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Clinical - Marketing Authorization Application (MAA)
Oasmia Has Submitted A Marketing Authorization Application To The European Medicines Agency For Its Lead Cancer Product Apealea (Paclical) 2/8/2016
European Medicines Agency Validates Gilead (GILD)’s Type II Variation Application For Truvada® For Reducing The Risk Of Sexually Acquired HIV 2/1/2016
Exelixis (EXEL) Announces European Medicines Agency Acceptance Of Marketing Authorization Application For Cabozantinib As A Treatment Foradvanced Renal Cell Carcinoma 1/29/2016
Merck & Co. (MRK) Announces FDA Acceptance Of Biologics License Application For Bezlotoxumab, An Investigational Antitoxin For Prevention Of Clostridium Difficile Infection Recurrence 1/27/2016
Steba Biotech Completes Its European Phase 3 Clinical Trial Of TOOKAD In Patients With Low-Risk Prostate Cancer And Submits Marketing Authorization Application To The European Medicines Agency 1/25/2016
Baxalta (BXLT) Granted EU Marketing Authorization For ONCASPAR (Pegaspargase) As A Component Of Combination Therapy In Acute Lymphoblastic Leukaemia (ALL) 1/19/2016
Cardiome Pharma Corp. (COM.TO) Announces Filing Of Marketing Authorization Application For Intravenous Vernakalant In The Kingdom Of Saudi Arabia 1/13/2016
Exelixis (EXEL) Submits Marketing Authorization Application In The European Union For Cabozantinib As A Treatment For Advanced Renal Cell Carcinoma 1/11/2016
PTC Therapeutics (PTCT) Completes Rolling NDA Submission To FDA And Submits Phase 3 ACT DMD Clinical Trial Results To European Medicines Agency for Translarna (ataluren) For Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy 1/8/2016
Cardiome Pharma Corp. (COM.TO) And SteadyMed (STDY) Announce Decision For Centralized Review Of Trevyent By The European Medicines Agency 1/6/2016
Repros Therapeutics (RPRX) Updates Enclomiphene Program 1/5/2016
pSivida (PSDV) Files Early European Regulator for Eye Care Device, Possibly to FDA As Well 12/29/2015
European Medicines Agency Accepts Fanaptum (iloperidone) Marketing Authorization Application For The Treatment Of Schizophrenia In Adults 12/23/2015
AcelRx (ACRX) Receives Notice Of Eligibility For Centralized Review Of ARX-04 From European Medicines Agency 12/23/2015
CSL Behring Submits Marketing Authorization Application To The European Medicines Agency For RViii-SingleChain For Patients With Hemophilia A 12/22/2015
BioCad Scores Another Victory In mAb Biosimilars With Marketing Authorization For Bevacizumab 12/10/2015
Sunesis (SNSS) Announces Submission Of A Marketing Authorization Application For Vosaroxin For The Treatment Of Acute Myeloid Leukemia In Europe 12/8/2015
Amgen (AMGN) Submits Application In Europe To Expand Indication Of Kyprolis (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma 12/7/2015
Pharming Group (PHGUF.PK) Release: European Medicines Agency Reaffirms Important Health Benefits And Safety Of Ruconest For Patients With Hereditairy Angioedema 12/7/2015
Amgen (AMGN)'s First Biosimilar Marketing Authorization Application Submitted To European Medicines Agency For ABP 501 12/4/2015
European Medicines Agency Validates Gilead (GILD)’s Marketing Application For Fixed-Dose Combination Of Sofosbuvir/Velpatasvir For The Treatment Of Hepatitis C 12/4/2015
Baxalta (BXLT) Receives CHMP Positive Opinion For Sanquin To Begin Production, Enhancing Global Supply Of Plasma-Based Therapies 12/3/2015
FINOX Biotech’s Bemfola Receives Marketing Authorisation In Australia For Treatment Of Infertility 12/1/2015
Helsinn Announces European Medicines Agency Acceptance Of Marketing Authorization Application For Anamorelin HCL 11/30/2015
IMPAX Labs (IPXL) Receives European Commission (EC) Marketing Authorization For NUMIENT (Levodopa And Carbidopa) Modified-Release Capsules For The Symptomatic Treatment Of Adult Patients With Parkinson's Disease 11/25/2015
