News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter

Clinical - Approvals (World)
Debiopharm's Partner Yakult Honsha Announces Elplat Approbation In Gastric Cancer In Japan 11/24/2015
Swedish Orphan Biovitrum And Biogen (BIIB)’s ELOCTA (rFVIIIFc) Approved In Europe For The Treatment Of Haemophilia A 11/24/2015
FDA Grants Full U.S. Approval for Novartis AG (NVS)' Targeted Skin Cancer Combo 11/23/2015
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
Acerus Reports Approval Of ESTRACE Generic In Canada 11/20/2015
Samsung Bioepis, Biogen (BIIB) Biosimilar is About to Take a Huge Chunk of Pfizer (PFE)'s Profits 11/20/2015
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
Genmab A/S (GEN.CO) Announces U.S. FDA Approval Of DARZALEX (Daratumumab) For Multiple Myeloma And Updates Financial Guidance 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
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
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Announce First European Marketing Approval Of RIZAPORT (RHB-103) For Migraines 11/9/2015
FDA Green Lights GlaxoSmithKline (GSK)'s Nucala for Severe Asthma 11/5/2015
Implanet Release: ANVISA Regulatory Approval Granted In Brazil To Market The JAZZ Band Platform 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
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
AV Medical Tech Snags FDA Approval for its Chameleon Angioplasty Balloon Catheter 10/27/2015
Sinovac Biotech Ltd. (SVA) Receives Clinical Trial Approval For Varicella Vaccine Candidate 10/26/2015
PharmaEngine, Inc. Announces Taiwan FDA Approval of ONIVYDE (irinotecan liposome injection) For The Treatment Of Metastatic Pancreatic Cancer 10/22/2015
Bio Products Laboratory Receives FDA Approval For Coagadex (Coagulation Factor X, Human) 10/21/2015
Argentina's Ministry Of Health Approves MediWound (MDWD)'s NexoBrid 10/20/2015
FDA Green Lights Boehringer Ingelheim's Blood Thinner Reversal Agent Praxbind 10/19/2015
Swedish Orphan Biovitrum Release: Xiapex Approved For The Treatment Of Peyronie's Disease In Switzerland 10/16/2015
APR Applied Pharma Research S.A. (APR) Announces The European Class III CE Mark Approval Of Nexodyn Acidoxidizing Solution (AOS) For The Management Of Acute And Chronic Wounds 10/14/2015
PharmaRoth Labs Announces Approval Of Sucanon In Canada 10/14/2015
Safe Orthopaedics Obtains FDA Approval To Market Its Unique Implant For Spinal Trauma Care In The United States 10/13/2015
Teva (TEVA) Announces Approval Of Three-Times-A-Week COPAXONE 40 Mg/Ml In Russia For The Treatment Of Relapsing-Remitting Multiple Sclerosis 10/8/2015
Avita Medical Snags CE Mark for ReGenerCell and ReNovaCell to Complete Skin Healing Portfolio 10/7/2015
FDA Green Lights Alkermes (ALKS)' Schizophrenia Treatment Aristada 10/7/2015
InspireMD Ltd. Announces CGuard Approval In Columbia 10/5/2015
Allergan (AGN) Release: U.S. FDA Approves JUVEDERM ULTRA XC For Use In Lips 10/1/2015
SpineGuard Receives CE Mark For New Application Of Its Disruptive DSG (Dynamic Surgical Guidance) Platform 9/30/2015
As Spinoff Rumors Spin, Sanofi (SNY)’s Cholesterol Drug Praluent Gets Approval in Europe 9/29/2015
AbbVie (ABBV)'s VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) Receives Approval In Japan For The Treatment Of Genotype 1 Chronic Hepatitis C 9/28/2015
Merck & Co. (MRK)'s Once-Weekly Diabetes drug MARIZEV Approved in Japan 9/28/2015
Enanta Pharmaceuticals, Inc. Announces Approval Of VIEKIRAX (Ombitasvir/Paritaprevir/Ritonavir Tablets) In Japan For The Treatment Of Genotype 1 Chronic Hepatitis C 9/28/2015
Teva (TEVA) Announces Approval Of COPAXONE In Japan For The Prevention Of Relapse Of Multiple Sclerosis 9/28/2015
