News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    

Zold - Clinical - BLA/NDA/ANDA (World)
EMA Acknowledges Clinuvel’s Novel Drug Filing in Europe in 2011 5/12/2011
Roche (RHHBY) Seeks Approvals for New Skin Cancer Drug 5/11/2011
First EffRx NDA Accepted for Filing by the FDA 5/11/2011
Simcere Pharmaceutical Group Announces Recent Progress of Qiangke's Registration 5/9/2011
Novartis AG Aims to Resurrect ‘Zombie’ Drug After Four Years 4/6/2011
Teva Pharmaceutical Industries Limited (TEVA) Receives Positive Opinion for NOMAC/E2 from the European Committee for Medicinal Products 3/18/2011
European Regulators Slap Amgen (AMGN) with Negative Opinion; To Review CHMP Opinion On Vectibix Use With Chemotherapy 3/18/2011
UCB, Inc. (UCBJF.PK)'s Xyrem Rejected in EU for Fibromyalgia 3/18/2011
UK's NICE Backs Merck & Co., Inc. (MRK)'s Rheumatoid Arthritis Drug Simponi 3/17/2011
Zeltia Group (18494051.MA) Fails to Win U.K. Backing for Ovarian Cancer Drug 3/11/2011
FDA Accepts Lundbeck Inc.'s Submission Of NDA For Clobazam 3/4/2011
Sinovac Biotech Ltd. (SNVBF) Submits Clinical Trial Application to SFDA for Pneumococcal Conjugate Vaccine (PCV) 3/3/2011
FDA Grants QRxPharma Pty Ltd. Pre-New Drug Application Meeting in March 2011 2/22/2011
Merck KGaA (MKGAF.PK) Withdraws Filing for Oral MS Drug in Europe 2/18/2011
Astellas Pharma Inc. (YPH.BE) Withdraws Japan Filing for Darexaban, Looks for Partners 2/16/2011
FDA Denies GlaxoSmithKline (GSK) Expanded Avodart OK for Now 1/27/2011
Biogen Idec, Inc. (Massachusetts) (BIIB) Receives Negative Opinion from the CHMP on FAMPYRA 1/21/2011
Bayer AG (BAY.F) Seeks EU Approval for New Blood Thinner, Rivaroxaban 1/5/2011
Santarus Inc. (SNTS) and Pharming Group (PHGUF.PK) Announce Submission of RHUCIN Biologics License Application to FDA 12/28/2010
Teva Pharmaceutical Industries Limited (TEVA) Release: FDA Issues Complete Response Letter for Lower-Volume Glatiramer Acetate sNDA 12/27/2010
Affymax, Inc. (AFFY) and Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Confirm U.S. Registration Strategy for Investigational Drug, Hematide(TM)/Peginesatide, Following Meeting with FDA 11/29/2010
Sun Pharmaceutical Industries Ltd Announces US FDA Tentative Approval for Generic Cymbalta(R) 11/24/2010
Roche (RHHBY)'s Avastin Rejected by U.K. Agency for Colorectal Cancer 11/15/2010
EUSA Pharma Submits ERWINASE(R) Biologics License Application (BLA) for Treatment of Acute Lymphoblastic Leukemia 11/9/2010
AstraZeneca PLC (AZN)'s Nasal Flu Vaccine, Fluenz Gets European Medicines Evaluation Agency's Backing For Kids 10/22/2010
EU Backs AstraZeneca PLC (AZN) and Pozen, Inc. (POZN)'s Arthritis Pill, Vimovo 10/11/2010
ChemGenex Pharmaceuticals Limited (CXS.AX) Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for OMAPROTM 10/5/2010
Teva Pharmaceutical Industries Limited (TEVA) Provides Update on Status of Neutroval(TM) (G-CSF) Biologics License Application Submitted to the U.S. FDA 9/30/2010
Sun Pharmaceutical Industries Ltd Announces FDA Tentative Approval for Generic Rilutek(R) 9/28/2010
Celgene (CELG) Seeks To Stop Natco Pharma Limited's Generic Revlimid; Officially Notified of ANDA Filing Today 9/3/2010
Pharming Group (PHGUF.PK) Plans Submission Rhucin BLA to US FDA end 2010 8/25/2010
UK's National Institute for Clinical Excellence (NICE) Rejects Novartis Corporation (NVS)'s Xolair Again In Kids Aged 6 To 11 8/13/2010
Teva Pharmaceutical Industries Limited (TEVA) Comments on Generic Lovenox(R) Approval 7/23/2010
NicOx SA (COX.PA) Says Key Drug, Naproxcinod Rejected by FDA 7/23/2010