European Commission (EC) Approves Reconciliation Of Indications For Nivolumab Under The Opdivo European Marketing Authorization Application 11/24/2015
Baxalta (BXLT) Receives Positive CHMP Opinion For Use Of ONCASPAR (Pegaspargase) In European Union As A Component Of Combination Therapy In Acute Lymphoblastic Leukaemia (ALL) 11/23/2015
European Commission (EC) Grants Marketing Authorization For Gilead (GILD)’s Single Tablet Regimen Genvoya (Elvitegravir, Cobicistat, Emtricitabine And Tenofovir Alafenamide) For The Treatment Of HIV-1 Infection 11/23/2015
Radius Health (RDUS) Has Submitted A Marketing Authorization Application For The Investigational Drug Abaloparatide-SC For The Treatment Of Postmenopausal Osteoporosis In Europe 11/17/2015
Janssen-Cilag International NV (JNJ) Submits Application To The European Medicines Agency To Expand Use Of IMBRUVICA® (Ibrutinib) In Previously Untreated Chronic Lymphocytic Leukaemia Patients 11/3/2015
Ferring Pharmaceuticals Receives Acceptance Of Marketing Authorisation Filing From European Medicines Agency For Personalised Fertility Treatment With REKOVELLE (Follitropin Delta) 10/30/2015
FDA Indicates Deficiencies in Neos Therapeutics (NEOS)’s ADHD New Drug Application 10/20/2015
Merck & Co. (MRK) Release: KEYTRUDA (pembrolizumab) Receives New Draft Recommendation From National Institute For Health And Care Excellence (NICE) In U.K. For First-Line Treatment For Advanced Melanoma 10/9/2015
Aimmune (AIMT) Receives European Medicines Agency Decision Agreeing With PIP For AR101 For The Treatment Of Peanut Allergy 10/7/2015
Sunesis Pharmaceuticals, Inc. (SNSS) Announces Anticipated Submission Of European Marketing Authorization Application For Vosaroxin In AML Before Year End 10/7/2015
Ultragenyx (RARE) Announces Aceneuramic Acid Prolonged Release Marketing Authorization Application Filed And Accepted For Review By European Medicines Agency 10/2/2015
PTC Therapeutics (PTCT) Submits European Application For Translarna For Cystic Fibrosis 9/30/2015
Horizon Pharma (HZNP) Receives Positive CHMP Opinion For RAVICTI (Glycerol Phenylbutyrate) Oral Liquid For The Treatment Of Urea Cycle Disorders In Patients Greater Than Two Months Of Age 9/29/2015
Amgen (AMGN) Receives CHMP Positive Opinions For Two New Treatment Options For Patients With Blood Cancer In Europe 9/28/2015
Exelixis (EXEL) Release: European CHMP Adopts Positive Opinion For Cobimetinib In Combination With Vemurafenib For The Treatment Of Advanced Melanoma 9/25/2015
Vertex (VRTX) Receives CHMP Positive Opinions For ORKAMBI (Lumacaftor/Ivacaftor) And KALYDECO (Ivacaftor) In The European Union 9/25/2015
Celgene (CELG)’s VIDAZA (Azacitidine For Injection) Receives Positive CHMP Opinion As New Treatment For Elderly Patients With Acute Myeloid Leukemia 9/25/2015
European CHMP Adopts Positive Opinion For Gilead (GILD)’s Single Tablet Regimen Genvoya (Elvitegravir, Cobicistat, Emtricitabine And Tenofovir Alafenamide) For The Treatment Of HIV 9/25/2015
The The Medicines Company (MDCO) Receives CHMP Positive Opinion For IONSYS To Treat Post-Operative Pain In Adult Patients 9/25/2015
Novartis Europharm Ltd. Release: New Medicine To Treat Heart Failure Recommended For Approval 9/25/2015
Amgen (AMGN) Release: New Treatment Option For Patients With Rare Blood Cancer 9/25/2015
Boehringer Ingelheim Release: European Medicines Agency Fast-Tracks Antidote To Anticoagulant Pradaxa 9/25/2015
Biogen (BIIB) And Swedish Orphan Biovitrum Receive Positive Opinion From CHMP For Elocta (Rfviiifc) For The Treatment Of Hemophilia A 9/25/2015
CHMP Recommends EU Approval For Roche (RHHBY)’s Combination Of Cotellic (Cobimetinib) And Zelboraf (Vemurafenib) In Advanced Melanoma 9/25/2015
Biogen (BIIB) And Sobi Receive Positive Opinion From CHMP For ELOCTA (Rfviiifc) For The Treatment Of Hemophilia A 9/25/2015