Takeda Pharmaceutical Co. Ltd. (TKPYY): New Drug Application Approval In Japan For Copaxone Subcutaneous Injection 20 Mg Syringe, A Drug For The Treatment Of Multiple Sclerosis 9/28/2015
Keryx (KERX) Receives European Approval For Fexeric (Ferric Citrate Coordination Complex) For The Treatment Of Hyperphosphatemia In Adults With Chronic Kidney Disease 9/24/2015
Medical Developments International Limited Release: Green Whistle Receives Regulatory Approval In Singapore 9/24/2015
Starpharma Release: EU Marketing Approval Granted For VivaGel BV 9/24/2015
Implanet: New JAZZ Band FDA Clearance Expands Posterior Fixation System Selection 9/23/2015
VolitionRX Wins First CE Mark for NuQ Blood Assay for Colorectal Cancer Detection 9/22/2015
Shire (SHPG) Receives European Approval For INTUNIV (Guanfacine) Hydrochloride Prolonged Release Tablets) As A Non-Stimulant ADHD Treatment For Children And Adolescents 9/21/2015
Eli Lilly (LLY) Release: New Gastric Cancer Medicine Approved And Available For Use In Canada 9/21/2015
Specialised Therapeutics Australia' Breakthrough Brain Tumour Visualisation Drug GLIOLAN Approved For Use In New Zealand 9/18/2015
Full Product Approval In Japan Received By Mesoblast (MSB.AX) Licensee 9/18/2015
FDA Approves Allergan (AGN) and Gedeon Richter (RIG2.F)'s Antipsychotic Vraylar 9/18/2015
Health Canada Approves Amgen (AMGN)'s New Cholesterol-Lowering Medication Repatha (evolocumab) 9/15/2015
Allergan (AGN) And Perrigo (PRGO) Receive FDA Approval Of Three Extended Release Products Equivalent To Mucinex And Mucinex DM 9/11/2015
BioLineRx Ltd.’s Novel Treatment For Non-Surgical Removal Of Skin Lesions Submitted For CE Mark Registration 9/9/2015
Thermo Fisher Scientific (TMO) Receives IVDD CE Mark for its Thermo Scientific Prelude MD HPLC, Endura MD Mass Spectrometer and ClinQuan MD Software 9/8/2015
Merck & Co. (MRK) And Samsung Bioepis Announce Approval Of BRENZYS (Etanercept), A Biosimilar Of Enbrel, In Korea 9/8/2015
AstraZeneca PLC (AZN) Wins FDA Green Light for Long-Term Brilinta Use in U.S. 9/4/2015
Salutaris Medical Devices Announces 510(k) Clearance 9/3/2015
Allergan (AGN) Announces FDA Approval Of Updated Label For TEFLARO (ceftaroline fosamil) 9/2/2015
Alexion (ALXN) Release: European Commission Grants Marketing Authorization For Strensiq (Asfotase Alfa) For The Treatment Of Patients With Pediatric-Onset Hypophosphatasia (HPP) 9/1/2015
Alexion (ALXN) Release: European Commission Grants Marketing Authorization For Kanuma (Sebelipase Alfa) For The Treatment Of Patients Of All Ages With Lysosomal Acid Lipase Deficiency (LAL-D) 9/1/2015
MagVenture's Major Depressive Disorder Therapy System Wins FDA Approval 8/28/2015
Exelixis (EXEL) Announces First Regulatory Approval Of Cobimetinib In Switzerland 8/27/2015
Swedish Orphan Biovitrum Release: Kineret Receives Australian Regulatory Approval For Use In Systemic Juvenile Idiopathic Arthritis 8/19/2015
Alexion Pharma Canada Release: Health Canada Approves Strensiq (asfotase alfa), The First Therapy For Patients With Hypophosphatasia (HPP), An Ultra-Rare, Life-Threatening Disease 8/17/2015
Biogen Canada Inc. Release: Health Canada Approves PLEGRIDY (peginterferon beta-1a) For Adults With Relapsing Remitting Multiple Sclerosis 8/13/2015
Orexo AB (ORXOF) Wins FDA Approval for ZUBSOLV 8/11/2015
Health Canada Approves he Glaukos iStent inject 8/10/2015
GlaxoSmithKline (GSK) Receives Approval For BREO ELLIPTA For The Treatment Of Adults With Asthma 8/7/2015
BTG plc (BTG.L) Release: Health Canada Approves Varithena (Polidocanol Injectable Foam) For Patients With Varicose Veins 8/6/2015
