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

Clinical - Approvals (World)
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
FDA Green Lights Alkermes (ALKS)' Schizophrenia Treatment Aristada 10/7/2015
Avita Medical Snags CE Mark for ReGenerCell and ReNovaCell to Complete Skin Healing Portfolio 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
Europe Approves Clinuvel's Novel Australian Drug Developed For Rare Sun Disease 10/24/2014
AstraZeneca PLC (AZN)'s Cancer Drug Pipeline Gets Boost From European Green Light 10/24/2014
Ferring Pharmaceuticals: CORTIMENT® MMX®, A New Treatment For Ulcerative Colitis, Receives European Approval 10/22/2014
Santen Announces Positive Outcome Of The European Decentralized Procedure For Approval Of TAPTIQOM® 10/22/2014
China Biologic Products Awarded CFDA Approval To Manufacture Plasma Product 10/20/2014
Pharmacyclics, Inc. (PCYC) Release: IMBRUVICA® (ibrutinib) Now Approved In Europe for Treatment Of Two Blood Cancers 10/17/2014
InterMune, Inc. (ITMN) Wins FDA Approval For Lung Drug At Center Of Roche (RHHBY) Deal 10/17/2014
Boehringer Ingelheim Corporation Wins FDA Approval For Lung Disease Drug Ofev 10/17/2014
ViiV Healthcare Receives Approval For Triumeq™ (dolutegravir/abacavir/lamivudine), In Canada - A New Once-Daily Single-Pill Regimen For The Treatment Of HIV 10/14/2014
Eisai Inc. (ESALF.PK) Grabs FDA Approval For Chemotherapy Side Effect Drug AKYNZEO® 10/13/2014
FDA Approves Eisai Inc. (ESALF.PK) Drug For Chemotherapy-Associated Nausea 10/10/2014
Novartis AG (NVS) Release: (Pr)Lucentis® (ranibizumab) Approved By Health Canada To Treat Vision Loss Resulting From Choroidal Neovascularization In Pathologic Myopia (mCNV)(1) 10/8/2014
Ganeden Biotech Release: GanedenBC30 Probiotic Approved In Japan, Taiwan, India & Philippines 10/6/2014
Celgene (CELG) Announces The Swissmedic Approval Of ABRAXANE® For Treatment Of Both Metastatic Pancreatic And Breast Cancers 9/25/2014
EPIRUS’ Remicade® Biosimilar Receives Final Approvals In India 9/16/2014
ThromboGenics NV (TBGNF)' JETREA® Gains Approval In South Korea 9/8/2014
China’s Food And Drug Administration Has Cleared NovaBay Pharmaceuticals, Inc. (NBY)’s Neutrophase Skin And Wound Cleanser For Sale Throughout Mainland China By NovoBay’s Partner, China Pioneer Pharma 9/3/2014
New Indication For VIMPAT® (Lacosamide): UCB Group (UCBJF.PK)'s Anti-Epileptic Drug Approved By FDA As Monotherapy In The Treatment Of Patients With Partial-Onset Seizures 9/2/2014
GE Healthcare Announces European Union Approval Of VIZAMYL™ (Flutemetamol (18F) Solution For Injection) For PET Imaging Of Beta Amyloid Plaque In Suspected Alzheimer’s Disease 9/2/2014
TWi Pharmaceuticals, Inc. Receives FDA Final Approval On Generic Megestrol Acetate 125mg/Ml Oral Suspension 8/28/2014
Biogen Idec, Inc. (Massachusetts) (BIIB) Release: Health Canada Approves Eloctate™, The First Therapy To Extend The Interval Between Prophylactic Infusions In Hemophilia A 8/26/2014
GlaxoSmithKline (GSK)-Pfizer Inc. (PFE)'s ViiV Healthcare Wins Approval For HIV Combo Drug 8/25/2014
GlaxoSmithKline (GSK)'s Asthma Treatment Wins FDA Approval 8/21/2014
Amerigen Pharmaceuticals Announces That Its Chinese Subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., Has Received Chinese FDA (CFDA) Approval And Has Subsequently Launched Its Generic Mecobalamin 0.5 Mg Tablets Into The China Domestic Market 8/20/2014
NanoString Technologies Inc. (NSTG) Receives Market Approval From The Australian Therapeutic Goods Administration For Its Prosigna Breast Cancer Prognostic Gene Signature Assay 8/6/2014
Health Canada Approves Celgene Corporation (CELG)'s ABRAXANE® Plus Gemcitabine For First-Line Treatment Of Patients With Metastatic Pancreatic Cancer 8/6/2014
European Commission (EC) Approves Roche (RHHBY)’s Avastin For Platinum-Resistant Recurrent Ovarian Cancer 8/6/2014
FDA Approves Boehringer Ingelheim Pharmaceuticals, Inc.'s Once-A-Day Inhaler Drug Striverdi For Chronic Lung Disease Patients 8/1/2014
Vertex Pharmaceuticals Incorporated (VRTX) Receives European Approval For KALYDECO™ (ivacaftor) In Eight Non-G551D Gating Mutations 8/1/2014
FDA Green Lights Boehringer Ingelheim Corporation, Eli Lilly and Company (LLY)'s Jardiance For Type 2 Diabetes 8/1/2014
Roche (RHHBY)’s Gazyvaro Approved In Europe For Patients With The Most Common Type Of Leukemia 7/29/2014
European Medicines Agency (EMA) Issues Positive Opinion, Recommends Full Approval Of IMBRUVICA® (Ibrutinib) For Treatment Of Two Blood Cancers 7/25/2014