Merck KGaA (MKGAF.PK), Darmstadt, Germany, And Pfizer (PFE) Announce FDA Orphan Drug Designation For Investigational Immunotherapy Avelumab In Merkel Cell Carcinoma 9/25/2015
Janssen-Cilag International NV (JNJ)’s Daratumumab Accepted For Accelerated CHMP Assessment For Treatment Of European Patients With Heavily Pre-Treated Multiple Myeloma 9/25/2015
Boehringer Ingelheim Release: CHMP Grants Positive Opinion For Idarucizumab, The Specific Reversal Agent For Dabigatran Etexilate (Pradaxa) 9/25/2015
AcelRx (ACRX) Reports That European Commission (EC) Has Granted Marketing Authorization For Zalviso For Treatment Of Acute Moderate-To-Severe Post-Operative Pain In Adult Patients 9/23/2015
First Marketing Authorizations In Europe For IQYMUNE, LFB S.A.’s 10% Liquid Intravenous Immunoglobulin 9/21/2015
ERYtech Pharma Submits EMA Marketing Authorization Application For GRASPA To Treat Acute Lymphoblastic Leukemia 9/15/2015
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Announce RIZAPORT (RHB-103) Marketing Authorization Application Is Approvable Under The European Decentralized Procedure 9/10/2015
Amgen (AMGN) Submits Marketing Authorization Application For Novel Intravenous Calcimimetic Etelcalcetide (AMG 416) To The European Medicines Agency 9/3/2015
Takeda (TKPYY) Announces European Medicines Agency Acceptance Of Ixazomib’s Marketing Authorization Application For Patients With Relapsed/Refractory Multiple Myeloma 8/21/2015
Janssen-Cilag International NV (JNJ) Submits European Extension Marketing Authorisation Application For Paliperidone Palmitate Once-Every-Three-Months Formulation 8/21/2015
European Medicines Agency Validates Gilead (GILD)’s Marketing Application For Single Tablet Regimen Containing Rilpivirine, Emtricitabine And Tenofovir Alafenamide (R/F/TAF) For HIV Treatment 8/21/2015
Pfizer (PFE) Announces European Medicines Agency Validates Marketing Authorization Application For IBRANCE (Palbociclib) In Combination With Endocrine Therapy For The Treatment Of HR+/HER2- Metastatic Breast Cancer 8/20/2015
United Therapeutics Corporation (UTHR) Release: European Commission (EC) Grants Marketing Authorisation For Unituxin (dinutuximab) For The Treatment Of Paediatric High-Risk Neuroblastoma 8/17/2015
Soligenix (SNGX) Receives Orphan Drug Designation From The European Commission (EC) For SGX301 As A Treatment For Cutaneous T-Cell Lymphoma 8/4/2015
Omeros Corporation (OMER) Release: Omidria Approved For Commercialization Throughout The European Union And Additional Countries 8/3/2015
Teva (TEVA) Announces European Medicines Agency Confirms Successful Validation Of Reslizumab Marketing Authorization Application 7/28/2015
Swissmedic Accepts For Review CSL Behring's MAA For rIX-FP For Patients With Hemophilia B 7/28/2015
Baxalta’s OBIZUR For Acquired Hemophilia A Receives Positive Opinion From European Committee For Medicinal Products For Human Use (CHMP) 7/27/2015
Merck & Co. (MRK) Receives Positive CHMP Opinion For Investigational Antibiotic ZERBAXA (Ceftolozane And Tazobactam) 7/27/2015
Bristol-Myers Squibb (BMY) Release: European Medicines Agency Validates And Grants Accelerated Assessment Of Marketing Authorization Application For Empliciti (Elotuzumab) For The Treatment Of Multiple Myeloma In Patients Who Have Received One Or More Prior Therapies 7/27/2015
Takeda Pharmaceuticals Release: European Medicines Agency Grants Accelerated Assessment Of Ixazomib For Patients With Relapsed/Refractory Multiple Myeloma 7/27/2015
GlaxoSmithKline (GSK) Wins Regulatory Go-Ahead for First Malaria Vaccine After 30 Year Quest 7/24/2015
Regeneron (REGN), Sanofi (SNY)'s Big New Cholesterol Drug Praluent Wins European Green Light 7/24/2015
Sunesis Pharmaceuticals, Inc. (SNSS) Announces Regulatory Update 7/24/2015
