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Clinical - Marketing Authorization Application (MAA)
Puma Biotech (PBYI) Submits Marketing Authorization Application For PB272 (Neratinib) As Extended Adjuvant Treatment Of HER2-Positive Early Stage Breast Cancer In Europe 6/27/2016
Merck & Co. (MRK) Receives CHMP Positive Opinion For KEYTRUDA (pembrolizumab) For The Treatment Of Advanced Non-Small Cell Lung Cancer (NSCLC) 6/27/2016
Teva (TEVA) Receives CHMP Positive Opinion For CINQAERO (Reslizumab) 6/24/2016
European Commission (EC) Grants Marketing Authorization For Gilead (GILD)’s Single Tablet Regimen Odefsey (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) For The Treatment Of HIV 6/23/2016
Medical Developments International Limited Release: Vive La France: Regulatory Approval Received 6/22/2016
Mundipharma International Limited Release: Penthrox (Low Dose Methoxyflurane) Granted Marketing Authorization In France 6/21/2016
PaizaBio: China Approves Drug Marketing Authorization Holder Pilot Plan, Green Lights Pharmaceutical Contract Manufacturing Sector 6/20/2016
Kiadis Pharma Announces Its Decision To File For Marketing Authorization With European Medicines Agency For ATIR101 In Blood Cancers 6/2/2016
Biogen (BIIB) Receives Positive CHMP Opinion For TYSABRI (Natalizumab) Use In Highly Active RRMS Patients With Inadequate Response To Prior MS Therapy 5/31/2016
Amgen (AMGN) Receives Positive CHMP Opinion To Extend Indication Of Kyprolis (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma 5/27/2016
AbbVie (ABBV)'s HUMIRA (Adalimumab) Receives CHMP Positive Opinion To Treat Certain Forms Of Non-Infectious Uveitis, A Disease That Can Severely Impact Vision[1] 5/27/2016
Takeda (TKPYY) Receives Positive CHMP Opinion For ADCETRIS (Brentuximab Vedotin) As Consolidation Treatment In Post-Transplant Hodgkin Lymphoma 5/27/2016
Takeda (TKPYY) Provides Update On EU Marketing Authorization Application For NINLARO (Ixazomib) In Relapsed/Refractory Multiple Myeloma 5/27/2016
Merck & Co. (MRK) Receives Positive CHMP Opinion For ZEPATIER (Elbasvir And Grazoprevir) In The European Union 5/27/2016
European CHMP Adopts Positive Opinion For Gilead (GILD)’s Epclusa(Sofosbuvir/Velpatasvir) For The Treatment Of All Genotypes Of Chronic Hepatitis C 5/27/2016
Shire (SHPG) Receives Positive CHMP Opinion In Europe For Revestive (Teduglutide) For Paediatric Patients With Short Bowel Syndrome 5/27/2016
Allergan (AGN)'s BOTOX Vista (Botulinum Toxin Type A) Receives National Marketing Authorisation In Japan For Treatment Of Crow's Feet Lines In Adult Patients 5/24/2016
Pfizer (PFE) Announces European Medicines Agency Acceptance For Review Of Marketing Authorization Application For TRUMENBA (Meningococcal Group B Vaccine) 5/20/2016
European Medicines Agency/CHMP Adopts Positive Opinion For ITM's EndolucinBeta 5/10/2016
Baxalta (BXLT) Receives Positive Opinion From Europe’s CHMP For HYQVIA For Treat Pediatric Patients 5/2/2016
Biogen (BIIB) And AbbVie (ABBV) Receive Positive Opinion From The CHMP On ZINBRYTA (Daclizumab) For Treatment Of Multiple Sclerosis 4/29/2016
Janssen-Cilag International NV (JNJ)’s IMBRUVICA (ibrutinib) Receives Positive CHMP Opinion For Expanded Use In Previously Untreated Chronic Lymphocytic Leukaemia Patients 4/29/2016
AbbVie (ABBV) Release: European Medicines Agency Issues Positive Opinion For The Use Of IMBRUVICA (Ibrutinib) As A First-Line Treatment For Chronic Lymphocytic Leukemia Patients 4/29/2016
European CHMP Adopts Positive Opinion For Gilead (GILD)’s TAF-Based Single Tablet Regimen Odefsey (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) For Treatment Of HIV 4/29/2016
Allergan (AGN) Receives CHMP Positive Opinion For ENZEPI (Pancrelipase) For Patients With Exocrine Pancreatic Insufficiency (EPI) 4/29/2016
European Commission (EC) Grants Marketing Authorization For Gilead (GILD)’s Fixed-Dose Combination Descovy (Emtricitabine, Tenofovir Alafenamide) For Treatment Of HIV 4/25/2016
Baxter International (BAX) Receives Marketing Authorization In The United Kingdom And Denmark For NUMETA G13E Ready-To-Use IV Nutrition For Preterm Newborns 4/20/2016
Pfizer (PFE) Receives European Approval For New Multi-Dose Vial Presentation Of Prevenar 13 4/6/2016
European Medicines Agency Grants Accelerated Assessment Of Marketing Authorization Application For Xilonix, XBiotech USA (XBIT)h’s True Human Therapeutic Antibody Treatment For Advanced Colorectal Cancer 4/4/2016
