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Clinical - Approvals
Bayer HealthCare (BAY) and Foamix Pharmaceuticals, Ltd. (FOMX) Release: Finacea (Azelaic Acid) Foam 15%, Approved By U.S. FDA For Topical Treatment Of The Inflammatory Papules And Pustules Of Mild To Moderate Rosacea 7/31/2015
FDA Approves Bayer HealthCare (BAY)'s Finacea (Azelaic Acid) Foam, 15% For The Topical Treatment Of The Inflammatory Papules And Pustules Of Mild To Moderate Rosacea 7/31/2015
Roche (RHHBY)’s Perjeta Regimen Approved In Europe For Use Before Surgery In Early Stage Aggressive Breast Cancer 7/31/2015
Teleflex Incorporated (TFX) Release: ARROW Endurance Extended Dwell Peripheral Catheter System Receives FDA Market Clearance 7/30/2015
Glaukos Receives Regulatory Approval In Australia For Istent Inject 7/30/2015
Japanese Approval Trial For Stress Urinary Incontinence Using Cytori Therapeutics, Inc. (CYTX) Cell Therapy Announced 7/30/2015
NeuWave Medical Wins FDA Nod for Ablation Confirmation Software 7/30/2015
EMBA Medical Limited Awarded CE Certificate For Hourglass Peripheral Embolization Plug 7/29/2015
Corvida Medical Receives FDA 510 Clearance for Halo Closed System Transfer Device 7/29/2015
Breckenridge Pharmaceutical, Inc. Announces Approval For Azelastine HCl Nasal Solution (Nasal Spray) 7/29/2015
Bay Area's C2 Therapeutics Wins FDA Nod for the Coldplay Cryoballoon Full and Swipe Ablation Systems 7/29/2015
FDA Green Lights ReShape Medical's Weight Loss Stomach Balloon 7/29/2015
Juniper Pharmaceuticals Announces Regulatory Approvals For CRINONE Progesterone Gel In Nine New EU Countries 7/28/2015
ANI Pharma And Sofgen Pharmaceuticals Announce FDA Approval Of Nimodipine 30mg Capsules 7/27/2015
Bristol-Myers Squibb (BMY) Release: FDA Approves Daklinza (Daclatasvir) For The Treatment Of Patients With Chronic Hepatitis C Genotype 3 7/27/2015
Amgen (AMGN) Release: FDA Approves Kyprolis (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma 7/24/2015
FDA Approves Cholesterol Drug Praluent From Regeneron (REGN), Sanofi (SNY) 7/24/2015
Bristol-Myers Squibb (BMY) Release: FDA Approves Daklinza (Daclatasvir) For The Treatment Of Patients With Chronic Hepatitis C Genotype 3 7/24/2015
Enanta Pharmaceuticals, Inc. Announces U.S. Regulatory Approval Of TECHNIVIE (Ombitasvir, Paritaprevir And Ritonavir) Tablets 7/24/2015
TECHNIVIE (ombitasvir, paritaprevir, and ritonavir tablets) Receives FDA Approval As The First And Only All-Oral, Interferon-Free Treatment For Genotype 4 Chronic Hepatitis C In The U.S. 7/24/2015
FDA Approves Novartis AG (NVS) Drug Odomzo (sonidegib) For Locally Advanced Basal Cell Carcinoma (laBCC), A Form Of Skin Cancer 7/24/2015
Amgen (AMGN) Beats Sanofi (SNY)/Regeneron (REGN) to European Market for Cholesterol Drug, but Race is Still on for U.S. Market 7/23/2015
Medrobotics Receives FDA Clearance To Market Flex Robotic System 7/23/2015
Theravance (THRX) Announces Health Canada Approval For VIBATIV (telavancin) for Treatment of HAP/VAP Caused By Gram-Positive Bacteria, Including MRSA 7/23/2015
European Commission (EC) Approves Merck & Co. (MRK)'s Anti-PD-1 Therapy, KEYTRUDA (Pembrolizumab), For Both First-Line And Previously-Treated Patients With Advanced Melanoma 7/22/2015
European Commission (EC) Approves Amgen (AMGN)s New Cholesterol-Lowering Medication Repatha (Evolocumab), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholesterol 7/21/2015
Bristol-Myers Squibb (BMY) Release: European Commission (EC) Approves Nivolumab BMS, The First PD-1 Immune Checkpoint Inhibitor In Europe Proven To Extend Survival For Patients With Previously-Treated Advanced Squamous Non-Small Cell Lung Cancer 7/20/2015