Keryx (KERX) Receives CHMP Positive Opinion For Fexeric (Ferric Citrate Coordination Complex) For The Treatment Of Hyperphosphatemia In Adults With Chronic Kidney Disease 7/24/2015
AcelRx (ACRX) Announces Positive CHMP Opinion For Zalviso In The Management Of Acute Moderate-To-Severe Post-Operative Pain In Adult Patients 7/24/2015
First Malaria Vaccine Receives Positive Scientific Opinion From European Medicines Agency 7/24/2015
European Medicines Agency Recommends Approval Of Treatment For Attention Deficit Hyperactivity Disorder 7/24/2015
Ligand (LGND) Release: Revolade Recommended By CHMP For EU Approval To Treat Patients With Severe Aplastic Anemia, A Serious Blood Disorder 7/24/2015
European Medicines Agency Release: Stimulating The Development Of Medicines For Children 7/23/2015
Bristol-Myers Squibb (BMY) Release: European Medicines Agency Validates Two Parallel Type II Variation Applications to Extend the Opdivo (nivolumab) Indication in Europe 7/23/2015
Merck & Co. (MRK) Announces European Medicines Agency Acceptance Of Marketing Authorization Application For Grazoprevir/Elbasvir, An Investigational Therapy For Treatment Of Chronic Hepatitis C Infection 7/23/2015
Hemispherx Biopharma Europe N.V./S.A. Submits Application For Orphan Medicine Designation To The European Medicines Agency For Alferon N Injection For Treatment Of Middle East Respiratory Syndrome (MERS) 7/15/2015
Daiichi Sankyo Release: NICE Recommends Once-daily LIXIANA (edoxaban) For The Treatment And Prevention Of Recurrent Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) In Adults 7/13/2015
Intercept Pharma (ICPT) Submits Applications In The U.S. And Europe For Marketing Approval Of Obeticholic Acid For The Treatment Of Primary Biliary Cirrhosis 6/30/2015
Theravance Biopharma Announces Marketing Authorization For VIBATIV (Telavancin) In Russia For Treatment Of Multiple Infections Caused By Gram-Positive Bacteria, Including MRSA 6/30/2015
CSL Behring Receives Positive CHMP Opinion For Respreeza (Human Alpha-1 Proteinase Inhibitor) As Maintenance Treatment For Patients With Severe Alpha-1 Antitrypsin Deficiency In Europe 6/29/2015
PharmaEngine, Inc. Release: MM-398 Receiving The Priority Review Designation By US FDA For New Drug Application And The Acceptance Of Market Authorization Application By EMA In Post-Gemcitabine Metastatic Pancreatic Cancer 6/26/2015
Amicus Therapeutics, Inc. (FOLD) Announces Galafold Marketing Authorization Application (MAA) Validated By European Medicines Agency 6/26/2015
BioMarin (BMRN) Announces European Medicines Agency Validates MAA For Drisapersen For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 6/26/2015
Biogen (BIIB) And Sobi Announce European Medicines Agency Validates Alprolix (Rfixfc) Marketing Authorization Application 6/26/2015
Roche (RHHBY)’s Perjeta Recommended For Approval In EU For Use Before Surgery In HER2-Positive Early Breast Cancer 6/26/2015
Biogen (BIIB) And Sobi Announce European Medicines Agency Validates ALPROLIX (rFIXFc) Marketing Authorization Application 6/26/2015
Alexion (ALXN) Receives CHMP Positive Opinions For Strensiq (Asfotase Alfa) And Kanuma (Sebelipase Alfa) In The European Union 6/26/2015
TiGenix Starts Cx601 Marketing Authorization Application Process 6/11/2015
BioMarin (BMRN) Submits Drisapersen MAA To European Medicines Agency For The Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 6/8/2015
Nearly-Dead AVEO Oncology (AVEO)'s Stock Jumps on Positive European Regulatory Promises 6/5/2015
ITM Group Release: Isotope Technologies Garching Announces Successful Validation of EndolucinBeta (n.c.a. Lutetium-177) Marketing Authorization Application By The European Medicines Agency 6/4/2015
Swedish Orphan Biovitrum's Partner Biogen (BIIB) Submits Marketing Authorisation Application For Alprolix (Rfixfc) In Europe 6/4/2015
