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Zold - Clinical - MAA (World)
Pfizer Inc. (PFE) Asks EU to Approve Kidney Cancer Drug 6/1/2011
Savient Pharmaceuticals, Inc. (SVNT) Marketing Authorization Application for KRYSTEXXA® Accepted for Review by European Medicines Evaluation Agency 5/27/2011
Pharmaxis Ltd (PXS.AX) Receives Negative Bronchitol Trend Vote from CHMP; Shares Dived 70 Pct at Market Close 5/26/2011
Biogen Idec, Inc. (Massachusetts) (BIIB): European Medicines Agency’s Committee for Medicinal Products for Human Use Issues Positive Opinion on Marketing Authorization Application for FAMPYRA 5/20/2011
Acorda Therapeutics (ACOR) Statement on CHMP Positive Opinion on Marketing Authorization Application for FAMPYRA(R) in Europe 5/20/2011
Keryx Biopharmaceuticals (KERX) Receives Positive Scientific Advice from the European Medicines Evaluation Agency for Zerenex(TM) in Hyperphosphatemia 5/2/2011
Endocyte, Inc. (ECYT) Plans to Seek Early Approval for Lead Cancer Drug 4/27/2011
NicOx SA (COX.PA) Pulls Drug Application for Beprana (Naproxcinod) 4/20/2011
Novartis AG Withdraws Joicela Marketing Application in Europe 4/19/2011
Biogen Idec, Inc. (Massachusetts) (BIIB) Receives Positive Opinion from the CHMP and Authorization from Health Canada on AVONEX PEN 4/19/2011
Meda AB (MDABF.PK): Acnex Filed in Europe 4/19/2011
Octapharma AG: European Medicines Evaluation Agency Recommends to Lift the Suspension of the Marketing Authorization of octagam(R) 4/15/2011
EU Agency Backs Boehringer Ingelheim Corporation Stroke Prevention Drug 4/15/2011
Eli Lilly and Company (LLY)'s BYDUREON Recommended for Approval in Europe 4/15/2011
Allergy Therapeutics plc Submits Grass MATA MPL Dossier in Switzerland 4/7/2011
UK's NICE Doesn't Back Use Of Bristol-Myers Squibb Company (BMY)'s Orencia 3/30/2011
Omeros Corporation Announces Eligibility of OMS103HP for European Medicines Evaluation Agency Centralized Marketing Application 2/1/2011
CSL Behring Receives National Marketing Authorization of Berinert(R) in Israel 1/28/2011
Eisai Company, Ltd. (ESALY.PK) to Submit Marketing Authorization Applications in the U.S. and EU for Perampanel as Adjunctive Therapy for Partial Onset Seizures in Patients with Epilepsy 1/25/2011
MEDA Receives Positive Opinion for Retigabine in Europe 1/24/2011
EU Declines To Approve Merck KGaA (MKGAF.PK) MS Pill 1/21/2011
Novartis AG's Gilenya Multiple Sclerosis Pill Wins European Agency's Backing 1/21/2011
MEDA Positive Opinion for Retigabine in Europe 1/21/2011
InterMune, Inc. (ITMN) Announces Positive Opinion for Approval of Lung Drug Esbriet(TM) (Pirfenidone) in European Union 12/17/2010
Roche (RHHBY)'s Avastin Rejected by U.K. Agency, National Institute for Clinical Excellence (NICE) for Colorectal Cancer 12/15/2010
UK's National Institute for Clinical Excellence (NICE) Gives Rebuff To GlaxoSmithKline (GSK)'s Tykerb, Roche (RHHBY)'s Herceptin for Breast Cancer 12/15/2010
Roche (RHHBY) Drug Avastin Rejected by U.K. Agency National Institute for Clinical Excellence (NICE) for Use in Breast Cancer 12/8/2010
Allergy Therapeutics plc: Ten Further Marketing Authorization Applications Submitted in Germany 12/1/2010
Pfizer Inc. (PFE) and Protalix Biotherapeutics Announce Submission of taliglucerase alfa for European Marketing Authorization for the Treatment of Gaucher Disease 11/29/2010
Roche (RHHBY)'s Avastin Rejected by U.K. Agency for Colorectal Cancer 11/15/2010
Merck & Co., Inc. (MRK) Withdraws Bid For EU Regulatory OK Of Asthma Medicine 11/9/2010
Pharming Group (PHGUF.PK)'s Ruconest(TM) for Hereditary Angioedema(HAE) Granted European Marketing Authorization; Pharming to Receive EUR5 Million Milestone Payment from Sobi 10/28/2010
Sucampo Pharmaceuticals, Inc. Submits Marketing Application to Japanese Regulatory Authorities for Amitiza (lubiprostone) 10/7/2010
