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Clinical - Marketing Authorization Application (MAA)
Dipharma Announces The Validation Of Disanit (Nitisinone) Marketing Authorization Application In Europe 2/24/2017
Janssen-Cilag AG Release: DARZALEX (Daratumumab) Receives Positive CHMP Opinion For The Treatment Of Multiple Myeloma In Patients Who Have Received At Least One Prior Therapy 2/24/2017
Adapt Pharma Announces European Marketing Application Filed For Naloxone Hydrochloride Nasal Spray 2/21/2017
Armetheon Announces EMA's Support For 1000 Patient Single Phase lll Study Prior To MAA Filing For Its Novel Oral Anticoagulant Tecarfarin 2/14/2017
Ariad (ARIA) Announces Submission Of Marketing Authorization Application For Brigatinib To EMA 2/6/2017
Foresee Pharma Announces Successful Completion Of Scientific Advice Discussions With German Federal Institute For Drugs And Medical Devices (BfArM) For FP-001 LMIS 50 Mg 2/6/2017
Biocryst (BCRX) Announces The Acceptance Of Peramivir MAA Filing By The EMA 1/30/2017
Amgen (AMGN) Receives Positive CHMP Opinion For Abp 501 (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases 1/27/2017
Celgene (CELG) Receives Positive CHMP Opinion To Expand REVLIMID (Lenalidomide) Indication As Monotherapy For The Maintenance Treatment Of Patients With Newly Diagnosed Multiple Myeloma (MM) After Autologous Stem Cell Transplantation 1/27/2017
Pfizer (PFE) Receives Positive CHMP Opinion In Europe For XELJANZ (Tofacitinib Citrate) For The Treatment Of Moderate To Severe Active Rheumatoid Arthritis 1/27/2017
AbbVie (ABBV) Release: EMA Grants Accelerated Assessment, Validates Marketing Authorization Application For Pharma's Investigational Regimen Of Glecaprevir/Pibrentasvir (G/P) For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6) 1/24/2017
Enanta Pharmaceuticals, Inc. Release: Pharma Announces EMA Grants Accelerated Assessment, Validates Marketing Authorization Application For AbbVie (ABBV)’s Investigational HCV Regimen Of Glecaprevir/Pibrentasvir (G/P) For The Treatment Of All Major Genotypes (GT1-6) Of Chronic Hepatitis C 1/24/2017
Novelion (AEGR) Release: Biotech Announces Acceptance Of Marketing Authorization Application For Metreleptin By EMA 1/23/2017
Gilead (GILD) Release: EMA Validates Company’s Marketing Authorization Application For Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) 1/20/2017
Boehringer Ingelheim Release: Company's Biosimilar Candidate To Humira® Accepted For EMA And FDA Regulatory Review 1/18/2017
Oncurious Release: Company Announces European Commission (EC) Confirmed Orphan Medicinal Product Designation For TB-403 For Medulloblastoma 1/17/2017
European Commission (EC) Grants Marketing Authorization For Gilead (GILD)’s Vemlidy (Tenofovir Alafenamide, TAF) For The Treatment Of Chronic Hepatitis B Virus Infection 1/11/2017
Duchesnay Release: Company Is Pleased To Announce That Health Canada Has Granted Market Authorization For Mictoryl/Mictoryl Pediatric 1/10/2017
PTC Therapeutics (PTCT) Release: European Commission (EC) Ratifies Positive CHMP Opinion For The Renewal Of Translarna Marketing Authorization For The Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy 1/10/2017
Aralez Submits Marketing Authorization Application To The EMA For PA10040 1/9/2017
CSL Behring Release: AFSTYLA, For Haemophilia A, Receives European Commission Approval 1/9/2017
Alexion (ALXN) Submits U.S. And EU Applications Seeking Approval Of Soliris (Eculizumab) As A Treatment For Patients With Refractory Generalized Myasthenia Gravis (gMG) 1/9/2017
Portola (PTLA) Announces FDA Accepts New Drug Application For Priority Review And EMA Validates Marketing Authorization Application For Oral, Factor Xa Inhibitor Anticoagulant Betrixaban 12/27/2016
TiGenix Submits Day 120 Responses To EMA For Cx601 Marketing Authorization 12/27/2016