ChemGenex Pharmaceuticals Limited (CXS.AX) and U.S. FDA Agree on Potential Regulatory Pathway for OMAPRO(TM) 7/14/2010
Bristol-Myers Squibb Company (BMY) And Otsuka Pharmaceutical Co., Ltd. Release: SPRYCEL(R) (dasatinib) Receives FDA Priority Review for the Treatment of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia (CML) in Chronic Phase 7/12/2010
Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Mepact Rejected by UK's National Institute for Clinical Excellence (NICE) on Bone Cancer Survival 7/9/2010
UK's National Institute for Clinical Excellence (NICE) Rejects Roche (RHHBY)'s Avastin In Breast Cancer 7/9/2010
Merck & Co., Inc. (MRK), Cardiome Pharma Corp. (COM.TO) Heart Drug Gets Positive EU Review 6/25/2010
Pharming Group (PHGUF.PK) Receives Positive Opinion From European Medicines Evaluation Agency On Rhucin 6/24/2010
Boehringer Ingelheim Pharmaceuticals, Inc. Comments on June 18th FDA Advisory Committee Meeting 6/21/2010
Roche (RHHBY), Ipsen Drug Faces at Least 12-18 Month Delay 6/21/2010
FDA Panel Votes Against NDA For Boehringer Ingelheim Corporation's 'Female Viagra' Flibanserin 6/21/2010
Phytopharm PLC (PYM.L) Receives USA Regulatory Approval To Begin Phase II Clinical Trial Of Cogane(TM) 6/14/2010
Merck KGaA (MKGAF.PK) Again Seeks U.S. Nod for Cladribine MS Pill 6/8/2010
Teva Pharmaceutical Industries Limited (TEVA) Announces Tentative Approval of Generic Sensipar(R) 5/14/2010
Protalix Biotherapeutics Submits Validation Data on Manufacturing Process to FDA 4/27/2010
ChemGenex Pharmaceuticals Limited (CXS.AX) Receives a Complete Response Letter from the FDA for OMAPRO(TM) 4/12/2010
Sun Pharmaceutical Industries Ltd Announces US FDA Tentative Approval for Generic Namenda(R) Tablets 4/12/2010
Daiichi Sankyo, Inc. Submits First New Drug Application for Oral Factor Xa Inhibitor, Edoxaban Innovative Once-Daily Oral Factor Xa Inhibitor Submitted for Approval in Japan 4/6/2010
GlaxoSmithKline (GSK) Regulatory Update - Avodart (dutasteride) 3/30/2010
Sanofi-Aventis (France) (SASY.PA): Multaq(R) Receives Positive Recommendation by NICE in New Appraisal Consultation Document 3/30/2010
Teva Pharmaceutical Industries Limited (TEVA) Announces Tentative Approval of Generic Argatroban(R) Injection 3/25/2010
Ark Therapeutics Pulls Drug Application, Weighs Sale of Company 3/9/2010
U.S. FDA Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review ChemGenex Pharmaceuticals Limited (CXS.AX)'s OMAPRO(TM) 3/2/2010
Hovione's TwinCaps(R) Dry-Powder Inhaler Filed in Japan for the Treatment of Influenza 2/2/2010
Teva Pharmaceutical Industries Limited (TEVA) Announces FDA Accepts BLA for XM02 2/2/2010
Protalix Biotherapeutics Says FDA Seeks More Data on Gaucher Drug 2/2/2010
Novo Nordisk A/S (NVO) Awaits China Approval of Type 2 Diabetes Treatment 1/29/2010
FDA Issues Complete Response Letter for Warner Chilcott Low Dose Oral Contraceptive 1/28/2010
Skyepharma PLC (SKYE) – Flutiform(TM) U.S. NDA Update; FDA Denies Approval For Now, Needs Additional Data 1/21/2010
Eisai Company, Ltd. (ESALY.PK) Submits Application for Additional Indication of Anti-arrhythmic Agent Tambocor(R) Tablets for Tachyarrhythmia in Paediatric Patients in Japan 1/14/2010
3SBio Inc. (SSRX) Applies for SFDA Registrational Trial for Feraheme(TM) 1/8/2010
PhotoCure Received Positive Response From FDA on the New Drug Application (NDA) for Hexvix(R) for Detection of Bladder Cancer 1/4/2010
Meda AB (SE:MEDAa): FDA Accepts NDA filing for Retigabine 12/30/2009