Galderma Canada Release: Novel Rosacea Treatment Approved By Health Canada For Adult Patients 7/20/2015
Meridian Bioscience (VIVO) Snags FDA OK for New Molecular Amplification Test: illumigene HSV 1&2 7/20/2015
BioSpecifics Technologies Corporation (BSTC) Announces Approval Of XIAFLEX In Japan For The Treatment Of Dupuytren's Contracture 7/20/2015
St. Jude Medical (STJ) Snags FDA Nod for Industry's Only MR-Conditional 5-Column Paddle Lead for the Management of Chronic Pain 7/20/2015
Ipsen (IPN.PA) Announces FDA Approval Of Dysport(Abobotulinumtoxina) For Injection In The Treatment Of Upper Limb Spasticity In Adults In The United States 7/17/2015
Galderma Laboratories Receives FDA Approval For New Antibiotic-Free Treatment Option For Acne Patients 7/17/2015
Novo Nordisk A/S (NVO) Receives FDA Approval For FlexPro PenMate For People With Growth Hormone-Related Disorders 7/16/2015
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s Evotaz (Atazanavir And Cobicistat Fixed-Dose Combination) For The Treatment Of HIV-1 Infection In Adults 7/16/2015
St. Jude Medical (STJ) Receives FDA Approval For The Industry's First Spinal Cord Stimulation Trial System To Incorporate Bluetooth® Wireless Technology And Apple Digital Devices 7/16/2015
Summit Medical Nears Completion Of 510(K) Goals With FDA Clearance For Additional Sterilization Cycles 7/15/2015
Merz Pharma Canada Ltd. Announces The Approval Of Radiesse (+) With Integral 0.3% Lidocaine 7/15/2015
FDA Green Lights AstraZeneca PLC (AZN)'s Lung Cancer Drug Iressa 7/14/2015
Otsuka Pharma, H. Lundbeck A/S (LUN.CO) Beat Competitors With FDA Approval of Schizophrenia Drug 7/13/2015
FDA Clearance For joimax Endolif On-Cage: 3D-Printed Fusion Implant 7/13/2015
Veloxis Pharmaceuticals A/S (VELO) Announces U.S. FDA Approval of Envarsus XR For Treatment Of Kidney Transplant Patients 7/13/2015
AbbVie (ABBV) Release: IMBRUVICA (ibrutinib) Now Approved To Treat Waldenstrom's Macroglobulinemia In Europe 7/10/2015
Novartis AG (NVS) Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20% 7/9/2015
IGI Laboratories, Inc. Announces FDA Approval And Commercial Launch Of Diclofenac Sodium, 1.5% 7/9/2015
B.Braun Medical Wins FDA Approval for 70% Dextrose Injection, USP 7/9/2015
COPD Foundation Release: FDA Approves First COPD Biomarker: Paving Way For New, Improved Treatments And Cures 7/9/2015
Lexmark Healthcare Receives FDA 510(k) Class II Clearance For NilRead Enterprise Viewer 7/9/2015
Protein Sciences Corporation Receives Approval from FDA For 2015/16 Formulation Of Flublok Influenza Vaccine 7/8/2015
Vanda Pharmaceuticals, Inc. (VNDA) Release: HETLIOZ Receives European Commission Approval For The Treatment Of Non-24-Hour Sleep-Wake Disorder In The Totally Blind 7/8/2015
Novartis AG (NVS)' New Heart Failure Medicine LCZ696, Now Called Entresto(TM), Approved By FDA To Reduce Risk Of Cardiovascular Death And Heart Failure Hospitalization 7/8/2015
Vertex (VRTX) Gets FDA Approval for $259K Per Year CF Drug 7/7/2015
Easton Pharmaceuticals (OP: EAPH) / BMV Medica Announces Its Mexican Ministry Of Health And Latin America Regulatory Filing And Approval Process For Cancer Drugs Paclitaxel And Docetaxel From Biolyse Pharma Has Been Shortened 7/7/2015
Japan’s Ministry Of Health, Labour And Welfare Approves Gilead (GILD)’s Harvoni, The First Once-Daily Single Tablet Regimen For The Treatment Of Genotype 1 Chronic Hepatitis C 7/6/2015