DBV Tech Announces European Medicines Agency Paediatric Committee (PDCO) Positive Opinion On The Paediatric Investigation Plan For Viaskin Peanut For The Treatment Of Peanut Allergic Children 6/4/2015
Amicus Therapeutics, Inc. (FOLD) Submits Marketing Authorization Application (MAA) For Full Approval Of Fabry Monotherapy Galafold (Migalastat) In European Union 6/3/2015
Dipexium Pharmaceuticals (DPRX) Receives European Medicines Agency Scientific Advice On Clinical And Regulatory Pathway For Locilex Marketing Approval In European Union 6/2/2015
Stempeutics Receives Orphan Drug Designation (ODD) In The European Union For Its Novel Stem Cell Drug "Stempeucel" For The Treatment Of Thromboangiitis Obliterans 6/1/2015
European Medicines Agency Validates Gilead (GILD)’s Marketing Application For Fixed-Dose Combination Of Emtricitabine And Tenofovir Alafenamide For HIV Treatment 5/28/2015
Hemispherx Biopharma Europe N.V./S.A.: Orphan Medicine Designation And European Medicines Agency Public Opinion Summary Published By EMA Regarding Ampligen/Rintatolimod For Ebola Virus Disease (EVD) 5/26/2015
Amgen (AMGN) Beats Sanofi (SAN.PA) to Market with EU Hurdle for Anti-Cholesterol Drug 5/26/2015
Merck & Co. (MRK) Release: SIMPONI (golimumab) Gains Positive Opinion From Committee For Medicinal Products For Human Use (CHMP) For The Treatment Of Non-Radiographic Axial Spondyloarthritis 5/26/2015
Amgen (AMGN) Receives Positive CHMP Opinion For Use Of Repatha (Evolocumab) For The Treatment Of High Cholesterol 5/22/2015
Pharmacyclics (PCYC) Release: European Medicines Agency Issues Positive Opinion, Recommends Full Approval of IMBRUVICA (ibrutinib) To Treat Waldenstrom's Macroglobulinemia 5/22/2015
Janssen-Cilag International NV (JNJ) Release: STELARA Receives CHMP Positive Opinion For Treatment Of Adolescents With Moderate To Severe Psoriasis In Europe 5/22/2015
Omeros Corporation (OMER) Release: Omidria Receives Positive Opinion From European Medicines Agency's Committee For Medicinal Products For Human Use 5/22/2015
Merck & Co. (MRK) Receives Positive CHMP Opinion For KEYTRUDA (pembrolizumab) For The Treatment Of Advanced Melanoma 5/22/2015
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion In The European Union For Nivolumab (Opdivo, Nivolumab BMS) For The Treatment Of Advanced Squamous Non-Small Cell Lung Cancer In Previously-Treated Patients 5/22/2015
United Therapeutics Corporation (UTHR) Release: European Medicines Agency Recommends Treatment For Rare Cancer In Children 5/22/2015
Amgen (AMGN), Sanofi (SAN.PA) in Race to Get European Green light for Anti-Cholesterol Drugs 5/21/2015
Baxter International (BAX) Files For European Approval Of Investigational 20% Subcutaneous Immune Globulin Treatment For Primary Immunodeficiency 5/21/2015
European Medicines Agency Grants Kiadis Pharma's Lead Product ATIR ATMP Certificate For Quality And Non-Clinical Data 5/13/2015
EspeRare's Investigational Compound Rimeporide Receives European Orphan Drug Designation In Duchenne Muscular Dystrophy 5/4/2015
European Medicines Agency Grants Orphan Designation For Makindus' MI-100 For Stargardt's Disease 5/4/2015
Sobi Release: Early Treatment And A Longer Life - New Orfadin Formats Meet New Patient Needs 5/4/2015
PharmaEngine, Inc. Announces Filing By Baxter BioScience Corporation (BAX) Of Marketing Authorization Application Of MM-398 (PEP02) To The European Medicines Agency For Post-Gemcitabine Metastatic Pancreatic Cancer Patients 5/4/2015
Oncolytics Biotech Inc. (ONC.TO) Announces Receipt Of Orphan Drug Status From The European Medicines Agency For Pancreatic Cancer 4/29/2015
Valeant (VRX) Release: RELISTOR Receives Positive CHMP Opinion In The EU For The Treatment Of Opioid-Induced Constipation In Adults With Chronic Non-Cancer Pain 4/24/2015