Merck KGaA (MKGAF.PK) MS Pill Cladribine Rejected by European Medicines Evaluation Agency 9/24/2010
EffRx and Nycomed Announces First European Filing for Marketing Approval of Osteoporosis Drug Targeting Increased Convenience for Patients 9/21/2010
Gilead Sciences, Inc. (GILD) Submits European Marketing Application for Once-Daily Single-Tablet Regimen of Truvada(R) and TMC278 for the Treatment of HIV Infection 9/7/2010
Gilead Sciences, Inc. (GILD) Submits European Marketing Application for Once-Daily Single-Tablet Regimen of Truvada(R) and TMC278 for the Treatment of HIV Infection 9/3/2010
Octapharma AG Release: Uniplas(R) Clinical Development Successfully Completed 8/26/2010
UK's NICE Recommends Roche Holding AG (RHHBF.PK)'s MabThera For Leukemia 7/28/2010
Sanofi-Aventis (France) (SASY.PA) And Novalar Pharmaceuticals, Inc. File Marketing Authorization Application for OraVerse(R) in Five Key European Countries 7/14/2010
Protalix Biotherapeutics Announces French ATU Granted for Taliglucerase Alfa for the Treatment of Gaucher Disease 7/13/2010
pSivida Corp (PSDV) Announces Submission of Marketing Authorization Application for an Ophthalmic Product for Diabetic Macular Edema In Certain European Union Countries 7/8/2010
Dyax Corp. (DYAX) Announces Marketing Authorization Application for DX-88 (ecallantide) Validated by European Medicines Evaluation Agency 7/6/2010
AMAG Pharmaceuticals, Inc. (AMAG) and Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Announce Acceptance of Submission of Feraheme(R) Marketing Authorization Application to the European Medicines Evaluation Agency 6/29/2010
Merck & Co., Inc. (MRK) Release: Investigational BRINAVESS(R) (vernakalant) for Infusion Recommended for Approval by the CHMP in the European Union (EU) for the Rapid Conversion of Recent Onset Atrial Fibrillation 6/28/2010
European CHMP Concludes Re-Examination Of Basilea Pharmaceutica (BSLN.SW)'s Ceftobiprole; Confirms Negative Opinion 6/25/2010
Archimedes, Inc. Receives CHMP Positive Opinion for PecFent(R) for the Treatment of Breakthrough Cancer Pain 6/25/2010
UK's NICE Rejects GlaxoSmithKline (GSK), Genmab A/S (GEN.CO) Leukemia Drug, Arzerra 6/24/2010
Santhera Pharmaceuticals AG (SANN.SW) Eyes Approval of Lead Drug, Catena in First Half of 2011 6/16/2010
New HRA Pharma "Morning-After" Pill Effective, Safe Say FDA Staff 6/15/2010
CSL Behring Announces Completion of National Marketing Authorizations of Berinert(R) After MRP in 23 European Countries 5/27/2010
Pharming Group (PHGUF.PK) Submits D180 Response for Rhucin MAA to EMA Without Clock Stop 5/25/2010
Pharming Group (PHGUF.PK) Receives D180 List of Outstanding Issues on Rhucin MAA 5/21/2010
Cell Therapeutics, Inc. (CTIC) Focuses on Pixantrone Application in Europe, U.S. Trial and Expanded Access Program; Cuts Burn Rate 4/28/2010
EU Agency Backs Nycomed's Daxas After U.S. Rebuff 4/23/2010
AstraZeneca PLC (AZN) Drug Recommended in EU for Some Depression 4/23/2010
GlaxoSmithKline (GSK) Receives Conditional Marketing Authorization in the EU for Arzerra(TM) (ofatumumab) 4/21/2010
Human Genome Sciences, Inc. (HGSI) Announces Withdrawal of European Marketing Authorization Application For JOULFERON(R) (ZALBIN) For the Treatment of Chronic Hepatitis C 4/19/2010
Merck KGaA (MKGAF.PK) Says Sees EU Statement on MS Pill in Q3 4/9/2010
Skyepharma PLC (SKYE) in Process of Filing Flutiform in EU 3/25/2010
ViroPharma Incorporated (VPHM) Announces Acceptance of Cinryze(TM) (C1 Esterase Inhibitor [Human]) Marketing Authorization Application (MAA) by European Medicines Agency (EMA) 3/24/2010
Swiss Back Two-in-one GlaxoSmithKline (GSK) Prostate Drug Duodart 3/22/2010
Roche Holding AG (RHHBF.PK) Seeks to Broaden Use of Cancer Drug MabThera 3/22/2010
