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Clinical - Approvals
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
Nova Laboratories Release: FDA Approves First Aseptically Spray Dried Biologic 5/14/2015
LabStyle Innovations Receives Health Canada Approval For Commercialization Of The Dario Diabetes Management Solution 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
Bayer AG (BAYZF) Adds Two Indications In China For Anticoagulant Xarelto 5/5/2015
GlaxoSmithKline (GSK) Slips as FDA Approves Asthma Drug for Adults, Not Younger Patients 5/5/2015
Kythera (KYTH) Grabs FDA Approval for Chin Fat-Busting Drug 5/4/2015
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
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
GlaxoSmithKline (GSK) Release: FDA Approves BREO ELLIPTA For The Treatment Of Adults With Asthma In The US 5/1/2015
Vernalis PLC (VNLPY.PK) And Tris Pharma, Inc. Receive FDA Approval Of NDA For Tuzistra XR (Codeine Polistirex And Chlorpheniramine Polistirex) 5/1/2015
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
Eli Lilly (LLY)'s CYRAMZA (ramucirumab) Receives Fourth FDA Approval 4/27/2015
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
Celgene (CELG) Release: POMALYST (Pomalidomide) Label Update Including Progression-Free And Overall Survival Benefits Approved By FDA 4/24/2015
Uni-Bio Files For China Approval Of Novel Osteoporosis Drug 4/24/2015
Medicure Inc. (MCU) Announces Approval Of Expanded Dosing Time For AGGRASTAT 4/23/2015
Actavis (ACT) Announces FDA Approval Of Expanded Label For Botox (Onabotulinumtoxina) For The Treatment Of Upper Limb Spasticity In Adults 4/20/2015
The Medicines Company (MDCO) Release: FDA Approves New Formulation Of MINOCIN (Minocycline) For Injection 4/20/2015
Oasmia's Lead Cancer Product Paclical® Receives Market Approval In The Russian Federation 4/20/2015
Mauna Kea Technologies Obtains Regulatory Approval For The Commercialization Of Cellvizio In Mexico 4/20/2015
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
Relmada Therapeutics Receives Health Canada Clearance to Further Explore Promising NMDA Receptor Antagonist d-Methadone (REL-1017) 4/16/2015
FDA Advisory Committee Recommends Approval Of The Medicines Company (MDCO)'s Antiplatelet Therapy Cangrelor 4/16/2015
Momenta Pharmaceuticals, Inc. (MNTA) Announces Conference Call Details Regarding FDA Approval For Glatopa (Glatiramer Acetate Injection) 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
China Biologic Products Receives Approval To Purchase Raw Materials 4/16/2015
The Medicines Company (MDCO) Surges as FDA Panel Approves Once-Rejected Blood Clot Preventer 4/16/2015
Momenta Pharmaceuticals, Inc. (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
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
EU Approves Roche (RHHBY)’s Avastin Plus Chemotherapy For Women With Advanced Cervical Cancer 4/8/2015
Perrigo (PRGO) Announces FDA Approval And Upcoming Launch Of The AB Therapeutic Equivalent To Exalgo 4/8/2015
Ferring Pharmaceuticals Announces European Approval Of New Room Temperature Stable Formulation Of PABAL (Carbetocin) 4/7/2015
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
Ariad (ARIA) Announces Approval Of Iclusig (As Ponatinib Hydrochloride) In Canada 4/6/2015