Vanda Pharmaceuticals, Inc. (VNDA) Receives Positive CHMP Opinion For HETLIOZ (Tasimelteon) For The Treatment Of Non-24-Hour Sleep-Wake Disorder In The European Union 4/24/2015
Alimera Sciences (ALIM)' ILUVIEN Receives 17th European Marketing Authorization; Completing Second Wave Of Country Approvals 4/14/2015
Repros Therapeutics Inc. (RPRX) Receives Confirmation Of Eligibility For Submission Of A Centralized Marketing Authorization Application To The European Medicines Agency As A New Active Substance 4/7/2015
European Regulators Postpone Bristol-Myers Squibb (BMY)’s Opdivo Decision Until April or Later, As Markets Wait Anxiously 3/31/2015
Synageva BioPharma (GEVA) Submits Kanuma (Sebelipase Alfa) Application For LAL Deficiency In Mexico 3/30/2015
Helsinn Group Receives Positive CHMP Opinion For Akynzeo (netupitant/palonosetron) For The Prevention Of Chemotherapy Induced Nausea And Vomiting (CINV) In The European Union 3/30/2015
Boehringer Ingelheim Release: Type 2 Diabetes: CHMP Recommends Empagliflozin/Metformin Hydrochloride For Approval In The European Union 3/30/2015
Biogen (BIIB) Announces European Medicines Agency Validation Of Marketing Authorization Application For SB2, A Biosimilar Candidate For Infliximab 3/30/2015
European Medicines Agency Commences Review Of CSL Behring's Regulatory Submission For Rix-FP For Hemophilia B Patients 3/30/2015
Otsuka Pharmaceutical Co., Ltd. Release: Pre-Filled Dual-Chamber Syringe For Abilify Maintena (Aripiprazole) Prolonged-Release Suspension For Injection, Used In The Treatment Of Schizophrenia, Receives Positive CHMP Opinion (Approval In EU) 3/30/2015
European Medicines Agency Validates Marketing Authorisation Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment Of MS 3/27/2015
Santen Pharmaceutical Announces Approval Of Ikervis For EU Marketing Authorization 3/25/2015
Amicus Therapeutics, Inc. (FOLD) Provides Positive Global Regulatory Updates From European Medicines Agency And FDA Meetings For Fabry Monotherapy 3/19/2015
VAXIL Receives EU Orphan Drug Designation For Immucin For The Treatment Of Multiple Myeloma 3/16/2015
Samsung Bioepis Submits Marketing Authorization Application For SB2, A Remicade (Infliximab) Biosimilar Candidate, To The European Medicines Agency 3/13/2015
ThromboGenics NV (TBGNF) Receives Positive CHMP Opinion For Ready Diluted Formulation Of JETREA 3/3/2015
Taiho Pharmaceutical Submits TAS-102 Marketing Authorisation Application To The European Medicines Agency For The Treatment Of Refractory Metastatic Colorectal Cancer 3/2/2015
European Medicines Agency Accepts Santen, Inc.'s Marketing Application Filing For Intravitreal Sirolimus For The Treatment Of Noninfectious Uveitis Of The Posterior Segment 3/2/2015
Celgene International Sárl (CELG) Release: ABRAXANE Approved By European Commission For First-Line Treatment Of Patients With Non-Small Cell Lung Cancer 3/2/2015
European Medicines Agency Release: Novartis AG (NVS)'s Zykadia Recommended For Approval In Advanced Non Small Cell Lung Cancer 2/27/2015
Alexion Pharmaceuticals Inc. (ALXN) Receives CHMP Positive Opinions For Important Updates To The EU Label For Soliris (eculizumab) 2/27/2015
Amgen (AMGN) Announces The European Medicines Agency Acceptance Of Kyprolis (Carfilzomib) Marketing Authorization Application For The Treatment Of Relapsed Multiple Myeloma 2/27/2015
Roche (RHHBY)’s Avastin Plus Chemotherapy Receives Positive Recommendation From CHMP For EU Approval In Advanced Cervical Cancer 2/27/2015
Tolero Pharmaceuticals Receives European Medicines Agency Orphan Drug Designation For Alvocidib For The Treatment Of Acute Myeloid Leukemia 2/26/2015
Regeneron (REGN) Release: EYLEA (aflibercept) Injection Receives EU Approval For The Treatment Of Visual Impairment Due To Macular Edema Secondary To Retinal Vein Occlusion 2/26/2015
MediGene AG (MDGEF.PK) Receives Positive Decision On Marketing Authorisation For Veregen In 8 Additional European Countries 2/20/2015