Sorin Group S.p.A. (SRN) Obtains Health Canada Approval for Perceval, Its Next Generation Sutureless Valve 8/5/2015
EMBA Medical Limited Awarded CE Certificate For Hourglass Peripheral Embolization Plug 7/29/2015
Juniper Pharmaceuticals Announces Regulatory Approvals For CRINONE Progesterone Gel In Nine New EU Countries 7/28/2015
FDA Approves Cholesterol Drug Praluent From Regeneron (REGN), Sanofi (SNY) 7/24/2015
Theravance (THRX) Announces Health Canada Approval For VIBATIV (telavancin) for Treatment of HAP/VAP Caused By Gram-Positive Bacteria, Including MRSA 7/23/2015
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
Galderma Canada Release: Novel Rosacea Treatment Approved By Health Canada For Adult Patients 7/20/2015
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
FDA Green Lights AstraZeneca PLC (AZN)'s Lung Cancer Drug Iressa 7/14/2015
Veloxis Pharmaceuticals A/S (VELO) Announces U.S. FDA Approval of Envarsus XR For Treatment Of Kidney Transplant Patients 7/13/2015
Otsuka Pharma, H. Lundbeck A/S (LUN.CO) Beat Competitors With FDA Approval of Schizophrenia Drug 7/13/2015
Novartis AG (NVS) Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20% 7/9/2015
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
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
Alexion (ALXN) Release: Strensiq (asfotase alfa) Receives Marketing Approval In Japan For Treatment Of Patients With Hypophosphatasia (HPP) 7/6/2015
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
Boehringer Ingelheim Release: New Advance In COPD Maintenance Treatment, Spiolto Respimat, Approved In First European Countries 7/2/2015
SpineGuard Obtains Regulatory Clearance To Sell Pediguard In The World’s Second-Largest Spine Market: China 6/30/2015
New Indication For Teijin Pharma’s Febuxostat In Europe 6/30/2015
Swedish Orphan Biovitrum Release: European Commission (EC) Approves Orfadin Oral Suspension 6/29/2015
Regeneron (REGN) Release: EYLEA (aflibercept) Injection Receives Approval In Japan For The Treatment Of Retinal Vein Occlusion 6/26/2015
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
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
Hospira Release: ANVISA Approves First Infliximab Biosimilar In Brazil 6/2/2015
Salix (SLXP) Announces FDA Approval of Xifaxan 550 mg For The Treatment Of IBS-D (Irritable Bowel Syndrome With Diarrhea) 5/28/2015
Boehringer Ingelheim Release: Type 2 Diabetes: Synjardy (Empagliflozin/Metformin Hydrochloride) Approved In The European Union 5/28/2015
MYOS (MYOS) Receives Health Canada Approval Of Proprietary Ingredient Fortetropin 5/28/2015
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
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
Boehringer Ingelheim Grabs FDA Approval for Next-Gen COPD Drug 5/26/2015
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
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
Uni-Bio Files For China Approval Of Novel Osteoporosis Drug 4/24/2015
Actavis (ACT) Announces FDA Approval Of Expanded Label For Botox (Onabotulinumtoxina) For The Treatment Of Upper Limb Spasticity In Adults 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
Relmada Therapeutics Receives Health Canada Clearance to Further Explore Promising NMDA Receptor Antagonist d-Methadone (REL-1017) 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
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
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
Genzyme (GENZ)’s Cerdelga (eliglustat) Capsules Approved In Japan 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
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