Novartis Pharmaceutical Corporation (NVS) Announces FDA Approval For Jadenu To Simplify Treatment Administration For Patients With Chronic Iron Overload 3/31/2015
Antares Pharma, Inc. (ATRS) Announces FDA Approval Of TEV-TROPIN(R) 10 Mg (Human Growth Hormone) Needle-Free Injector 3/31/2015
Genzyme (GENZ)’s Cerdelga (eliglustat) Capsules Approved In Japan 3/30/2015
AstraZeneca PLC (AZN) Release: BRILINTA Receives FDA Approval For New Administration Option 3/30/2015
NovoCure Ltd. Announces Japanese Approval Of Optune (The Novottf-100A System) For Treatment Of Recurrent Glioblastoma 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
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
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
Health Canada Greenlights IMRIS Ceiling-Mounted Intraoperative CT Solution 3/26/2015
Orexigen (OREX)'s Mysimba Approved In Europe For The Treatment Of Obesity 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
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
Sanofi Pasteur (SASY.PA) Announces FDA Approval Of Quadracel Dtap-IPV Vaccine For Children 4 Through 6 Years Of Age 3/25/2015
Ariad (ARIA) And Medison Pharma Ltd. Announce Approval Of Iclusig (Ponatinib) In Israel 3/24/2015
FDA Approves Genentech (RHHBY)'s Drug To Treat Children's Growth Disorder 3/24/2015
Asklepion Pharmaceuticals, LLC. 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
Actavis (ACT) Receives FDA Approval For VIIBRYD (vilazodone HCl) 20mg Once Daily As A Therapeutic Dose 3/17/2015
Incyte Corporation (INCY) Release: Jakavi (ruxolitinib) Receives European Commission Approval As First Targeted Therapy For Patients With Polycythemia Vera 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
100 Pfizer (PFE) Scientists and Their Journey to Bring Ibrance to Market 3/10/2015
United Therapeutics Corporation (UTHR) Release: FDA Approves Unituxin (dinutuximab) For The Treatment Of Pediatric High-Risk Neuroblastoma 3/10/2015
Astellas Pharma Inc. (ALPMY) Receives FDA Approval for CRESEMBA (isavuconazonium sulfate) For The Treatment Of Invasive Aspergillosis And Invasive Mucormycosis 3/9/2015
Novartis AG (NVS)'s Sandoz Bags Approval for First Biosimilar to be Sold in the U.S. 3/9/2015
Endure Desensitizing Sexual Enhancement Spray Is FDA Approved 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
Octapharma USA, Inc.: FDA Approves Octaplas License Supplement, Increasing Post Thaw Permitted Storage Time 3/9/2015
Bristol-Myers Squibb (BMY) Grabs Record Fast Approval for Opdivo 3/6/2015
Novartis AG (NVS) Release: FDA Approves First Biosimilar Zarxi (Filgrastim-Sndz) From Sandoz 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
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
Otsuka Pharmaceutical Co., Ltd. Release: First-Ever Treatment Approved In Canada For Adults Living With ADPKD, A Life-Threatening Kidney Disease 2/27/2015
Zambon Release: Parkinson’s Disease (PD): EU Commission Approves Xadago (Safinamide) For Mid-Late Stage PD Patients 2/26/2015
Sanofi (SAN.PA) Receives FDA Approval Of Once-Daily Basal Insulin Toujeo 2/26/2015
23andMe Wins FDA Approval for First Genetic Test Kit 2/26/2015
Actavis (ACT) Receives U.S. FDA Approval For AVYCAZ (CEFTAZIDIME-AVIBACTAM) 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
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
