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Clinical - Marketing Authorization Application (MAA)
TetraPhase (TTPH) Announces Submission And Validation Of IV Eravacycline Marketing Authorization Application By EMA 8/17/2017
Puma Biotech (PBYI) Receives Day-180 List Of Outstanding Issues From Committee For Medicinal Products For Human Use (CHMP) 8/3/2017
Aclaris (ACRS) Submits Marketing Authorization Application In Europe For A-101 40% Topical Solution As A Novel Treatment For Seborrheic Keratosis 8/3/2017
Kite Pharma (KITE) Files The Industry’s First CAR-T Marketing Authorization Application In Europe For Axicabtagene Ciloleucel 7/31/2017
In Race, Kite Pharma (KITE) Slides Head-First to File CAR-T MAA in Europe 7/31/2017
European Commission (EC) Grants Marketing Authorization For Gilead (GILD)’s Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) For The Treatment Of All Genotypes Of Chronic Hepatitis C 7/28/2017
European Commission (EC) Grants AbbVie (ABBV)'s MAVIRET (Glecaprevir/Pibrentasvir) Marketing Authorization For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6) 7/28/2017
Akcea Therapeutics And Ionis Pharma (IONS) Announce Submission Of Marketing Authorization Application For Volanesorsen To The EMA 7/27/2017
Xbrane Biopharma: Spherotide Granted Market Authorization In Iran 7/24/2017
Bay Area Nektar (NKTR)' Comeback is Stalled as the EMA Rejects Breast Cancer Drug 7/21/2017
GlaxoSmithKline (GSK) Submits EU Filing For Extended Use Of Relvar Ellipta In Patients With Controlled Asthma On An ICS/LABA Combination 7/21/2017
Janssen-Cilag International NV (JNJ) Receives Positive CHMP Opinion For SYMTUZA The First Darunavir-Based Single-Tablet Regimen For The Treatment Of HIV 7/21/2017
Ipsen (IPN.PA) Receives Positive CHMP Opinion For Approval Of Xermelo (Telotristat Ethyl), For The Treatment Of Carcinoid Syndrome Diarrhea In Patients Inadequately Controlled By Somatostatin Analogue Therapy 7/21/2017
Merck KGaA (MKGAF.PK) Release: EMA's CHMP Issues Positive Opinion For Avelumab For The Treatment Of Metastatic Merkel Cell Carcinoma 7/21/2017
Vanda (VNDA) Receives Negative Opinion For Marketing Authorization From The EMA On Fanaptum For The Treatment Of Schizophrenia 7/21/2017
Cenegermin Eye Drops Receive European Union Approval: The First Biotechnological Drug Resulting From Dompe Research For The Treatment Of Moderate To Severe Neurotrophic Keratitis Is Made In Italy 7/21/2017
AbbVie (ABBV) Receives CHMP Positive Opinion For HUMIRA (Adalimumab) For The Treatment Of Pediatric Patients With Chronic Non-Infectious Anterior Uveitis 7/21/2017
EMA's CHMP Recommends Approval For Merck & Co. (MRK)’s KEYTRUDA (Pembrolizumab) For The Treatment Of Certain Patients With Locally Advanced Or Metastatic Urothelial Carcinoma, A Type Of Bladder Cancer 7/21/2017
Novartis AG (NVS) Receives Positive CHMP Opinion For Rydapt (Midostaurin) For Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) And Three Types Of Advanced Systemic Mastocytosis (SM) 7/21/2017
Sanofi (SNY) And Regeneron (REGN) Receive Positive CHMP Opinion For Dupixent (Dupilumab) To Treat Adult Patients With Moderate-To-Severe Atopic Dermatitis 7/21/2017
EU Regulators Give Nod to Advanced Accelerator Applications ' Med to Treat the Cancer That Killed Steve Jobs 7/21/2017
Lexicon Pharma (LXRX) Collaborator Ipsen (IPN.PA) Receives Positive CHMP Opinion For Xermelo (Telotristat Ethyl) 7/21/2017
LEO Pharma Receives Marketing Authorisation For Kyntheum (Brodalumab), A New Biologic For The Treatment Of Moderate-To-Severe Plaque Psoriasis In The European Union 7/20/2017
Evolus Announces EMA Acceptance For Review Of The Marketing Authorization Application For DWP-450 Neuromodulator 7/20/2017
CTI BioPharma Announces EMA Validation Of Pacritinib Marketing Authorization Application For Patients With Myelofibrosis Who Have Thrombocytopenia 7/14/2017
EMA Validates Gilead (GILD)’s Marketing Application For Fixed-Dose Combination Of Bictegravir, Emtricitabine And Tenofovir Alafenamide For Treatment Of HIV 7/13/2017
Cascadian Therapeutics (ONTY) Announces Positive Regulatory Update For Tucatinib In Europe 7/11/2017
Amgen (AMGN) Receives Positive CHMP Opinion To Expand Use Of Mimpara (cinacalcet) For The Treatment Of Secondary Hyperparathyroidism In Certain Children With End-Stage Renal Disease On Dialysis 6/26/2017