Eisai Company, Ltd. (ESALY.PK) Release: Submission of a New Drug Application for Pancreatic Enzyme Replacement Therapy Agent SA-001 in Japan 12/28/2009
Sinovac Beijing Files Clinical Trial Application with SFDA for Vaccine Against Hand, Foot, and Mouth Disease 12/28/2009
European Panel Recommends Amgen (AMGN) (JOBS), GlaxoSmithKline (GSK) (JOBS) Bone Drug 12/18/2009
ChemGenics Pharmaceuticals Announces Omapro(TM) to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation 12/17/2009
FDA Advisory Committee Voted Favourably to PhotoCure's New Drug Application in USA for Hexvix 12/17/2009
Basilea Pharmaceutica's Toctino(R) Recommended For Approval In 15 Additional European Countries 12/14/2009
Pharming Group (PHGUF.PK) Confirms Interaction With US FDA for Rhucin 12/9/2009
Protalix Biotherapeutics Completes NDA Submission for Taliglucerase Alfa for the Treatment of Gaucher's Disease 12/9/2009
Janssen-Cilag AG Submits Marketing Authorisation Application in Europe for Paliperidone Palmitate for the Treatment of Schizophrenia 12/4/2009
Teva Pharmaceutical Industries Limited (TEVA) Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia 12/1/2009
Bavarian Nordic (BAVA.CO) Will File for Market Approval for IMVAMUNE(R) in Canada 11/30/2009
Stallergenes, S.A. (GENP.PA) is Granted a Marketing Authorization for Oralair(R) in Europe 11/30/2009
PROLOR Biotech (PBTH) Reports Merck & Co., Inc. (MRK) Receives Positive Regulatory Opinion for European Marketing of Long-Acting CTP-Modified Fertility Treatment ELONVA(R) (FSH-CTP) 11/24/2009
Genzyme Corporation (GENZ) Rival Seeks European Approval 11/24/2009
Astellas Pharma Inc. and XenoPort, Inc. (XNPT) Announce Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome 11/19/2009
NicOx SA (NCOX.F) Announces FDA Accepts Naproxcinod NDA For Filing 11/18/2009
MEDA: Retigabine Filings Completed in the US and Europe 11/2/2009
US FDA Delays Approval of Amgen (AMGN) (JOBS) Osteoporosis Drug 10/20/2009
Merck KGaA (MKGAF.PK) Seeks FDA Approval for First MS Pill 9/30/2009
Abbott Laboratories (ABT) and Eisai Company, Ltd. (ESALY.PK) Submit Application for Approval of Humira(R) for the Treatment of Crohn's Disease in Japan 9/30/2009
Eisai Company, Ltd. (ESALY.PK) Submits Application for Additional Indication of its Proton Pump Inhibitor PARIET(R) for Non-erosive GERD in Japan 9/29/2009
Sanofi-Aventis (France) (SASY.PA)'s Multaq(R) Recommended for Approval in the European Union 9/28/2009
NicOx SA (NCOX.F) Submits New Drug Application (NDA) for Naproxcinod to the US FDA 9/25/2009
Sanofi-Aventis (France) (SASY.PA): Multaq(R) (dronedarone) Recommended for Approval in the European Union 9/25/2009
Novo Nordisk A/S (NVO) Says FDA Feedback on Victoza Delayed 9/23/2009
UK's NICE Again Rejects Bayer Corporation (BAY) (JOBS) Liver Cancer Drug 9/9/2009
China Sky One Medical, Inc. Submits Application to Perform Clinical Trials for Two New Eye Drugs to SFDA 9/3/2009
Sinovac Biotech Ltd. (SNVBF): China Set to Approve 1-Dose Swine Flu Vaccines 9/2/2009
The Medicines Company (MDCO) (JOBS) Withdraws European Application for Drug 8/24/2009
Teva Pharmaceutical Industries Limited (TEVA) Announces Approval and Launch of Oxaliplatin Injection; New NDA 8/12/2009
AstraZeneca PLC (AZN) (JOBS) Still Awaiting FDA News on Onglyza 8/3/2009
Watchdog Delays UK Debut Of AstraZeneca PLC (AZN) (JOBS) Swine Flu Treatment 7/30/2009
GlaxoSmithKline (GSK) (JOBS) Pulls EU Application For Rare Disease Drug 7/30/2009
Novartis Pharma AG (NVS) (JOBS) Obtains EU Positive Opinion For New Biologic Drug 7/29/2009
Merck KGaA (MKGAF.PK) Falls; EU Rejects Erbitux for Lung Cancer 7/27/2009