MEDA: Dymista Approved In Children 6 To 11 Years Of Age With Seasonal Allergic Rhinitis 2/23/2015
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: 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
Actavis (ACT) Receives Final Approval For Generic Version Of Subutex 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
Teijin Limited Release: Small-sized MUCOSOLVAN L Expectorant Tablet 45 Mg Approved In Japan 2/16/2015
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
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
CrystalGenomics Receives MFDS Approval For Acelex® (Polmacoxib) 2/5/2015
FDA Green Lights Pfizer (PFE)'s High Profile Breast Cancer Drug Two Months Early 2/5/2015
The Obesity Society: FDA Approves New Drug For Binge Eating Disorder (BED) 2/3/2015
Pfizer (PFE) Release: FDA Approves Ibrance For Postmenopausal Women With Advanced Breast Cancer 2/3/2015
BioSpecifics Technologies Corporation (BSTC) Announces Approval Of XIAPEX® In The EU For The Treatment Of Peyronie's Disease 2/2/2015
Shire (SHPGY) Release: Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) Becomes First And Only Treatment Approved By The FDA For Adults With Moderate To Severe Binge Eating Disorder 2/2/2015
Zogenix, Inc. (ZGNX) Receives FDA Approval Of New Formulation Of Zohydro® ER 2/2/2015
FDA Approves New Dosing Option for CSL Behring's Hizentra® 2/2/2015
Swedish Orphan Biovitrum Release: Xiapex Approved By The EU Commission For The Treatment Of Peyronie's Disease 1/30/2015
FDA Green Lights Bristol-Myers Squibb Company (BMY), Johnson & Johnson (JNJ) HIV Pills 1/30/2015
FDA Approves Bristol-Myers Squibb Company (BMY)’s Evotaz™ (Atazanavir And Cobicistat) For The Treatment Of HIV-1 Infection In Adults 1/30/2015
Janssen Therapeutics Release: PREZCOBIX™ (Darunavir/Cobicistat) Approved In The U.S. For The Treatment Of Adults Living With HIV-1 1/30/2015
Janssen Biotech Inc. (JNJ) Release: U.S. FDA Approves IMBRUVICA® (ibrutinib) For The Treatment Of Waldenstrom's Macroglobulinemia: First FDA-Approved Therapy For This Disease 1/29/2015
FDA Backs Teva Pharmaceutical Industries Limited (TEVA)'s Generic Nexium in Blow to AstraZeneca PLC (AZN), Ranbaxy Laboratories (RANBAXY.BO) 1/27/2015
Shire (SHPGY)'s $5.2 Billion Bet Pays Off as NPS Pharmaceuticals, Inc. (NPSP)'s Natpara Wins Approval 1/27/2015
FDA Says Yes to Rockwell Medical (RMTI)'s Iron Replacement Drug 1/27/2015
Novo Nordisk A/S (NVO) Receives FDA Approval For Norditropin® Flexpro® 30 Mg/3.0 Ml For Patients With Growth Hormone Disorders 1/27/2015
Moberg Pharma AB (Formerly known as Moberg Derma)'s Fungal Nail Product Approved In China 1/27/2015
Symplmed Announces FDA Approval of Prestalia® for Treatment of Hypertension 1/26/2015
NPS Pharmaceuticals, Inc. (NPSP) Release: FDA Approves Natpara® (Parathyroid Hormone) For Injection As An Adjunct To Calcium And Vitamin D To Control Hypocalcemia In Patients With Hypoparathyroidism 1/26/2015
Novartis AG (NVS) Bexsero® Vaccine Approved By FDA For The Prevention Of Meningitis B, The Leading Cause Of Bacterial Meningitis In The US 1/26/2015
Shire Comments On Press Release From FDA Regarding NPS Pharmaceuticals, Inc. (NPSP) Approval Of NATPARA® (Parathyroid Hormone) 1/26/2015
The National Meningitis Association (NMA) Applauds FDA Approval Of Second Vaccine To Protect Against Serogroup B Meningococcal Disease 1/26/2015