AVEO Oncology (AVEO) Announces Positive CHMP Opinion For Tivozanib As A Treatment Of Advanced Renal Cell Carcinoma 6/26/2017
Enanta Pharmaceuticals, Inc. Announces That AbbVie (ABBV) Receives CHMP Positive Opinion For MAVIRET (Glecaprevir/Pibrentasvir) For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6) 6/23/2017
EUSA Pharma Receive Positive Opinion From The CHMP For Tivozanib For The First-Line Treatment Of Advanced Renal Cell Carcinoma In The European Union 6/23/2017
European CHMP Adopts Positive Opinion For Gilead (GILD)’s Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) For The Treatment Of All Chronic Hepatitis C Genotypes 6/23/2017
Samsung Bioepis' Imraldi (Adalimumab) Recommended For Approval By EMA 6/23/2017
Biogen (BIIB)’s IMRALDI, An Adalimumab Biosimilar Candidate Referencing Humira, Granted Positive Opinion By Committee For Medicinal Products For Human Use 6/23/2017
AbbVie (ABBV) Receives CHMP Positive Opinion For MAVIRET (Glecaprevir/Pibrentasvir) For The Treatment Of Chronic Hepatitis C In All Major Genotypes (GT1-6) 6/23/2017
Alexion (ALXN) Receives Positive CHMP Opinion For Soliris (Eculizumab) For The Treatment Of Patients With Refractory Generalized Myasthenia Gravis (gMG) In The European Union 6/23/2017
Kamada (KMDA) WIthdraws MAA For Inhaled Alpha-1 Antitrypsin 6/22/2017
Shire (SHPG) Announces EMA Validation Of Veyvondi [Von Willebrand Factor (Recombinant)] Marketing Authorization Application For Treatment Of Von Willebrand Disease 6/22/2017
pSivida (PSDV) Submits Marketing Authorization Application (MAA) For Approval Of Durasert Three-Year Treatment For Posterior Segment Uveitis In The European Union 6/22/2017
Takeda (TKPYY) And TiGenix Announce That Swissmedic Has Accepted For Review The File On Cx601 For The Treatment Of Complex Perianal Fistulas In Crohn's Disease Patients 6/20/2017
Edge Therapeutics Receives Pediatric Investigation Plan Waiver From The EMA 6/8/2017
Sangamo (SGMO) And Pfizer (PFE) Announce That SB-525 Investigational Hemophilia A Gene Therapy Receives Orphan Medicinal Product Designation From The EMA 6/7/2017
Amgen (AMGN) Submits Regulatory Applications For Repatha (evolocumab) Cardiovascular Outcomes Data In U.S. And Europe 6/5/2017
Janssen Pharmaceutical Announces Submissions In Europe And U.S. For Single-Tablet Regimen Of Dolutegravir Plus Rilpivirine - The First Two-Drug HIV Maintenance Treatment 6/2/2017
Biogen (BIIB) Release: SPINRAZA (Nusinersen) Approved In The European Union As First Treatment For Spinal Muscular Atrophy 6/1/2017
Ionis Pharma (IONS) Release: SPINRAZA (Nusinersen) Approved In The European Union 6/1/2017
Mithra Pharmaceuticals Obtains Marketing Authorization For Tibelia In France 5/30/2017
Biogen (BIIB)’s FAMPYRA Granted Standard Marketing Authorization In European Union For Improvement Of Walking In People With MS 5/24/2017
Dompe Receives Positive CHMP Opinion In Europe For Oxervate (Cenegermin Eye Drops) For The Treatment Of Adult Patients With Moderate Or Severe Neurotrophic Keratitis 5/23/2017
Clinigen Achieves Positive CHMP Opinion Concerning Cardioxane In Europe 5/22/2017
Fujifilm Kyowa Kirin Biologics Announces Marketing Authorisation Application For FKB327 Accepted For Review By EMA 5/22/2017
Marketing Approval For Children’s Cancer Immunotherapy In The EU: Outstanding Success For Privately Financed Austrian Biotech Company APEIRON 5/10/2017
Apellis Pharma Receives EMA Orphan Drug Designation For APL-2 In PNH 5/9/2017
PharmaMar: Aplidin Receives Orphan Drug Status For The Treatment Of Multiple Myeloma In Switzerland 5/4/2017
Nymox (NYMX) Files For Marketing Approval For Fexapotide Triflutate In Europe 5/3/2017
Bay Area's Sunesis (SNSS) Drops After Withdrawing Leukemia Drug Application 5/2/2017
Genmab A/S (GEN.CO) Announces European Marketing Authorization For DARZALEX (Daratumumab) For Relapsed Or Refractory Multiple Myeloma 4/28/2017
Zoetis (ZTS) Receives European Commission (EC) Marketing Authorization For Cytopoint (lokivetmab) 4/27/2017
PIQUR Therapeutics AG Receives EMA Orphan Drug Designation For PQR309 In Diffuse Large B-Cell Lymphoma 4/27/2017
Shire (SHPG) Granted EU Conditional Marketing Authorisation For Natpar (Parathyroid Hormone) For The Treatment Of Patients With Chronic Hypoparathyroidism 4/26/2017