aTyr Pharma Inc. Receives European Medicines Agency Orphan Drug Designation For Resolaris In FSHD 2/18/2015
Celgene (CELG) Announces Positive Recommendation By Scottish Medicines Consortium (SMC) For ABRAXANE (Nab-Paclitaxel) In Combination With Gemcitabine1 For Patients With Metastatic Pancreatic Cancer 2/10/2015
Orexigen Therapeutics, Inc. (OREX) Provides Progress Update on Mysimba European Marketing Authorization 2/9/2015
Arena Pharmaceuticals, Inc. (ARNA) Announces Marketing Approval In South Korea Of BELVIQ® (lorcaserin HCl) For Weight Management 2/3/2015
Sucampo Pharmaceuticals, Inc. (SCMP) Release: AMITIZA® (Lubiprostone) Mutual Recognition Procedure Closes With Recommendation For Approval In European Countries 1/30/2015
Amgen (AMGN) Submits Applications In The U.S. And Europe For Kyprolis (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma 1/29/2015
Amgen (AMGN) Submits Applications for Cancer Drug Kyprolis in U.S. and Europe 1/28/2015
BioDelivery Sciences International (BDSI) Acquires North American Marketing Authorizations For ONSOLIS From MEDA 1/27/2015
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization In Finland And Luxembourg 1/27/2015
Medunik Canada Is Pleased To Announce That Health Canada Has Granted Market Authorization For Pheburane™ 1/27/2015
pSivida Corp (PSDV) Reports ILUVIEN® Receives Marketing Authorization In Two More EU Countries 1/27/2015
Merck & Co. (MRK) Announces CHMP Issues Positive Opinion For Investigational Antibiotic SIVEXTRO® (Tedizolid Phosphate) 1/26/2015
The Medicines Company (MDCO) Receives CHMP Positive Opinions For Three Hospital Acute Care Products: KENGREXAL™ (cangrelor), ORBACTIV™ (oritavancin) And RAPLIXA™ (sealant powder) 1/23/2015
European Medicines Agency Release: Novo Nordisk A/S (NVO)'s Saxenda Recommended For Approval In Weight Management In Adults 1/23/2015
Pfizer (PFE) Release: Prevenar 13®* Receives CHMP Positive Opinion For Prevention Of Vaccine-Type Pneumococcal Pneumonia in Adults 1/22/2015
European Commission (EC) Grants Marketing Authorization For Cerdelga® (Eliglustat), Genzyme Corporation (GENZ)’s Oral Therapy For Gaucher Disease Type 1 1/22/2015
European Medicines Agency Accepts Samsung Bioepis' Enbrel® Biosimilar Candidate, SB4, For Regulatory Review 1/21/2015
Enanta Pharmaceuticals, Inc. Announces European Commission (EC) Grants Marketing Authorizations For AbbVie (ABBV)’s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets)... 1/16/2015
Celgene International Sárl (CELG) Release: Oral OTEZLA® (Apremilast) Approved By The European Commission For The Treatment Of Both Patients With Psoriasis And Psoriatic Arthritis 1/16/2015
European Commission (EC) Grants Marketing Authorizations For AbbVie (ABBV)'s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) For The Treatment Of Chronic Hepatitis C 1/16/2015
Regeneron (REGN) And Sanofi (SAN.PA) Announce Praluent™ (alirocumab) Marketing Authorization Application Has Been Accepted For Review By European Medicines Agency 1/12/2015
Ultragenyx Pharmaceuticals (RARE) Announces Intent To File For Conditional Approval In Europe For Sialic Acid Extended-Release Tablets In Hereditary Inclusion Body Myopathy 1/12/2015
Magnus Life Science Announces Recommendation For Orphan Designation 1/8/2015
AVEO Oncology (AVEO) Receives Confirmation Of Eligibility For Submission Of A Tivozanib Marketing Authorization Application To European Medicines Agency 1/8/2015
Shield Therapeutics Announces The Acceptance For Review By The European Medicines Agency Of The Marketing Authorisation Application For Feraccru® 1/7/2015
Newron Pharmaceuticals (NWRN) Release: CHMP Recommends Approval Of Xadago™ (Safinamide) To Treat Parkinson's Disease In The EU 1/7/2015
RedHill Biopharma Ltd. (RDHL) Announces Acceptance For Review Of BEKINDA™ European Marketing Application For Oncology Support 12/31/2014