Amicus (FOLD) Receives Positive CHMP Opinion For Approval Of Migalastat In Patients With Fabry Disease In European Union 4/1/2016
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion For Opdivo (Nivolumab) In Combination With Yervoy (Ipilimumab) For Treatment Of Advanced Melanoma 4/1/2016
Janssen-Cilag International NV (JNJ) Receives CHMP Positive Opinion For TREVICTA (Paliperidone Palmitate A 3-Monthly Injection) Recommending Approval In The European Union For The Maintenance Treatment Of Schizophrenia 4/1/2016
CHMP Issues A Positive Opinion On Janssen-Cilag International NV (JNJ)’s Single-Agent DARZALEX (Daratumumab) 4/1/2016
Biogen (BIIB) Release: FLIXABI, An Infliximab Biosimilar Candidate Referencing Remicade, Receives Positive CHMP Opinion 4/1/2016
Genmab A/S (GEN.CO) Release: CHMP Issues Positive Opinion Recommending DARZALEX(r) (daratumumab) For Relapsed And Refractory Multiple Myeloma 4/1/2016
Samsung Bioepis' Flixabi Infliximab Biosimilar Recommended For Approval In The European Union 4/1/2016
Kamada Ltd. (KMDA) Submits Marketing Authorization Application With European Medicines Agency For Its Proprietary Inhaled Alpha-1 Antitrypsin To Treat Alpha-1 Antitrypsin Deficiency 3/28/2016
Pfizer (PFE) Announces European Medicines Agency Accepted For Review Its Marketing Authorization Application For XELJANZ (Tofacitinib Citrate) For The Treatment Of Moderate To Severe Rheumatoid Arthritis 3/24/2016
XBiotech Announces European Medicines Agency Validates Marketing Authorization Application (MAA) For Xilonix In The Treatment Of Advanced Colorectal Cancer 3/23/2016
Tesaro (TSRO) Announces Validation Of Marketing Authorization Application For Oral Rolapitant By European Medicines Agency 3/23/2016
Can-Fite BioPharma (CFBI) Submits Phase III Protocol Design And Registration Plan To European Medicines Agency For CF101 In The Treatment Of Rheumatoid Arthritis 3/17/2016
XBiotech Announces Submission Of Marketing Authorization Application (MAA) For Candidate Colorectal Cancer Therapy To European Medicines Agency 3/8/2016
European Medicines Agency Grants Eligibility For Submission Of XBiotech’s Marketing Authorization Application (MAA) 3/4/2016
Baxalta (BXLT) Submits Marketing Authorization Application To The European Medicines Agency For ADYNOVI For Treatment Of Hemophilia A Patients 3/2/2016
TiGenix Submits MAA To European Medicines Agency For Cx601 For The Treatment Of Complex Perianal Fistulas In Crohn's Disease Patients 3/2/2016
EUSA Pharma And AVEO Oncology (AVEO) Announce Submission Of Marketing Authorization Application For Tivozanib In Advanced Renal Cell Carcinoma 3/1/2016
CHMP Issues Positive Opinion For LONSURF (trifluridine/tipiracil) For Refractory Metastatic Colorectal Cancer 2/29/2016
AbbVie (ABBV) Receives European Medicines Agency Orphan Drug Designation For Investigational Compound Venetoclax For The Treatment Of Acute Myeloid Leukemia (AML) 2/26/2016
Eli Lilly (LLY) Receives Positive CHMP Opinion For Ixekizumab For The Treatment Of Moderate-To-Severe Plaque Psoriasis 2/26/2016
AbbVie (ABBV) Receives CHMP Positive Opinion For VIEKIRAX (Ombitasvir/Paritaprevir/Ritonavir Tablets) + EXVIERA (Dasabuvir Tablets) Without Ribavirin For The Treatment Of Chronic Hepatitis C In Genotype 1b Patients With Compensated Cirrhosis (Child-Pugh A) In Europe 2/26/2016
Enanta Pharmaceuticals, Inc. Announces CHMP Positive Opinion For AbbVie (ABBV)’s VIEKIRAX + EXVIERA® Without Ribavirin For The Treatment Of Chronic Hepatitis C In Genotype 1b Patients With Compensated Cirrhosis 2/26/2016
European CHMP Adopts Positive Opinion For Gilead (GILD)’s Fixed-Dose Combination Descovy (Emtricitabine/Tenofovir Alafenamide) For The Treatment Of HIV 2/26/2016
European Medicines Agency Validates Gilead (GILD)’s Marketing Application For Tenofovir Alafenamide (TAF) For The Treatment Of Chronic Hepatitis B 2/25/2016
XTL Biopharma (XTLB) Receives European Medicines Agency's SME Status 2/22/2016
AVEO Oncology (AVEO) Acceptance Of Registration Dossier For Tivozanib In RCC By The Ministry Of Health Of The Russian Federation 2/22/2016
FibCLOT, Human Fibrinogen From LFB S.A., Obtains First Marketing Authorizations In Europe 2/22/2016
Aratana Therapeutics (PETX) Files For First European Approval 2/18/2016
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



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