FDA Approves Rockwell Medical (RMTI)l's Triferic™ For Iron Replacement And Maintenance Of Hemoglobin In Hemodialysis Patient 1/26/2015
Incyte Corporation (INCY) Earns $25 Million Milestone As Jakavi® (ruxolitinib) Recommended For Approval In Europe For Polycythemia Vera 1/23/2015
f-Star Approves Novartis AG (NVS)'s Cosentyx for Painful Skin Disease 1/23/2015
Novartis AG (NVS) Announces FDA Approval For First IL-17A Antagonist Cosentyx™ (Secukinumab) For Moderate-To-Severe Plaque Psoriasis Patients 1/22/2015
Marrone Bio Innovations, Inc' REGALIA® MAXX Biofungicide Approved For New Uses In Canada 1/22/2015
Akorn, Inc. (AKN) Receives FDA Approval For Phenylephrine HCl Ophthalmic Solution 1/20/2015
Baxter International, Inc. (BAX) Receives FDA Approval For PHOXILLUM Solution For Electrolyte Management During Continuous Renal Replacement Therapy 1/20/2015
China Approves World's First Inactive Sabin Strain Polio Vaccine 1/20/2015
Fresenius Kabi AG Receives FDA Approval For Neostigmine Methylsulfate Injection 1/19/2015
Boehringer Ingelheim Corporation Release: OFEV® (Nintedanib*) Approved In The EU For The Treatment Of IPF 1/19/2015
AbbVie (ABBV) Announces U.S. FDA Approval Of DUOPA™ (carbidopa and levodopa) Enteral Suspension For The Treatment Of Motor Fluctuations In Patients With Advanced Parkinson's Disease 1/16/2015
CeloNova BioSciences Receives Expanded Indication For Benign Prostatic Hyperplasia (BPH) 1/14/2015
AbbVie (ABBV) Announces U.S. FDA Approval Of DUOPA™ (carbidopa and levodopa) Enteral Suspension For The Treatment Of Motor Fluctuations In Patients With Advanced Parkinson's Disease 1/12/2015
HUYA Bioscience International Announces Regulatory Approval Of Chidamide, The First Selective HDAC Inhibitor In China 1/12/2015
U.S. FDA Approves Daiichi Sankyo, Inc. (4568.t)'s Once-Daily SAVAYSA™ (Edoxaban) Tablets For Reduction Of Stroke Risk In Non-Valvular Atrial Fibrillation And For The Treatment Of Venous Thromboembolism 1/9/2015
FDA Green Lights Daiichi Sankyo (DSNKY)'s New Anti-Clotting Drug 1/9/2015
Impax Pharmaceuticals (IPXL) Announce FDA Approval Of RYTARY™ (Carbidopa And Levodopa) Extended-Release Capsules For The Treatment Of Parkinson's Disease 1/8/2015
Lyophilization Services of New England Receives Approval To Manufacture Commercial Aseptic Product 1/7/2015
Suneva Medical Release: Bellafill® Receives FDA Approval For Treatment Of Acne Scars 1/6/2015
Actavis (ACT), Adamas Pharmaceuticals (ADMS) Win FDA Approval for Alzheimer's Drug Namzaric 1/5/2015
Vertex Pharmaceuticals (MA) (VRTX) Release: FDA Approves KALYDECO® (Ivacaftor) For Use In People With Cystic Fibrosis Ages 6 And Older Who Have The R117H Mutation 12/30/2014
FDA Denies Approval for Actavis (ACT)' Hypertension Combo Treatment 12/30/2014
Hospira, Inc. Receives U.S. FDA Approval Of Proprietary Analgesic Dyloject™(diclofenac sodium) Injection 12/30/2014
FDA Approves Novo Nordisk A/S (NVO)'s Weight Management Drug Saxenda 12/29/2014
Actavis (ACT) Confirms Complete Response Letter For Nebivolol/Valsartan Fixed-Dose Combination For Hypertension 12/29/2014
BioMarin Pharmaceutical Inc. (BMRN) Announces Approval Of VIMIZIM® (Elosulfase Alfa) In Japan For Treatment Of Morquio A Syndrome 12/29/2014
Novo Nordisk A/S (NVO) Receives FDA Approval For Saxenda® For The Treatment Of Obesity 12/24/2014
