spine Portfolio With Addition Of Its CASCADIA Lateral Interbody System Featuring Lamellar Titanium Technology 1/8/2016
Vivasure Medical Receives CE Mark For First And Only Fully Bioabsorbable Percutaneous Closure Device For Large-Bore Transcatheter Procedures 1/8/2016
Acerus (TRLPF) Receives Health Canada Approval For NATESTO 1/8/2016
AbbVie (ABBV)'s HUMIRA (Adalimumab) Receives First And Only Health Canada Approval For Moderate To Severe Hidradenitis Suppurativa 1/6/2016
MEDTECH Receives FDA Clearance for ROSA Spine 1/6/2016
RPS Diagnostics Announces Canadian Approval Of Febridx Test To Help Rapidly Differentiate Viral From Bacterial Acute Respiratory Infection At The Point Of Care 1/6/2016
NeuroMetrix (NURO) Announces FDA 510(K) Clearance Of Next Generation Quell® Wearable Pain Relief Technology At The 2016 Consumer Electronics Show 1/6/2016
Bay Area's NuCryo Vascular Wins 510(k) Clearance for Next-Gen Reusable Cryoplasty Inflation Device 1/5/2016
United-Guardian Receives FDA Approval To Market New Single-Dose Form Of Renacidin 1/4/2016
Hikma (HIK.L) Receives FDA Approval For Neostigmine Methylsulfate Injection 1/4/2016
FDA Clears FUJIFILM Reprocessing Label For "Superbug"-Susceptible Duodenoscopes 12/30/2015
Avedro CEO Resigns; Pharma Device Maker Snags CE Mark Clearance for its Mosaic Advanced Cross-Linking System 12/29/2015
Eagle Pharma (EGRX), Teikoku Pharma Win FDA Approval of Docetaxel Injection, First and Only Alcohol-Free Formulation 12/28/2015
FDA Approves Merz North America's XEOMIN for Treatment of Adult Upper Limb Spasticity 12/23/2015
FDA Greenlights AstraZeneca PLC (AZN)'s Gout Drug Zurampic 12/23/2015
Actelion (ALIOF.PK)'s Uptravi Received FDA Approval, to Enter U.S. Market in January 12/23/2015
Sanofi Pasteur (SASY.PA)'s Dengue Vaccine Approved in the Philippines 12/22/2015
BiondVax Pharmaceuticals Approval For A Patent For Its Universal Flu Vaccine In Israel 12/21/2015
FDA Approves Expanded Indication For Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) For The Treatment Of Patients With Advanced Melanoma 12/21/2015
Baxalta (BXLT) Release: Technology Transfer Success At The MDC: U.S. Approval For New Bleeding Disorder Drug 12/21/2015
Celgene (CELG) Release: Oral REVLIMID Plus Dexamethasone Granted Approval For Treatment Of Patients With Newly Diagnosed Multiple Myeloma In Japan 12/21/2015
European Commission (EC) Approves Amgen (AMGN)'s IMLYGIC (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe 12/18/2015
GI Logic Grabs FDA Approval for the AbStats System for Real-Time Digestive Telemetry 12/18/2015
PURE Bioscience (PURE) Receives FDA Approval For Use Of SDC Antimicrobial As Poultry Processing Aid To Reduce Pathogens, Including Salmonella 12/18/2015
Merck & Co. (MRK)’s BRIDION (Sugammadex) Receives FDA Approval For The Reversal Of Neuromuscular Blockade Induced By Rocuronium And Vecuronium In Adults Undergoing Surgery 12/18/2015
FDA Approves ZOLL (ZOLL)'s Wearable Defibrillator for Kids 12/18/2015
FDA Clears Eli Lilly (LLY)'s Diabetes Drug Basaglar 12/17/2015
ANI Pharma Announces FDA Approval Of Polyethylene Glycol 3350 Powder For Oral Solution, 17mg/Scoopful 12/17/2015
Bio-Rad (BIO) Wins FDA Approval for Its D-100 System for A1c Testing 12/17/2015
Tris Pharma, Inc. Announces First Ever FDA-Approved Extended-Release Chewable Tablet 12/16/2015
Celsion (CLSN) Receives CFDA Approval To Conduct The OPTIMA Study In China 12/16/2015
K2M Grabs FDA Approval for EVEREST Minimally Invasive XT Spinal System 12/16/2015
Merck & Co. (MRK) Release: FDA Approves Expanded Age Indication For GARDASIL 9 In Males 12/16/2015
Swissmedic Approves Akynzeo (netupitant/palonosetron) For Use In The Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV) In Switzerland 12/15/2015
Lightlake (LLTP) Receives Milestone Payment For U.S. FDA Approval Of NARCAN (Naloxone Hydrochloride) Nasal Spray 12/15/2015
Svelte Medical Snags CE Mark Certification of SLENDER IDS 12/15/2015
FDA Green Lights Otonomy (OTIC)'s First-of-Its-Kind Ear Drug Otiprio 12/14/2015
BTG plc (BTG.L) Wins FDA Approval for LC Bead LUMI, the First Commercially Available Radiopaque Embolic Bead in the U.S. 12/14/2015
Antares Pharma, Inc. (ATRS) Announces FDA Approval Of Sumatriptan Injection USP 12/14/2015
BTG plc (BTG.L) Announces FDA Approval Of VISTOGARD (Uridine Triacetate) As Antidote To Overdose And Early Onset, Severe, Or Life-Threatening Toxicities From Chemotherapy Drugs 5-Fluorouracil (5-FU) Or Capecitabine 12/14/2015
Chugai Pharmaceutical Co., Ltd. (Japan)'s ALK Inhibitor "Alecensa" Accelerated Approval In Three Months After Priority Review Designation In The US 12/14/2015