Alexion (ALXN) Release: Strensiq (asfotase alfa) Receives Marketing Approval In Japan For Treatment Of Patients With Hypophosphatasia (HPP) 7/6/2015
Kubtec Announces FDA Approval of DIGIVIEW 395 High Resolution Wireless Flat Panel Detector 7/6/2015
Vertex (VRTX) Release: FDA Approves ORKAMBI (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 7/6/2015
Boehringer Ingelheim Release: New Advance In COPD Maintenance Treatment, Spiolto Respimat, Approved In First European Countries 7/2/2015
Proteus Digital Health Release: First Medical Device Cleared By FDA With Adherence Claim 7/2/2015
Galderma Receives FDA Approval To Market Restylane Lyft With Lidocaine To Correct Age Related Volume Loss In The Cheek Area 7/2/2015
GlySure Secures CE Mark And Launches World’s First Continuous Intravascular Glucose Monitoring System 7/1/2015
Spriaso Announces Approval Of New Drug Application For The Long Acting Codeine Antitussive With A Popular Anti-Histamine 7/1/2015
New Indication For Teijin Pharma’s Febuxostat In Europe 6/30/2015
SpineGuard Obtains Regulatory Clearance To Sell Pediguard In The World’s Second-Largest Spine Market: China 6/30/2015
Swedish Orphan Biovitrum Release: European Commission (EC) Approves Orfadin Oral Suspension 6/29/2015
Caldera Medical Announces FDA Clearance For New Generation Of Vertessa Lite Polypropylene Mesh For Sacrocolpopexy 6/29/2015
Exactech (EXAC) Grabs FDA Approval for Its Optetrak Logic Constrained Condylar Prosthesis 6/29/2015
Merck & Co. (MRK) Release: SIMPONI Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis 6/26/2015
Regeneron (REGN) Release: EYLEA (aflibercept) Injection Receives Approval In Japan For The Treatment Of Retinal Vein Occlusion 6/26/2015
FDA Approves The Medicines Company (MDCO)'s Blood Clot Drug KENGREAL 6/24/2015
Wockhardt (WOCKHARDT.BO) Receives ANDA Approval For Pain Medication Oxycodone Liquid 6/22/2015
Amphastar Pharmaceuticals, Inc. (AMPH) Receives Approval For AMPHADASE Supplement, Marking The First Product From Its China Facility 6/22/2015
FDA Green Lights Eisai Inc. (ESALF.PK)'s FYCOMPA for Adjunctive Therapy in the Treatment of Primary Generalized Tonic-Clonic Seizures in Patients with Epilepsy Age 12 and Older 6/22/2015
European Commission (EC) Approves Bristol-Myers Squibb (BMY)’s Opdivo (Nivolumab), The First And Only PD-1 Checkpoint Inhibitor Approved In Europe, For Both First-Line And Previously-Treated Advanced Melanoma Patients 6/19/2015
Admedus Granted Cardiocel Approval In Singapore 6/18/2015
IMPAX Labs (IPXL) Release: FDA Approves ZOMIG (zolmitriptan) Nasal Spray For Migraine In Pediatric Patients (Ages 12-17) 6/16/2015
Ligand Pharmaceuticals Inc. (LGND) Release: FDA Approves Promacta For New Pediatric Chronic Immune Thrombocytopenia (Citp) Indication 6/12/2015
Novartis AG (NVS) Gains FDA Approval For Promacta Providing New Option For Children, Ages 6 And Older, With Chronic ITP, A Rare Blood Disorder 6/12/2015
Merz North America Announces FDA Approval Of Radiesse For Use In The Hands 6/5/2015
FDA Green Lights NovaBay (NBY)’s New High-Tech Device intelli-Case 6/4/2015
TWi Pharmaceuticals, Inc. Receives U.S. FDA Final Approval On Generic Guanfacine HCl ER Tablet 6/3/2015
Valeant (VRX) Release: RELISTOR Receives European Approval For Expanded Indication To Treat All Opioid-Induced Constipation 6/3/2015
ANI Pharmaceuticals, Inc. Announces FDA Approval Of Oxycodone Hydrochloride Oral Solution 5mg/5ml 6/2/2015
Hospira Release: ANVISA Approves First Infliximab Biosimilar In Brazil 6/2/2015
The European Commission (EC) Approves Helsinn's Akynzeo (netupitant/palonosetron) for the Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV) In The European Union 6/2/2015