Novelion (AEGR)’s Subsidiary Files for European Approval for Metreleptin as a treatment for Generalized Lipodystrophy and a Subset of Patients with Partial Lipodystrophy 12/22/2016
Sarepta (SRPT) Announces EMA Validation Of Eteplirsen Authorization Application For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon Skipping 51 12/20/2016
European Commission (EC) Grants Intercept Pharma (ICPT)’s Ocaliva (Obeticholic Acid) Marketing Authorization For The Treatment Of Primary Biliary Cholangiti 12/14/2016
Regeneron (REGN) And Sanofi (SNY)i Announce Marketing Authorization Application For Dupixent (Dupilumab) Accepted For Review By The EMA 12/8/2016
Theravance Biopharma (TBPH) Highlights Filing Of EU Regulatory Submission For The Closed Triple In COPD By GlaxoSmithKline (GSK) And Innoviva 12/5/2016
GlaxoSmithKline (GSK) Files Regulatory Submission In European Union For Once-Daily Closed Triple Combination Therapy FF/UMEC/VI For Patients With COPD 12/2/2016
Amgen (AMGN) And Allergan (AGN) Submit Biosimilar Marketing Authorization Application To European Medicines Agency For ABP 215, A Biosimilar Candidate To Bevacizumab 12/2/2016
MorphoSys AG Announces That Its Licensee Janssen R&D Has Submitted A Marketing Authorization Application For Guselkumab In Europe 11/28/2016
Takeda Pharmaceutical Co. Ltd. (TKPYY) Release: NINLARO (Ixazomib) Receives Conditional Approval From The European Commission (EC) To Treat Multiple Myeloma 11/28/2016
Neurim Pharmaceuticals Grants Aspen Pharmacare Australia Marketing Rights For Paediatric Prolonged-Release Melatonin ("PedPRM") In Australia And New Zealand 11/16/2016
Easton Pharmaceuticals (OP: EAPH) Announces Receipt Of All Technical Documents From Biolyse Pharma For Filing Of A Marketing Authorization Dossier Towards Fast Track Approval With The Mexican Ministry Of Health For Cancer Drug Paclitaxel 11/16/2016
ERYtech Pharma Withdraws App for GRASPA After the CHMP Calls for More Data 11/15/2016
AbbVie (ABBV)'s HUMIRA (Adalimumab) Receives CHMP Positive Opinion To Treat Adolescents With Hidradenitis Suppurativa, A Chronic Inflammatory Skin Disease 11/14/2016
CSL Behring Release: AFSTYLA, For Haemophilia A, Receives Positive Opinion From EMA CHMP 11/14/2016
Bay Area's Ultragenyx (RARE) Shelves Plan for a Quick Approval for Rare Disease Drug in Europe 11/11/2016
European CHMP Adopts Positive Opinion For Gilead (GILD)’s Vemlidy (Tenofovir Alafenamide, TAF) For The Treatment Of Chronic Hepatitis B Virus Infection 11/11/2016
Mylan (MYL) And BioCon (BIOCON.NS) Announce Regulatory Submission For Insulin Glargine Accepted For Review By EMA 11/3/2016
Mundipharma AG Announces EU Regulatory Submission For Nyxoid 11/2/2016
Merck KGaA (MKGAF.PK) Release: EMA Validates The Marketing Authorization Application For Avelumab For The Treatment Of Metastatic Merkel Cell Carcinoma 10/31/2016
Becton, Dickinson and Company (BDX) MAX Vaginal Panel Receives FDA Market Authorization To Detect Most Common Causes Of Vaginal Infections 10/31/2016
Tesaro (TSRO) Announces Acceptance For Review Of Niraparib Marketing Authorization Application By EMA 10/28/2016
Biogen (BIIB)'s Regulatory Applications For Nusinersen As A Treatment For Spinal Muscular Atrophy Accepted By FDA And EMA 10/28/2016
The EMA Accepts To Assess The Marketing Authorization Application From PharmaMar For Aplidin 10/28/2016
PharmaEngine, Inc. Announces Onivyde Receives European Marketing Authorization For The Treatment Of Metastatic Adenocarcinoma Of The Pancreas Following Gemcitabine Based Therapy 10/18/2016
Shire (SHPG) Granted EU Marketing Authorization Of Onivyde, In Combination With 5-Fluorouracil (5-FU) And Leucovorin (LV),For The Treatment Of Metastatic Adenocarcinoma Of The Pancreas In Adult Patients Who Have Progressed Following Gemcitabine-Based Therapy 10/18/2016