Genentech (RHHBY) Wins Accelerated Approval for Alecensa to Treat Specific Lung Cancer Patients 12/14/2015
Teligent, Inc. Announces FDA Approval Of CEFOTAN (cefotetan) For Injection 12/11/2015
RevMedx's Device That Plugs Gunshot Wounds in 20 Seconds Just Got FDA Approval 12/11/2015
EDAP TMS (EDAP) Receives Russian Regulatory Approval For Focal One HIFU Device 12/11/2015
Endologix AFX Endovascular AAA System Receives Shonin Approval For Marketing In Japan 12/11/2015
Sanofi Pasteur (SASY.PA) to Launch World's First Dengue Vaccine in Mexico 12/10/2015
Sinovac Biotech Ltd. (SVA) Obtains Clinical Trial Approval For Sabin-IPV Candidate 12/10/2015
CareFusion Wins Approval for Two Spine Products 12/10/2015
FDA Gives Nod to Baxalta (BXLT)'s Rare Bleeding Disorder Drug Vonvendi 12/9/2015
Pfizer (PFE) Receives U.S. FDA Approval Of New Quillichew ER (Methylphenidate Hydrochloride) Extended-Release Chewable Tablets CII 12/9/2015
Medtronic (MDT) Wins Approval for the Only Full-Body MR Conditional DBS 12/9/2015
Stimwave Wins FDA Nod and Launches Commercialization for World’s Smallest Fully-Programmable, Eight-Electrode Wireless Pain Relief SCS System 12/9/2015
Cerus (CERS) Announces Agência Nacional De Vigilância Sanitária Approval Of The INTERCEPT Blood System For Platelets And Plasma In Brazil 12/9/2015
Alexion (ALXN) Release: Adding Multimedia FDA Approves Kanuma (Sebelipase Alfa) For The Treatment Of Patients With Lysosomal Acid Lipase Deficiency (Lal-D) 12/9/2015
Alexion (ALXN) Release: FDA Approves Kanuma (Sebelipase Alfa) For The Treatment Of Patients With Lysosomal Acid Lipase Deficiency (LAL-D) 12/8/2015
Teva (TEVA) And Eagle Pharmaceuticals (EGRX) Announce FDA Approval Of BENDEKA (bendamustine hydrochloride) Injection 12/8/2015
Royal DSM Receives FDA 510k Clearance For Dyneema Purity Radiopaque Cerclage Cable For Use In Orthopedic Trauma 12/8/2015
Cipher Pharma (DND.TO) Receives Health Canada Approval Of (Pr)Beteflam 12/7/2015
Merck & Co. (MRK) Announces Samsung Bioepis Receives Approval Of RENFLEXIS (Infliximab), A Biosimilar Of Remicade, In Korea 12/7/2015
Samsung Bioepis' RENFLEXIS Infliximab Biosimilar Receives Regulatory Approval in Korea 12/4/2015
PORTRAZZA (Necitumumab) Approved As First-Line Therapy For Metastatic, Squamous Non-Small Cell Lung Cancer, Available At Biologics, Inc. (NC) 12/3/2015
Alcresta Receives FDA Clearance For RELiZORB 12/2/2015
St. Jude Medical (STJ) Wins CE Mark for MRI Compatibility on Quadra Assura CRT-D to Improve Access to Diagnostic Imaging for Heart Failure Patients 12/2/2015
Bristol-Myers Squibb (BMY) And AbbVie (ABBV) Receive FDA Approval Of Empliciti (Elotuzumab) For The Treatment Of Patients With Multiple Myeloma Who Have Received One To Three Prior Therapies 12/1/2015
Greatbatch (GB) Receives FDA Approval of Algovita Spinal Cord Stimulation System 12/1/2015
Eisai And Toyama Chemical Clear All-Case Surveillance Condition For Approval Of Antirheumatic Agent Iguratimod 12/1/2015
Enzymotec's Incog, An Innovative Lipid Composition For Cognitive Functioning, Approved As Novel Food In Europe 12/1/2015
Caputron Medical Announces FDA Cleared Mindgear Treatment For Depression, Insomnia And Anxiety 12/1/2015
Horizon Pharma (HZNP) Receives European Commission (EC) Approval For RAVICTI (Glycerol Phenylbutyrate) Oral Liquid For The Treatment Of Urea Cycle Disorders In Patients Two Months Of Age And Older 12/1/2015
Oticon Medical Gains FDA Clearance For Two New Offerings: Minimally Invasive Ponto Surgery (MIPS) And Ponto BHX Implant 12/1/2015
Siemens (SI) Wins FDA Approval for Multitom Rax Robotic X-ray System 11/30/2015
FDA Green Lights St. Jude Medical (STJ)'s Proclaim Elite Spinal Cord Stimulator for Chronic Pain 11/30/2015
Boehringer Ingelheim And Eli Lilly Canada Inc. (LLY) Release: Health Canada Approves JARDIANCE (empagliflozin) Tablets For Adults With Type 2 Diabetes 11/30/2015
Boehringer Ingelheim Release: Praxbind (Idarucizumab) Approved In European Union For The Specific Reversal Of Pradaxa (Dabigatran Etexilate) 11/30/2015
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
Eli Lilly (LLY)'s New Cancer Drug Portrazza Wins FDA Approval 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
Cumberland Pharmaceuticals (CPIX) Release: Caldolor Approved For Use In Pediatric Patients 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
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
Moximed Wins CE Mark and First Commercial Use of AtlasTM Knee System 11/18/2015
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
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 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