AstraZeneca PLC (AZN) Grabs Accelerated FDA Approval for Lynparza 12/24/2014
FDA Grants Accelerated Approval for Bristol-Myers Squibb Company (BMY)'s Skin Cancer Drug Opdivo 12/24/2014
Actavis (ACT) and Adamas Pharmaceuticals (ADMS) Announce FDA Approval of Namzaric™, a Fixed-Dose Combination of Memantine Extended-Release and Donepezil Hydrochloride 12/24/2014
FDA Approves Teva Pharmaceutical Industries Limited (TEVA)’s GRANIX® (Tbo-Filgrastim) Injection For Self-Administration 12/23/2014
Galderma Laboratories Receives FDA Approval Of Novel Treatment Option For Rosacea Patients 12/23/2014
Bristol-Myers Squibb Company (BMY) Receives Accelerated Approval Of Opdivo (Nivolumab) From The FDA 12/23/2014
AbbVie (ABBV) Receives Health Canada Approval Of HOLKIRA™ PAK For The Treatment Of Chronic Genotype 1 Hepatitis C 12/23/2014
FDA Approves Biocryst Pharmaceuticals (BCRX)'s Intravenous Flu Drug Rapivab 12/22/2014
FDA Approves AbbVie (ABBV)'s All-Oral Hepatitis C Drug Viekira Pak 12/22/2014
AbbVie (ABBV) Receives U.S. FDA Approval Of VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) For The Treatment Of Chronic Genotype 1 Hepatitis C 12/22/2014
Biocryst Pharmaceuticals (BCRX)'s RAPIVAB™ (Peramivir Injection) Receives FDA Approval For The Treatment Of Acute Uncomplicated Influenza 12/22/2014
Jazz Pharmaceuticals (JAZZ) Receives FDA Approval For Intravenous Administration Of Erwinaze® (Asparaginase Erwinia Chrysanthemi) 12/22/2014
AstraZeneca PLC (AZN) Release: LYNPARZA™ Approved By The FDA For The Treatment Of Advanced Ovarian Cancer In Patients With Germline BRCA-Mutations 12/22/2014
LYNPARZA™ (Olaparib) Approved For The Treatment Of Advanced Relapsed Ovarian Cancer In Patients With Germline BRCA Mutations, Available Exclusively At Biologics, Inc. (NC) 12/22/2014
Cubist Pharmaceuticals, Inc. (CBST) Announces FDA Approval Of New Antibiotic ZERBAXA™ (Ceftolozane/Tazobactam) For Complicated Urinary Tract And Complicated Intra-abdominal Infections 12/22/2014
Enanta Pharmaceuticals, Inc. Announces FDA Approves AbbVie (ABBV)’s VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) For The Treatment Of Chronic Genotype 1 Hepatitis C Virus 12/22/2014
Alcon Laboratories, Inc. (ACL) Release: FDA Approves Xtoro To Treat Swimmer's Ear 12/19/2014
Teva Pharmaceutical Industries Limited (TEVA) Announces FDA Approval Of QNASL® (Beclomethasone Dipropionate) Nasal Aerosol For Treatment Of Children With Seasonal And Perennial Allergic Rhinitis 12/19/2014
Eli Lilly (LLY)'s CYRAMZA (ramucirumab) Receives Third FDA Approval 12/18/2014
FDA Approves Novartis AG (NVS) Drug For Rare Hormonal Disorder 12/17/2014
Allaccem, Inc. Receives Formulary Approval For SANOS® From The Veterinary Medical Standardization Board Of The US Army Public Health Command 12/17/2014
Ipsen (IPN.PA) Announces FDA Approval Of Somatuline® Depot® (Lanreotide) Injection For The Treatment Of Gastroenteropancreatic Neuroendocrine Tumors 12/17/2014
Novartis AG (NVS) Gains FDA Approval For Signifor® LAR To Treat Patients With Acromegaly, A Rare And Life-Threatening Hormonal Disorder 12/16/2014
Sanofi Pasteur (SASY.PA) Announces FDA Approval Of Fluzone Intradermal Quadrivalent (Influenza Vaccine) For Adults 12/12/2014
Orexo AB (ORXOF): FDA Approves Two Higher Dosage Strengths Of ZUBSOLV® 12/12/2014