Ariad (ARIA) And Medison Pharma Ltd. Announce Approval Of Iclusig (Ponatinib) In Israel 3/24/2015
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
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)'s Sandoz Bags Approval for First Biosimilar to be Sold in the U.S. 3/9/2015
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) 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
Sanofi (SAN.PA) Wins FDA Approval for New Insulin Drug Toujeo 2/27/2015
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
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
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
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
CrystalGenomics Receives MFDS Approval For Acelex® (Polmacoxib) 2/5/2015
Swedish Orphan Biovitrum Release: Xiapex Approved By The EU Commission For The Treatment Of Peyronie's Disease 1/30/2015
Moberg Pharma AB (Formerly known as Moberg Derma)'s Fungal Nail Product Approved In China 1/27/2015
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
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
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
China Approves World's First Inactive Sabin Strain Polio Vaccine 1/20/2015
Boehringer Ingelheim Corporation Release: OFEV® (Nintedanib*) Approved In The EU For The Treatment Of IPF 1/19/2015
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
Novartis AG (NVS) Receives Approval In Canada For Fluad Pediatric™, The First Vaccine Designed To Help Better Protect Infants From Seasonal Flu 1/7/2015
Actavis (ACT), Adamas Pharmaceuticals (ADMS) Win FDA Approval for Alzheimer's Drug Namzaric 1/5/2015
FDA Denies Approval for Actavis (ACT)' Hypertension Combo Treatment 12/30/2014
Actavis (ACT) Confirms Complete Response Letter For Nebivolol/Valsartan Fixed-Dose Combination For Hypertension 12/29/2014
FDA Approves Novo Nordisk A/S (NVO)'s Weight Management Drug Saxenda 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
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
AbbVie (ABBV) Receives Health Canada Approval Of HOLKIRA™ PAK For The Treatment Of Chronic Genotype 1 Hepatitis C 12/23/2014
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
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
FDA Approves Novartis AG (NVS) Drug For Rare Hormonal Disorder 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
Orexo AB (ORXOF): FDA Approves Two Higher Dosage Strengths Of ZUBSOLV® 12/12/2014
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
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
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
Novartis AG (NVS) Drug Signifor Approved In EU, Marking An Advance For Patients With Inadequately Controlled Acromegaly 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
FDA Approves Roche (RHHBY)’s Avastin Plus Chemotherapy To Treat Women With Platinumresistant Recurrent Ovarian Cancer 11/17/2014
pSivida Corp (PSDV) Reports ILUVIEN® Granted Marketing Authorization In Belgium 11/12/2014
Dr. Reddy's Laboratories Ltd. (RDY) Wins FDA Approval For Roche (RHHBY) Drug Generic 11/7/2014
Glenmark Generics Receives Final ANDA Approval For Omeprazole DR Capsules 11/5/2014
Vectura Group plc (VEC.L) Approval In Baltics For Innovative Respiratory Inhaler AirFluSal® Forspiro® 11/4/2014
Admedus Cardiocel® Gains Special Access In Singapore 11/3/2014
FDA Panel Backs Daiichi Sankyo, Inc. (4568.t)'s New A-Fib Drug Savaysa 10/31/2014
AstraZeneca PLC (AZN) Wins FDA Approval For Two-In-One Diabetes Pill 10/31/2014
TWi Pharmaceuticals, Inc. Receives U.S. FDA Approval On Generic Donepezil Hydrochloride Tablets USP, 23 Mg, Its Fifth ANDA From U.S. FDA 10/30/2014