Actavis (ACT) And Perrigo (PRGO) Receive FDA Approval Of Guaifenesin/Pseudoephedrine, The Store Brand Equivalent To Mucinex D Tablets 6/2/2015
Upsher-Smith Laboratories Release: FDA Approves Expanded Indication For Qudexy XR (Topiramate) Extended-Release Capsules Within The Pediatric Population 6/1/2015
Rapamune, Pfizer (PFE)'s Branding-Troubled Drug, Gets FDA Approval for Rare Lung Disease 5/29/2015
Actavis (ACT), Valeant (VRX) Win FDA Approval for VIBERZI to Treat IBS With Diarrhea 5/28/2015
MYOS (MYOS) Receives Health Canada Approval Of Proprietary Ingredient Fortetropin 5/28/2015
Boehringer Ingelheim Release: Type 2 Diabetes: Synjardy (Empagliflozin/Metformin Hydrochloride) Approved In The European Union 5/28/2015
Salix (SLXP) Announces FDA Approval of Xifaxan 550 mg For The Treatment Of IBS-D (Irritable Bowel Syndrome With Diarrhea) 5/28/2015
Otsuka Pharmaceutical Co., Ltd.’s JINARC The First-Ever Treatment Approved In Europe For Adults Living With ADPKD, A Chronic Genetic Kidney Disease 5/27/2015
Helsinn Group Release: The European Commission (EC) Approves ALOXI (palonosetron HCl) Injection To Prevent Nausea And Vomiting Due To Chemotherapy In Children As Young As One Month 5/27/2015
Eli Lilly (LLY) Release: U.S. FDA Approves Humalog 200 units/mL KwikPen 5/27/2015
Boehringer Ingelheim Grabs FDA Approval for Next-Gen COPD Drug 5/26/2015
VentriPoint Diagnostics Wins Marketing Clearance From the FDA to Expand the Use of the VMS Heart Analysis System 5/26/2015
Janssen Pharmaceuticals, Inc. Release: U.S. FDA Approves INVEGA TRINZA, First and Only Four-Times-A-Year Treatment For Schizophrenia 5/19/2015
Baxter International (BAX) Receives U.S. FDA Approval for 0.9% Sodium Chloride Injection, USP From Sabinanigo, Spain, Facility For The U.S. Market 5/18/2015
Pernix (PTX) Release: FDA Approves TREXIMET (Sumatriptan And Naproxen Sodium) For Use In Pediatric Patients 5/15/2015
LabStyle Innovations Receives Health Canada Approval For Commercialization Of The Dario Diabetes Management Solution 5/14/2015
Nova Laboratories Release: FDA Approves First Aseptically Spray Dried Biologic 5/14/2015
Specialised Therapeutics Australia Release: TGA Approves AKYNZEO(R) (netupitant/palonosetron) For The Prevention Of Chemotherapy-Induced Nausea And Vomiting (CINV) 5/8/2015
GlaxoSmithKline (GSK) Slips as FDA Approves Asthma Drug for Adults, Not Younger Patients 5/5/2015
Bayer AG (BAYZF) Adds Two Indications In China For Anticoagulant Xarelto 5/5/2015
Kythera (KYTH) Grabs FDA Approval for Chin Fat-Busting Drug 5/4/2015
Vernalis PLC (VNLPY.PK) And Tris Pharma, Inc. Receive FDA Approval Of NDA For Tuzistra XR (Codeine Polistirex And Chlorpheniramine Polistirex) 5/1/2015
GlaxoSmithKline (GSK) Release: FDA Approves BREO ELLIPTA For The Treatment Of Adults With Asthma In The US 5/1/2015
The Medicines Company (MDCO) Announces FDA Approval Of IONSYS (Fentanyl Iontophoretic Transdermal System) For The Management Of Acute Post-Operative Pain For Adult Patients In The Hospital 5/1/2015
The Medicines Company (MDCO) Announces FDA Approval Of RAPLIXA (Fibrin Sealant), The First And Only Powdered Fibrin Sealant Ready-To-Use For Mild To Moderate Surgical Bleeding 5/1/2015
Kythera (KYTH) Announces FDA Approval Of KYBELLA (Also Known As ATX-101) 4/30/2015
Emergent BioSolutions (EBS) Expands Commercial Product Portfolio With FDA Approval Of IXINITY, A Recombinant Factor IX Treatment For Hemophilia B 4/30/2015
Breckenridge Pharmaceutical, Inc. Announces Approval for Repaglinide Tablets, USP 4/29/2015