FDA Approves Merck & Co. (MRK)'s HPV Vaccine, GARDASIL®9, To Prevent Cancers And Other Diseases Caused By Nine HPV Types – Including Types That Cause About 90% Of Cervical Cancer Cases 12/12/2014
BioMarin Pharmaceutical Inc. (BMRN)'s VIMIZIM® (Elosulfase Alfa) Approved In Brazil For Treatment Of Morquio A Syndrome 12/10/2014
Iroko Pharmaceuticals Announces International Regulatory Approval For ZORVOLEX® 12/10/2014
Nektar Therapeutics (CA) (NKTR) Release: MOVENTIG Approved In The European Union For Opioid-Induced Constipation 12/9/2014
Amgen (AMGN) Wins FDA Approval For New XGEVA Indication 12/9/2014
FDA Approves Amgen (AMGN)'s XGEVA (Denosumab) For The Treatment Of Hypercalcemia Of Malignancy Refractory To Bisphosphonate Therapy 12/8/2014
BioMarin Pharmaceutical Inc. (BMRN)''s VIMIZIM® (Elosulfase Alfa) Approved In Australia For Treatment Of Morquio A Syndrome 12/8/2014
Merz Dermatology Announces Approval Of Naftin (Naftifine HCL) Gel And Cream 2% For Use With Pediatric Patients 12/8/2014
WraSer Pharmaceuticals, LLC Receives FDA Approval On Trezix Capsules, CIII For Moderate To Moderately Severe Pain 12/5/2014
FDA Approves Incyte Corporation (INCY)'s Jakafi For Patients With Polycythemia Vera 12/5/2014
Speedy FDA Approval For Amgen (AMGN)'s Leukemia Immunotherapy BLINCYTO 12/5/2014
National Institute for Clinical Excellence (NICE) Reverses October Decision And Approves Roche (RHHBY)'s Oncology Drug Gazyvaro 12/3/2014
Astellas Pharma US Release: XTANDI™ (Enzalutamide) Now Approved In Europe For The Treatment Of Men With Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve 12/2/2014
pSivida Corp (PSDV) Reports ILUVIEN® Granted Marketing Authorization In The Netherlands 12/2/2014
Perrigo Company (PRGO) Announces FDA Approval And Launch Of The Generic Version Of Pennsaid 1.5% W/W 12/2/2014
Sanofi (SAN.PA) Gets U.S. Approval For Use Of Priftin Drug In Latent TB 12/2/2014
Bayer Receives Health Canada Approval for Eylea For Two Additional Indications 12/1/2014
Once-Weekly Eli Lilly (LLY) Diabetes Drug Wins FDA Approval 11/26/2014
FDA Approves Valeant (VRX)'s Onexton Gel For Acne Treatment 11/26/2014
Bristol-Myers Squibb Company (BMY) Release: ELIQUIS Approved For Treatment Of Venous thromboembolic events (Deep Vein Thrombosis [DVT], Pulmonary Embolism [PE]) and prevention of recurrent DVT and PE 11/26/2014
European Commission (EC) Approves Janssen-Cilag International NV (JNJ)'s Rezolsta 11/25/2014
Ariad Pharmaceuticals, Inc. (ARIA) And Specialised Therapeutics Australia Announce Approval Of Iclusig (Ponatinib) In Australia 11/24/2014
Purdue Pharma L.P. Wins FDA Approval For Powerful Painkiller Hysingla 11/24/2014
Health Canada Approves IMBRUVICA By Priority Review, Giving Physicians And Patients A Much-Needed Option In The Fight Against Chronic Lymphocytic Leukemia 11/19/2014
Celgene (CELG) Announces Swissmedic Approval Of REVLIMID® (Lenalidomide) For Treatment Of Patients With Relapsed Or Refractory 11/18/2014
Regeneron (REGN) Announces EYLEA (aflibercept) Injection Approved For The Treatment Of Diabetic Macular Edema (DME) In Japan 11/18/2014
Regeneron (REGN)'s Eylea Gets Japanese Nod For Macular Edema 11/18/2014
(Pr)OTEZLA® (apremilast tablets), First In A New Class Of Oral Treatment, Receives Health Canada Approval For Plaque Psoriasis 11/18/2014