OSI Pharmaceuticals, Inc. (OSIP), Roche (RHHBY) Announces That Tarceva(R) Received a Positive Opinion from Health Authorities in the European Union for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer 3/19/2010
UK, Spain Close to Approving GW Pharmaceuticals's Cannabis Drug 3/18/2010
Pharming Group (PHGUF.PK) Submits Response To Questions MAA Rhucin 3/18/2010
Mylan Inc. (MYL) Pulls EU Application for Generic Taxotere 3/15/2010
Roche Holding AG (RHHBF.PK) Cancer Drug Xeloda Gets New EU Recommendation 2/24/2010
Ark Therapeutics Files Cerepro(R) Re-Examination Documentation With The European Medicines Evaluation Agency 2/23/2010
Europe Panel Rejects Basilea Pharmaceutica's Antibiotic Ceftobiprole; Basilea Gets Back Full Drug Rights From Johnson & Johnson (JNJ) 2/19/2010
EU Agency Recommends GlaxoSmithKline (GSK) Kidney Cancer Drug 2/19/2010
United Therapeutics Corporation (UTHR) Pulls Tyvaso Drug Application in EU 2/19/2010
Provepharm Announces Acceptance Of Proveblue(R) Injectable Drug MAA For Review Under European Medicines Evaluation Agency Centralized Procedure And Validation By Novasep Of API Cgmp Process 2/12/2010
PROLOR Biotech (PBTH) Reports Merck & Co., Inc. (MRK) Receives Final Marketing Authorization in Europe for Long-Acting CTP-Modified Fertility Treatment ELONVA(R) (FSH-CTP) 1/29/2010
Pharming Group (PHGUF.PK) Gives Update on Rhucin EU Marketing Authorization Application 1/22/2010
NicOx SA (NCOX.F) Announces European Medicines Evaluation Agency Validation Of Naproxcinod MAA Submission 1/22/2010
GlaxoSmithKline (GSK) (JOBS), Genmab A/S (GEN.CO) Win EU Backing for Leukaemia Drug 1/22/2010
Pfizer Inc. (PFE) and Auxilium Pharmaceuticals (AUXL) Announce Commencement of European Regulatory Review of XIAFLEXTM for the Treatment of Dupuytren's Contracture 1/21/2010
BioSpecifics Technologies Corporation (BSTC) Announces Commencement of European Regulatory Review of XIAFLEX(TM) for the Treatment of Dupuytren's Disease 1/21/2010
Novartis Corporation (NVS) Edges Ahead of Merck KGaA (MKGAF.PK) in MS Race; Novartis's Lower Dose of FTY720 Filed for U.S. and EU Approval; Merck's Cladribine Faces FDA Delay 1/21/2010
Ark Therapeutics Files For Re-Examination Of Cerepro 1/5/2010
NicOx SA (NCOX.F) Submits Naproxcinod MAA to the FDA 12/22/2009
European Medicines Evaluation Agency Negative Recommendation on Ark Therapeutics' Cerepro 12/18/2009
Pfizer Inc. (PFE) (JOBS) Receives European Authorization For Prevenar 13* For The Prevention Of Pneumococcal Disease In Infants And Young Children 12/11/2009
ChemGenex Pharmaceuticals Limited (CXS.AX)'s Marketing Authorization Application for Omacetaxine Mepesuccinate Validated by the European Medicines Evaluation Agency 11/30/2009
Theravance, Inc. (THRX) Announces That European Medicines Evaluation Agency Has Completed the Validation Phase for the Telavancin MAA for the Treatment of Nosocomial Pneumonia and Complicated Skin and Soft Tissue Infections 11/30/2009
Shire plc Submits European Marketing Authorization Application (MAA) for velaglucerase alfa for the Treatment of Type 1 Gaucher Disease 11/24/2009
Antigenics Inc. (New York) (AGEN) Cancer Vaccine Gets Negative EU Panel Vote 11/20/2009
Recordati S.p.A: European Medicines Evaluation Agency Adopts A Positive Opinion For Silodosin (Brands Urorec(R) And Silodyx(R)) 11/20/2009
Antigenics Inc. (Lexington, MA) (AGEN) Kidney Cancer Vaccine Oncophage Rejected In Europe 10/21/2009
Pharming Group (PHGUF.PK)'s Marketing Authorisation Application for Rhucin Validated by the European Medicines Evaluation Agency 9/24/2009
Gilead Sciences, Inc. (GILD): European Commission Grants Conditional Marketing Authorization to Cayston(R) (Aztreonam Lysine) for the Treatment of Chronic Pulmonary Infections Due to Pseudomonas Aeruginosa in Patients with Cystic Fibrosis 9/23/2009
Pharming Group (PHGUF.PK) Submits Marketing Authorisation Application For Rhucin(R) To The European Medicines Evaluation Agency 9/3/2009