Pivotal Therapeutics Inc. Receives Health Canada Approval To Expand The Indication Of OMAZEN To Include Products With Claims To Maintain And Support Cardiovascular Health And Normal Triglyceride Levels 4/27/2015
Eli Lilly (LLY)'s CYRAMZA (ramucirumab) Receives Fourth FDA Approval 4/27/2015
Uni-Bio Files For China Approval Of Novel Osteoporosis Drug 4/24/2015
Celgene (CELG) Release: POMALYST (Pomalidomide) Label Update Including Progression-Free And Overall Survival Benefits Approved By FDA 4/24/2015
Medicure Inc. (MCU) Announces Approval Of Expanded Dosing Time For AGGRASTAT 4/23/2015
Mauna Kea Technologies Obtains Regulatory Approval For The Commercialization Of Cellvizio In Mexico 4/20/2015
Oasmia's Lead Cancer Product Paclical® Receives Market Approval In The Russian Federation 4/20/2015
The Medicines Company (MDCO) Release: FDA Approves New Formulation Of MINOCIN (Minocycline) For Injection 4/20/2015
Actavis (ACT) Announces FDA Approval Of Expanded Label For Botox (Onabotulinumtoxina) For The Treatment Of Upper Limb Spasticity In Adults 4/20/2015
Momenta (MNTA) Announces FDA Approval Of ANDA For Glatopa (Glatiramer Acetate Injection), The First Substitutable Generic For COPAXONE (Glatiramer Acetate Injection) 20mg 4/16/2015
Analysts Cheer As Amgen (AMGN) Nabs Long-Awaited FDA Approval of Heart Failure Drug Corlanor 4/16/2015
The Medicines Company (MDCO) Surges as FDA Panel Approves Once-Rejected Blood Clot Preventer 4/16/2015
China Biologic Products Receives Approval To Purchase Raw Materials 4/16/2015
Health Canada Approves New Indication For The Use Of Astellas Pharma Canada, Inc.'s Xtandi (enzalutamide) Capsules For Patients With Metastatic Castration-Resistant Prostate Cancer 4/16/2015
Momenta Pharmaceuticals, Inc. (MNTA) Announces Conference Call Details Regarding FDA Approval For Glatopa (Glatiramer Acetate Injection) 4/16/2015
FDA Advisory Committee Recommends Approval Of The Medicines Company (MDCO)'s Antiplatelet Therapy Cangrelor 4/16/2015
Relmada Therapeutics Receives Health Canada Clearance to Further Explore Promising NMDA Receptor Antagonist d-Methadone (REL-1017) 4/16/2015
Amgen (AMGN) Release: FDA Approves Corlanor (ivabradine) To Reduce The Risk Of Hospitalization For Worsening Heart Failure In Patients With Chronic Heart Failure 4/16/2015
FDA Approves Corlanor (ivabradine) To Reduce The Risk Of Hospitalization For Worsening Heart Failure In Patients With Chronic Heart Failure 4/15/2015
pSivida Corp (PSDV) Reports ILUVIEN For DME Approved In Poland 4/14/2015
Perrigo (PRGO) Announces FDA Approval And Upcoming Launch Of The AB Therapeutic Equivalent To Exalgo 4/8/2015
EU Approves Roche (RHHBY)’s Avastin Plus Chemotherapy For Women With Advanced Cervical Cancer 4/8/2015
Ferring Pharmaceuticals Announces European Approval Of New Room Temperature Stable Formulation Of PABAL (Carbetocin) 4/7/2015
Ariad (ARIA) Announces Approval Of Iclusig (As Ponatinib Hydrochloride) In Canada 4/6/2015
European Commission (EC) Approves Amgen (AMGN)'s Vectibix (panitumumab) As First-Line Treatment In Combination With FOLFIRI Chemotherapy For Metastatic Colorectal Cancer 4/6/2015
Antares Pharma, Inc. (ATRS) Announces FDA Approval Of TEV-TROPIN(R) 10 Mg (Human Growth Hormone) Needle-Free Injector 3/31/2015
Novartis Pharmaceutical Corporation (NVS) Announces FDA Approval For Jadenu To Simplify Treatment Administration For Patients With Chronic Iron Overload 3/31/2015
Janssen Research & Development Release: FDA Approves Label Update For ZYTIGA To Include Statistically Significant Overall Survival Results In Chemotherapy-Naive Men With Metastatic Castration-Resistant Prostate Cancer 3/30/2015