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion for Opdivo (nivolumab) for the Treatment of Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma After Autologous Stem Cell Transplant and Treatment With Brentuximab Vedotin 10/14/2016
Intercept Pharma (ICPT) Gains Positive CHMP Opinion for Ocaliva 10/14/2016
EMA Committee Conditionally Approves AbbVie (ABBV)'s Leukaemia Drug VENCLYXTO 10/14/2016
Allergan (AGN)'s BELKYRA (Deoxycholic Acid) Receives Marketing Authorisation In Sweden For The Treatment Of Moderate To Severe Fullness Under The Chin (Double Chin) 10/13/2016
Primex Pharma Files For Marketing Authorization For A Pediatric Sedative Medication 10/5/2016
Dipexium Pharmaceuticals (DPRX) Receives EMA Designation As A Small And Medium Enterprise 10/4/2016
Samsung Bioepis' Marketing Authorization Application For SB3 Trastuzumab Biosimilar Candidate Accepted For Review By EMA 10/4/2016
Mundipharma AG And Orexo (ORXOF) Announce EU Regulatory Submission For Zubsolv 10/4/2016
TRACON Pharma (TCON) Announces Successful Meetings With FDA And EMA For TRC105 (Carotuximab) In Angiosarcoma 10/3/2016
European Commission (EC) Approves Transfer Of Marketing Authorisation For Alprolix Sobi 10/3/2016
AB Science (AB.PA) Announces The Filing Of Masitinib In The Treatment Of Amyotrophic Lateral Sclerosis (ALS) To The EMA 9/30/2016
NeuroDerm (NDRM) Provides Updates On ND0612 Long-Term Safety Trial And Submission Of Marketing Applications 9/29/2016
Advanced Accelerator Applications Release: EMA Prematurely Announced Opinion On SomaKit TOC Kit Application 9/23/2016
PharmaMar Submits MAA To EMA For Aplidin For The Treatment Of Multiple Myeloma 9/22/2016
AstraZeneca PLC (AZN) Yanks Ovarian Cancer EU Application After 'Differences Of Opinion' With Regulators 9/22/2016
Apricus Biosciences (APRI) Announces Completion Of Transfer Of The Marketing Authorizations For Vitaros® In Finland And Denmark To Ferring Pharma 9/20/2016
Claret Medical Submits Marketing Application To FDA For US Clearance Of First Cerebral Protection System For Transcatheter Aortic Valve Replacement (TAVR) 9/20/2016
CHMP Recommends Approval Of Eli Lilly (LLY)'s Olaratumab, In Combination With Doxorubicin, For Advanced Soft Tissue Sarcoma 9/16/2016
Amgen (AMGN) Receives Positive CHMP Opinion For Parsabiv (Etelcalcetide) For The Treatment Of Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Hemodialysis 9/16/2016
Janssen-Cilag International NV (JNJ) Receives CHMP Positive Opinion For STELARA (Ustekinumab) Recommending Approval For The Treatment Of Moderately To Severely Active Crohn’s Disease In The European Union 9/16/2016
Repros Therapeutics (RPRX) Announces Submission Of MAA To The EMA For Enclomiphene In The Treatment Of Secondary Hypogonadism 9/13/2016
Janssen-Cilag AG Submits Marketing Authorisation Application For Darunavir-Based Single Tablet Regimen For Treatment Of HIV-1 To EMA 9/12/2016
Propanc Files Application For Orphan Medicinal Product Designation In The EU For Pancreatic Cancer 9/7/2016
Mylan (MYL) And BioCon (BIOCON.NS) Announce Regulatory Submission For Proposed Biosimilar Trastuzumab Accepted For Review By EMA 8/25/2016
Janssen-Cilag International NV (JNJ) Submits Application To EMA To Expand Use Of DARZALEX (Daratumumab) To Include Combination With Standard Of Care Regimens 8/23/2016
Puma Biotech (PBYI) Announces EMA Validation Of Marketing Authorization Application For PB272 (Neratinib) As Extended Adjuvant Treatment Of HER2-Positive Early Stage Breast Cancer In Europe 8/22/2016
European Commission (EC) Grants Marketing Authorization For Gilead (GILD)’s Once-Daily Truvada® For Reducing The Risk Of Sexually Acquired HIV-1 8/22/2016
Portola (PTLA) Announces Validation Of Marketing Authorization Application (MAA) By EMA For Indexxa (Andexanet Alfa), A Factor Xa Inhibitor Antidote 8/19/2016