Mesoblast Limited Applies For Regulatory Approval Of Its Bone Fracture Repair Products 7/23/2009
FDA Extends Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s (JOBS) Alogliptin-Actos Drug Review 7/23/2009
Nycomed Announces FDA Filing for Daxas(R) in COPD 7/20/2009
Protalix Biotherapeutics Holds Pre-NDA Meeting with FDA for prGCD 7/14/2009
Eisai Corporation of North America and Pfizer Inc. (PFE) Decide not to Appeal NICE Decision and Call for an Expedited Review of Guidance for Alzheimer's Disease 7/1/2009
Lundbeck Inc. (formerly Ovation Pharmaceuticals) Shares Drop as Drug Hits FDA Snag 6/29/2009
Positive CHMP Opinion for Laboratoires Pierre Fabre's JAVLOR(R) in Metastatic Treatment of Bladder Cancer After Failure of a Prior Platinum-Containing Regimen 6/26/2009
EU Agency Backs New Centocor Ortho Biotech Inc., Schering-Plough Corporation (SGP) (JOBS) Arthritis Drug 6/26/2009
BioAlliance Pharma Submits Loramyc(R) NDA to US FDA 6/15/2009
SkyePharma Inc. (SKYE) Says FDA May Need More Flutiform Data 6/10/2009
AstraZeneca PLC (AZN) (JOBS) , Abbott Laboratories (ABT) (JOBS) File 2-in-1 Cholesterol Drug 6/5/2009
Pharmaxis Ltd (PXS.AX) Release: U.S. FDA Accepts Aridol(TM) New Drug Application for Review 5/14/2009
BioAlliance Pharma to Resubmit Loramyc(R) NDA in the Second Quarter of 2009 5/7/2009
Sanofi-Aventis (France) (SASY.PA) Expects FDA Letter on Heart Drug in Q2 5/5/2009
Genmab A/S (GNMSF.PK) Release: FDA Advisory Committee to Review Arzerra(TM) (Ofatumumab) 5/4/2009
Novo Nordisk A/S (NVO) in Constructive Dialogue with FDA on Victoza 4/24/2009
BioAlliance Pharma To Complete NDA For Loramyc(R) With Data on Debossed Mucoadhesive Tablet 4/9/2009
Bristol-Myers Squibb Company (BMY), AstraZeneca PLC (AZN) ONGLYZA (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee; Rival to Merck & Co., Inc. (MRK)'s Januvia Moves Closer to Approval 4/2/2009
GlaxoSmithKline (GSK) Submits TYVERB(R)/TYKERB(R) (lapatinib) for First-Line Treatment of Metastatic Breast Cancer in Europe, US 4/1/2009
GlaxoSmithKline (GSK) Release: CERVARIX(R) U.S. Regulatory Update 3/30/2009
Novo Nordisk A/S (NVO), AstraZeneca PLC (AZN)-Bristol-Myers Squibb Company (BMY) Diabetes Drugs Face U.S. Grilling 3/26/2009
Bayer AG (BAY.F) Shares Jump on Recommendation for Xarelto 3/20/2009
FDA Advisory Committee Recommends Approval of Sanofi-Aventis (France) (SASY.PA)'s Multaq(R) (dronedarone) 3/19/2009
OSI Pharmaceuticals, Inc. (OSIP) Submits Supplemental New Drug Application to the FDA for Tarceva as a First-Line Maintenance Therapy in Advanced Non-Small Cell Lung Cancer 3/19/2009
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Shares Plunge on Drug Delay Worries 3/9/2009
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Says FDA Needs More Data on Key Diabetes Drug 3/6/2009
US Regulators Need More Info on Actelion Ltd. (ALIOF.PK) Drug 3/2/2009
Pharmaxis Ltd (PXS.AX) Announces New Drug Application Submission for Aridol(TM) 3/2/2009
Janssen-Cilag AG Announces CHMP Delays European Commission Decision Process to Approve ZEVTERATM 2/24/2009
Basilea Pharmaceutica Announces Zevtera(TM) Review Process Delayed in EU 2/24/2009
Merck & Co., Inc. (MRK) (JOBS) Pulls Bid for EU Approval of Zolinza 2/17/2009
The French Biopharmaceutical Group LFB S.A. Has Announced the First-in-Man Injections of Its First Two Therapeutic Monoclonal Antibodies and the Filing of BLAs for a New-Generation Immunoglobulin and a Fibrinogen 2/10/2009
UCB, Inc. (UCBJF.PK)'s Meeting With U.S. FDA Defines Path Forward for Cimzia(R) in Rheumatoid Arthritis 2/6/2009