The Medicines Company (MDCO) Receives European Commission (EC) Approval For Three Hospital Acute Care Products: KENGREXAL (Cangrelor), ORBACTIV (Oritavancin) And RAPLIXA(Sealant Powder) 3/30/2015
NovoCure Ltd. Announces Japanese Approval Of Optune (The Novottf-100A System) For Treatment Of Recurrent Glioblastoma 3/30/2015
AstraZeneca PLC (AZN) Release: BRILINTA Receives FDA Approval For New Administration Option 3/30/2015
Genzyme (GENZ)’s Cerdelga (eliglustat) Capsules Approved In Japan 3/30/2015
Orexigen (OREX)'s Mysimba Approved In Europe For The Treatment Of Obesity 3/26/2015
Health Canada Greenlights IMRIS Ceiling-Mounted Intraoperative CT Solution 3/26/2015
Japan’s Ministry Of Health, Labour And Welfare Approves Gilead (GILD)’s Sovaldi (Sofosbuvir) For The Treatment Of Genotype 2 Chronic Hepatitis C 3/26/2015
Emergent BioSolutions (EBS) Receives FDA Approval Of Anthrasil, Its Anthrax Immune Globulin, For Use In The Treatment Of Inhalational Anthrax 3/25/2015
Sanofi Pasteur (SASY.PA) Announces FDA Approval Of Quadracel Dtap-IPV Vaccine For Children 4 Through 6 Years Of Age 3/25/2015
Regeneron (REGN) Release: EYLEA (aflibercept) Injection Receives FDA Approval For The Treatment Of Diabetic Retinopathy In Patients With Diabetic Macular Edema (DME) 3/25/2015
FDA Approves Genentech (RHHBY)'s Drug To Treat Children's Growth Disorder 3/24/2015
Ariad (ARIA) And Medison Pharma Ltd. Announce Approval Of Iclusig (Ponatinib) In Israel 3/24/2015
Asklepion Release: CHOLBAM (cholic acid) Now Approved In The U.S. For Patients With Bile Acid Synthesis Disorders 3/18/2015
Vertex (VRTX) Receives U.S. FDA Approval Of KALYDECO (Ivacaftor) For Children With Cystic Fibrosis Ages 2 To 5 Who Have Specific Mutations In The CFTR Gene 3/18/2015
Incyte Corporation (INCY) Release: Jakavi (ruxolitinib) Receives European Commission Approval As First Targeted Therapy For Patients With Polycythemia Vera 3/17/2015
Actavis (ACT) Receives FDA Approval For VIIBRYD (vilazodone HCl) 20mg Once Daily As A Therapeutic Dose 3/17/2015
ThromboGenics NV (TBGNF)'s JETREA Gains Approval In Brazil 3/16/2015
Actavis (ACT) Receives FDA Approval Of SAPHRIS For Pediatric Patients (Age 10-17) For Acute Treatment Of Manic Or Mixed Episodes Of Bipolar I Disorder 3/13/2015
Hetero Received Generic Sofosbuvir (Gilead (GILD)'s Sovaldi) Approval From Drug Controller General Of India (DCGI) 3/12/2015
United Therapeutics Corporation (UTHR) Release: FDA Approves Unituxin (dinutuximab) For The Treatment Of Pediatric High-Risk Neuroblastoma 3/10/2015
100 Pfizer (PFE) Scientists and Their Journey to Bring Ibrance to Market 3/10/2015
Novartis AG (NVS)'s Sandoz Bags Approval for First Biosimilar to be Sold in the U.S. 3/9/2015
Astellas Pharma Inc. (ALPMY) Receives FDA Approval for CRESEMBA (isavuconazonium sulfate) For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 3/9/2015
Endure Desensitizing Sexual Enhancement Spray Is FDA Approved 3/9/2015
Octapharma USA, Inc.: FDA Approves Octaplas License Supplement, Increasing Post Thaw Permitted Storage Time 3/9/2015
Basilea Pharmaceutica (BSLN.SW) Reports U.S. FDA Approval Of Isavuconazole For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 3/9/2015
Novartis AG (NVS) Release: FDA Approves First Biosimilar Zarxi (Filgrastim-Sndz) From Sandoz 3/6/2015
Bristol-Myers Squibb (BMY) Grabs Record Fast Approval for Opdivo 3/6/2015
Bioiberica Obtains Approval For Its Chondroitin Sulfate As An Ethical Drug In Osteoarthritis In Five More European Countries 3/5/2015