BioSpecifics Technologies Corporation (BSTC) Announces Positive Opinion By CHMP For XIAPEX® For The Treatment Of Peyronie's Disease 12/23/2014
Rock Creek Pharmaceuticals Files Clinical Trial Application In The UK For Clinical Trials Of Anatabine Citrate Formulations 12/23/2014
Synageva BioPharma (GEVA) Announces Sebelipase Alfa Marketing Authorization Application Validated By The European Medicines Agency 12/23/2014
Actavis (ACT) Release: XYDALBA™ (dalbavancin) Receives CHMP Positive Opinion For The Treatment Of Acute Bacterial Skin And Skin Structure Infections (ABSSSI) In Adults 12/22/2014
Oncolytics Biotech Inc. (ONC.TO) Announces Filing For Orphan Designation With The European Medicines Agency For Pancreatic And Ovarian Cancers 12/22/2014
Eiger Bio Receives Orphan Designation For Lonafarnib, A First In Class, Investigational Treatment For Hepatitis Delta Virus (HDV) Infection 12/22/2014
Auxilium Pharmaceuticals (AUXL) Release: Sobi's Xiapex Receives Positive Opinion By CHMP For The Treatment Of Peyronie's Disease 12/22/2014
Orexigen Therapeutics, Inc. (OREX)'s Mysimba (Naltrexone Hcl / Bupropion Hcl Prolonged Release) Receives Positive CHMP Opinion Recommending Approval For Weight Management In The European Union 12/19/2014
Celgene (CELG) Receives Positive CHMP Opinion To Extend REVLIMID® (Lenalidomide) For Continuous Use In Patients With Newly Diagnosed Multiple Myeloma And Ineligible For Transplant 12/19/2014
Newron Pharmaceuticals (NWRN) Release: CHMP Recommends Approval Of Xadago (Safinamide) To Treat Parkinson´s Disease In The EU 12/19/2014
Ligand Pharmaceuticals Inc. (LGND) Partner Pfizer (PFE) Receives European Marketing Authorization For DUAVIVE® (Conjugated Estrogens/Bazedoxifene) For Treatment Of Estrogen Deficiency Symptoms In Postmenopausal Women With A Uterus 12/19/2014
Amicus Therapeutics, Inc. (FOLD) To Submit European Marketing Application For Migalastat Monotherapy For Fabry Disease 12/11/2014
RedHill Biopharma Ltd. (RDHL) Submits BEKINDA™ (RHB-102) European Marketing Authorization Application For Oncology Support 12/9/2014
GVK Biosciences Review: Some Member States Suspend Marketing Authorisations For Concerned Medicines 12/5/2014
NPS Pharmaceuticals, Inc. (NPSP) Release: European Medicines Agency Validates Marketing Authorization Application For Natpar® (Parathyroid Hormone (rDNA)) In Hypoparathyroidism 12/2/2014
Synageva BioPharma (GEVA) Completes Rolling Submission Of Biologics License Application To The FDA For Sebelipase Alfa And Submits Marketing Authorization Application To European Medicines Agency 12/2/2014
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Announce Acceptance For Review Of European Marketing Application For RIZAPORT For Migraines 12/1/2014
Alexion Pharmaceuticals Inc. (ALXN) Release: National Institute for Clinical Excellence (NICE) Issues Final Positive Recommendation For National Commissioning Of Soliris® (Eculizumab) For All Patients With aHUS In England 12/1/2014
Pharmacyclics, Inc. (PCYC) Release: New IMBRUVICA (ibrutinib) Application Accepted By European Medicines Agency For Waldenstrom's Macroglobulinemia 12/1/2014
Alimera Sciences (ALIM)' ILUVIEN Receives Marketing Authorization In The Netherlands For The Treatment Of Chronic Diabetic Macular Edema 12/1/2014
BioTie Therapies Corp.: UK's NICE Issues Positive Final Guidance For Selincro 11/26/2014
AbbVie (ABBV) Nabs Positive CHMP Opinions For VIEKIRAX Plus EXVIERA To Treat HCV 11/24/2014
Genzyme Europe BV Cerdelga Gets EU Recommended For Approval In Type 1 Gaucher Disease 11/21/2014
Celgene (CELG) Receives Positive CHMP Opinion For OTEZLA (apremilast), The First Oral PDE4 Inhibitor For The Treatment Of Patients With Psoriasis And Psoriatic Arthritis 11/21/2014



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