Lumavita AG Announces Marketing Authorisation for Pentamycin in Switzerland 8/27/2009
BioAlliance Pharma: Loramyc(R) Obtains Marketing Authorization in Switzerland 8/24/2009
Cangene Corporation (CC:CNJ) Opts to Exit European Market with WinRho(R) SDF 7/31/2009
MediGene AG (DX:MDG) Receives Positive Assessment on Market Authorisation for Veregen(R) in First European Countries 7/10/2009
Novo Nordisk A/S (NVO)'s Victoza(R) (liraglutide) Receives Marketing Authorisation in Europe 7/6/2009
Bristol-Myers Squibb Company (BMY)'s ONGLYZA(TM) (Saxagliptin) Receives Positive Opinion in Europe for the Treatment of Type 2 Diabetes 6/25/2009
Centocor Ortho Biotech Inc.: Two-Year Data Show Patients Receiving SIMPONI(TM) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis 6/10/2009
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) to Delay European Application for Key Drug 6/5/2009
BioPartners GmbH Withdraws Application for Marketing Authorisation for Biferonex 5/29/2009
Basilea Pharmaceutica's Toctino(R) Receives Marketing Authorization in Netherlands 4/29/2009
Amarin Corporation PLC (AMRN)'s Marketing Authorization Application for AMR101 to Treat Huntington’s Disease Accepted for Review by European Medicines Evaluation Agency 4/8/2009
Pharming Group (PHGUF.PK) Confirms Rhucin European MAA Filing Timeline 3/31/2009
Lumavita AG Announces Receipt of Preliminary Approval for Marketing Authorisation of Pentamycin 3/24/2009
Basilea Pharmaceutica's Toctino(R) Receives Marketing Authorization in Belgium and Luxemburg 3/11/2009
BioAlliance Pharma Files for European Marketing Authorization for Ondansetron RapidFilm(TM) in Supportive Care in Cancer 2/17/2009
GlaxoSmithKline (GSK) and Genmab A/S (GNMSF.PK) Seek European Marketing Authorization of Arzerra (Ofatumumab) in Advanced Stage Blood Cancer 2/6/2009
Roche (RHHBY)'s Mabthera Seeks Approval In The EU For Treatment In Most Common Form Of Leukaemia In Adults 1/28/2009
Ark Therapeutics files Cerepro(R) Application for Marketing Authorisation with European Medicines Evaluation Agency 12/1/2008
Recordati S.p.A Submits File For Approval Of Silodosin To The European Medicines Evaluation Agency 11/21/2008
European Medicines Evaluation Agency Issues Positive Opinion For LUNIVIA(R) (Eszopiclone) Marketing Authorization Application (MAA) In Europe 10/24/2008
Medivir AB (MVIRb.F): Marketing Authorization Application for Lipsovir(R) Submitted to European Regulatory Authorities 10/23/2008
Basilea Pharmaceutica's Toctino(R) (alitretinoin) Receives Marketing Authorization in France 10/21/2008
Basilea Pharmaceutica's Toctino(R) (alitretinoin) Receives Marketing Authorization in Finland 10/15/2008
Celgene Corporation (CELG) Release: Oral Cancer Drug REVLIMID(R) Receives Marketing Authorization from Health Canada for Treatment of Multiple Myeloma 10/6/2008
Basilea Pharmaceutica's Toctino(R) (alitretinoin) Receives Marketing Authorization in Germany 10/6/2008
Pharmaxis Ltd (PXS.AX) Files First Marketing Application for Bronchitol in Australia 10/1/2008
Teva Pharmaceutical Industries Limited (TEVA) Receives EU Marketing Authorization for TevaGrastim(R) 9/16/2008
Bristol-Myers Squibb Company (BMY) (JOBS) Welcomes NICE Guidance Recommending Baraclude(R) (entecavir) as a Treatment Option for Chronic Hepatitis B 8/29/2008
Arpida, Inc.'s iclaprim MAA Accepted for Review by European Medicines Evaluation Agency 8/21/2008
Celgene (CELG) Subsidiary Pharmion Corporation (PHRM) Withdraws European Marketing Application for Orplatna 8/14/2008
European Commission Grants Marketing Authorization for MediGene AG (DX:MDG)'s Drug Oracea 7/29/2008
GPC Biotech AG (GPCG.DE) Withdraws European Prostate Drug Filing 7/28/2008
Arpida Submits Marketing Authorisation Application for Intravenous Iclaprim in Europe 7/28/2008