Pfizer (PFE) Receives European Approval For New Indication For Prevenar 13 For Prevention Of Vaccine-Type Pneumococcal Pneumonia In Adults 3/3/2015
Actavis (ACT) Hormonal Contraceptive Device Wins FDA Approval 3/2/2015
Actavis (ACT) Receives Approval From The European Commission For XYDALBA (dalbavancin) 3/2/2015
Sanofi (SAN.PA) Wins FDA Approval for New Insulin Drug Toujeo 2/27/2015
Otsuka Pharmaceutical Co., Ltd. Release: First-Ever Treatment Approved In Canada For Adults Living With ADPKD, A Life-Threatening Kidney Disease 2/27/2015
Actavis (ACT) And Medicines360 Announce FDA Approval Of LILETTA (Levonorgestrel-Releasing Intrauterine System) 52 Mg To Prevent Pregnancy For Up To Three Years 2/27/2015
Actavis (ACT) Receives U.S. FDA Approval For AVYCAZ (CEFTAZIDIME-AVIBACTAM) 2/26/2015
23andMe Wins FDA Approval for First Genetic Test Kit 2/26/2015
Sanofi (SAN.PA) Receives FDA Approval Of Once-Daily Basal Insulin Toujeo 2/26/2015
Zambon Release: Parkinson’s Disease (PD): EU Commission Approves Xadago (Safinamide) For Mid-Late Stage PD Patients 2/26/2015
Novartis AG (NVS)'s Farydak Wins FDA Approval After Setback 2/25/2015
Novartis AG (NVS) Receives FDA Approval Of Farydak, The First HDAC Inhibitor For Patients With Multiple Myeloma 2/24/2015
MEDA: Dymista Approved In Children 6 To 11 Years Of Age With Seasonal Allergic Rhinitis 2/23/2015
Celgene International Sárl (CELG) Release: REVLIMID (Lenalidomide) Approved By European Commission (EC) For The Treatment Of Adult Patients With Previously Untreated Multiple Myeloma Who Are Not Eligible For Transplant 2/23/2015
Actavis (ACT) Receives Final Approval For Generic Version Of Subutex 2/20/2015
Celgene (CELG) Release: REVLIMID (Lenalidomide) Approved By The European Commission For The Treatment Of Adult Patients With Previously Untreated Multiple Myeloma Who Are Not Eligible For Transplant 2/20/2015
23andMe Granted Authorization By FDA To Market First Direct-To-Consumer Genetic Test Under Regulatory Pathway For Novel Devices 2/20/2015
Celgene (CELG) Release: FDA Expands Indication For REVLIMID® (Lenalidomide) In Combination With Dexamethasone To Include Patients Newly Diagnosed With Multiple Myeloma 2/18/2015
FDA Approves Eisai Company (ESALY.PK)'s LENVIMA (Lenvatinib) For The Treatment Of Patients With Locally Recurrent Or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer 2/16/2015
Teijin Limited Release: Small-sized MUCOSOLVAN L Expectorant Tablet 45 Mg Approved In Japan 2/16/2015
Eisai Company, Ltd. (ESALY.PK)'s Thyroid Drug Snags Early FDA Approval 2/13/2015
MerLion Pharmaceuticals Pte Ltd Announces FDA Approval Of Finafloxacin Otic Suspension 2/11/2015
Genentech (RHHBY)'s Lucentis Is the First Drug to Win Approval for Diabetic Retinopathy 2/10/2015
FDA Approves Genentech (RHHBY)’s Lucentis (Ranibizumab Injection) For Treatment Of Diabetic Retinopathy In People With Diabetic Macular Edema 2/9/2015
FDA Green Lights Pfizer (PFE)'s High Profile Breast Cancer Drug Two Months Early 2/5/2015
CrystalGenomics Receives MFDS Approval For Acelex® (Polmacoxib) 2/5/2015
Pfizer (PFE) Release: FDA Approves Ibrance For Postmenopausal Women With Advanced Breast Cancer 2/3/2015
The Obesity Society: FDA Approves New Drug For Binge Eating Disorder (BED) 2/3/2015
BioSpecifics Technologies Corporation (BSTC) Announces Approval Of XIAPEX® In The EU For The Treatment Of Peyronie's Disease 2/2/2015
FDA Approves New Dosing Option for CSL Behring's Hizentra® 2/2/2015



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