PhaseRx (PZRX) Receives Positive Opinion For Orphan Drug Designation For PRX-OTC From EMA 4/25/2017
BioMarin (BMRN) Receives Positive CHMP Opinion In Europe For Brineura (Cerliponase Alfa) For First Treatment Of CLN2 Disease, A Form Of Batten Disease And Ultra-Rare And Fatal Brain Disorder In Children 4/24/2017
Regeneron (REGN) And Sanofi (SNY) Receive Positive CHMP Opinion For Kevzara (Sarilumab) To Treat Adult Patients With Moderately To Severely Active Rheumatoid Arthritis 4/24/2017
Eyevensys Receives Approval From The UK Medicines And Healthcare Products Regulatory Agency To Advance its EyeCET Platform Into Clinical Development 4/20/2017
uniQure (QURE) Announces It Will Not Seek Marketing Authorization Renewal For Glybera In Europe 4/20/2017
Cleveland Biolabs Inc. (CBLI) Announces EMA Positive Opinion Regarding The Entolimod Pediatric Investigation Plan 4/17/2017
AVEO Oncology (AVEO) Announces Submission Of Response To Tivozanib Marketing Authorization Application Day 180 List Of Outstanding Issues 4/13/2017
RedHill Biopharma (RDHL) And IntelGenx Corp. Announce Marketing Approval Of RIZAPORT For Migraines In Luxembourg 4/13/2017
Amgen (AMGN) Submits Applications In The US And Europe To Expand Current Indication For XGEVA (Denosumab) To Include Patients With Multiple Myeloma 4/4/2017
Amgen (AMGN) Submits Applications In The US And Europe To Expand Current Indication For XGEVA (denosumab) To Include Patients With Multiple Myeloma 4/4/2017
bene-Arzneimittel Receives Positive CHMP Opinion For Elmiron For The Treatment Of Bladder Pain Syndrome In The European Union 4/3/2017
Guerbet (GBT) Concurs With The PRAC Recommendations On Gadolinium-Based Contrast Agents And Announces Changes To The US Labeling For Its Linear Agent Optimark (Gadoversetamide Injection) 3/31/2017
AcelRx (ACRX) Release: EMA Begins Evaluation Of Marketing Application For Sublingual Sufentanil 30 Mcg Tablet (Arx-04) For Moderate-To-Severe Acute Pain 3/28/2017
Pfizer (PFE) Release: XELJANZ (Tofacitinib Citrate) Receives Marketing Authorisation In The European Union For The Treatment Of Moderate To Severe Active Rheumatoid Arthritis (RA) 3/27/2017
EUSA Pharma And APEIRON Receive Positive CHMP Opinion For Dinutuximab Beta For The Treatment Of High-Risk Neuroblastoma In Europe 3/27/2017
Janssen-Cilag International NV (JNJ) Release: EPREX (Epoetin Alfa) Marketing Authorization Extended To Include Treatment Of Symptomatic Anaemia In Patients With Low Or Intermediate-1-Risk Myelodysplastic Syndromes 3/24/2017
Gamida Cell Receives Additional EMA Orphan Drug Designation For Nicord In Haematopoietic Stem Cell Transplantation (HSCT) 3/23/2017
Actinium (ATNM.OB) Announces Receipt Of Positive Scientific Advice From The EMA For Iomab-B 3/21/2017
Opthea Receives Positive Feedback From European Regulatory Agencies For The OPT-302 Clinical Program In Wet AMD 3/20/2017
AEterna Zentaris (AEZS) Announces EMA Pediatric Committee Agreement On The Pediatric Investigation Plan For Macrilen 3/7/2017
Merck & Co. (MRK), Pfizer (PFE)'s 4-Year Diabetes Alliance Pays Off With FDA, EMA Filings 3/7/2017
Merck & Co. (MRK) And Pfizer (PFE) Announce FDA And EMA Filing Acceptances Of Three Marketing Applications For Ertugliflozin-Containing Medicines For Adults With Type 2 Diabetes 3/6/2017
TiGenix Provides Update On Cx601 Marketing Authorization Application Procedure In Europe 3/6/2017
aTyr Pharma Receives EMA Orphan Drug Designation For The Treatment Of Limb Girdle Muscular Dystrophy With Resolaris 3/3/2017
Puma Biotech (PBYI) Provides Update On Review Of Marketing Authorisation Application For PB272 3/2/2017
Tesaro (TSRO) Receives Positive CHMP Opinion For VARUBY 2/27/2017
Enanta Pharmaceuticals, Inc. Announces CHMP Grants Positive Opinion For An Eight-Week Treatment Option With AbbVie (ABBV)’s VIEKIRAX(Ombitasvir/Paritaprevir/Ritonavir Tablets) + EXVIERA (Dasabuvir Tablets) For Patients With Genotype 1b Chronic Hepatitis C 2/27/2017
Shire (SHPG) Release: CHMP Recommends EU Conditional Marketing Authorisation For Natpar (Parathyroid Hormone) For Patients With Chronic Hypoparathyroidism 2/27/2017
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 Inc. (THRX) 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



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