European Commission (EC) Grants Marketing Authorization For Teva (TEVA)’s CINQAERO (Reslizumab) 8/18/2016
Apricus Biosciences (APRI) Announces Completion Of Transfer Of The United Kingdom Marketing Authorization For Vitaros To Ferring Pharma 8/15/2016
Sanofi (SNY) And Regeneron (REGN) Announce EMA Acceptance For Review Of Marketing Authorisation Application For Sarilumab 8/1/2016
European Commission (EC) Grants Marketing Authorization For Merck & Co. (MRK)’s ZEPATIER (Elbasvir/Grazoprevir) For The Treatment Of Chronic Hepatitis C Infection 7/29/2016
Biofrontera AG Receives Favourable CHMP Assessment For Field-Directed Therapy And Files BCC Application 7/28/2016
DNAtrix, Inc. Receives EMA PRIME Designation 7/27/2016
Shire (SHPG) Release: ONIVYDE Receives Positive CHMP Opinion For Treatment Of Patients With Metastatic Adenocarcinoma Of The Pancreas Who Have Progressed Following Gemcitabine Based Therapy 7/25/2016
PharmaEngine, Inc. Announces ONIVYDE Regimen Receives CHMP Positive Opinion For The Treatment Of Metastatic Pancreatic Cancer 7/25/2016
Merrimack (MACK) Announces ONIVYDE Regimen Receives Positive CHMP Opinion In European Union 7/25/2016
CHMP Grants Positive Opinion For Shorter Treatment Duration With AbbVie (ABBV)'s VIEKIRAX (Ombitasvir/Paritaprevir/Ritonavir Tablets) For Patients With Genotype 4 Chronic Hepatitis C With Compensated Cirrhosis (Child-Pugh A) 7/25/2016
Allergan (AGN) Receives Positive Opinion For Truberzi (Eluxadoline) For Treatment Of Irritable Bowel Syndrome With Diarrhoea (IBS-D) In Adults 7/25/2016
European CHMP Adopts Positive Opinion On Gilead (GILD)’s Type II Variation Application For Truvada For Reducing The Risk Of Sexually Acquired HIV 7/22/2016
Mylan (MYL) And BioCon (BIOCON.NS) Announce Regulatory Submission For Proposed Biosimilar Pegfilgrastim Accepted For Review By European Medicines Agency 7/21/2016
Lexicon Pharma (LXRX) Announces The Validation By The European Medicines Agency Of The Marketing Authorization Application For Telotristat Etiprate For The Treatment Of Carcinoid Syndrome 7/19/2016
Merck & Co. (MRK) Receives European Medicines Agency Acceptance For Review Of Marketing Authorization Application For Cladribine Tablets 7/18/2016
European Medicines Agency Committee Classifies Advaxis (ADXS)’ Axalimogene Filolisbac As An Advanced-Therapy Medicinal Product 7/18/2016
Samsung Bioepis' Marketing Authorization Application For SB5 Adalimumab Biosimilar Candidate Accepted For Review By European Medicines Agency 7/18/2016
Bristol-Myers Squibb (BMY) Announces Regulatory Updates For Opdivo (Nivolumab) In Previously Treated Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck 7/18/2016
SB5, An Adalimumab Biosimilar Referencing Humira, Accepted For Review By European Medicines Agency 7/18/2016
Ipsen (IPN.PA) Announces The Acceptance By The European Medicines Agency Of The Marketing Authorization Application For Telotristat Etiprate To Treat Carcinoid Syndrome Caused By Neuroendocrine Tumors, In Combination With Somatostatin Analogues 7/18/2016
European Commission (EC) Grants Marketing Authorization For Gilead (GILD)’s Epclusa (Sofosbuvir/Velpatasvir) For The Treatment Of All Genotypes Of Chronic Hepatitis C 7/8/2016
Shire (SHPG) Receives Extension Of Market Authorization In Europe For Revestive (Teduglutide) For The Treatment Of Paediatric Patients With Short Bowel Syndrome (SBS) 7/7/2016
Seattle Genetics (SGEN) Announces European Commission (EC) Approval Of ADCETRIS (Brentuximab Vedotin) As Consolidation Treatment In Post-Transplant Hodgkin Lymphoma 7/6/2016
TiGenix Reconfirms Its Strategic Focus On Its Allogeneic Stem Cell Platforms 7/5/2016
Speedy Review for Genentech (RHHBY)’s OCREVUS, Action Date December 28 6/29/2016
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



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