FDA Has Approved Zealand Pharma's Investigative New Drug Application (IND) For ZP1848 To Be Administered In Humans. ZP1848 Is Developed For The Prevention And Treatment Of Crohn's Disease 2/3/2009
GlaxoSmithKline (GSK) and Genmab A/S (GNMSF.PK) Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer 1/30/2009
Roche (RHHBY)'s MabThera Receives Positive Opinion in Europe for First-line Treatment for Chronic Lymphocytic Leukaemia 1/23/2009
IntelGenx Corp. and Circ Pharma Ltd Announced Today a Partnership to Develop and Commercialise a Novel Drug for the Treatment of Hyperlipidemia 1/20/2009
Q-Med AB Has Obtained Registration Approval for Restylane(R) in China 1/7/2009
Nitec Pharma AG's New Rheumatoid Arthritis Treatment, Lodotra, Recommended For European Regulatory Approval 1/7/2009
Ark Therapeutics Says Gene Drug Cerepro Accepted by EU 1/6/2009
UCB, Inc. (UCBJF.PK) Receives Complete Response Letter From U.S. FDA for Use of Cimzia(R) in Rheumatoid Arthritis Patients 1/5/2009
US FDA Advisers to Review Eli Lilly and Company (LLY), Daiichi Sankyo Co Ltd. Clot Drug 1/2/2009
Intercell AG Sees U.S. JE Vaccine Approval in Early 2009 12/29/2008
AstraZeneca PLC (AZN) Says FDA Requests Seroquel Information 12/29/2008
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Says US FDA to Respond on Diabetes Drug by June 12/29/2008
Ipsen Release: FDA Issues Complete Response Letter to Ipsen for Dysport(R) Biologics License Application 12/29/2008
Teva Pharmaceutical Industries Limited (TEVA) Announces Tentative Approval of Generic Seroquel(R) Tablets 12/29/2008
UCB Group (UCBJF.PK) Receives U.S. FDA Complete Response Letter for Neupro(R) in Restless Legs Syndrome and Advanced Parkinson's Disease 12/19/2008
Intercell AG Receives CHMP Positive Opinion for the Approval of IXIARO® in Europe – Vaccine Against Japanese Encephalitis 12/15/2008
Sanofi-Aventis (France) (SASY.PA)'s Multaq to get U.S. Panel Review in March 12/1/2008
Novartis AG (JOBS) to Combine Heart Pills as Afinitor Cancer Drug Delayed 11/20/2008
Novo Nordisk A/S (NVO) - Research Update 11/18/2008
Watson Pharmaceuticals, Inc. (WPI) Release: Debiopharm Announces U.S. NDA Filing of Trelstar(R) 6-Month Formulation for Locally Advanced or Metastatic Prostate Cancer 11/14/2008
3SBio Inc. (SSRX) Files for SFDA Approval of NuLeusin 11/10/2008
Merck KGaA (MKGAF.PK)'s Erbitux Gets Green Light for Head Cancer 10/24/2008
Meda AB (SE:MEDAa):FDA Has Accepted for Filing the First Potential Once-a-Day Nasal Antihistamine 10/24/2008
Intercell AG Making Strides Towards Imminent Approval Of Its Japanese Encephalitis Vaccine In The United States 10/21/2008
UK's NICE Turns Down GlaxoSmithKline (GSK)'s Tyverb Offer 10/14/2008
Sanofi-Aventis (France) (SASY.PA), Daiichi Sankyo Co Ltd. Delay Japan's First Imported Vaccine 10/1/2008
Medivir AB (MVIRb.F): New Drug Application (NDA) for Lipsovir(R) Submitted to US FDA 10/1/2008
Ipsen: FDA's First-Cycle Review of Dysport(R) to Be Completed by Year-End 9/30/2008
Eli Lilly and Company (LLY)'s (JOBS), Daiichi Sankyo Co Ltd. Prasugrel Delayed as U.S. Continues Review 9/29/2008
Ipsen Announces the Filing of Decapeptyl(R) 6-month Formulation for the Treatment of Locally Advanced or Metastatic Prostate Cancer in Europe 9/25/2008
UCB Group (UCBJF.PK) Withdraws EU Marketing Authorisation Application for Lacosamide in Diabetic Neuropathic Pain 9/25/2008
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Submits a New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes 9/24/2008
Lundbeck Files for U.S. Approval for Serdolect 9/15/2008
Basilea Pharmaceutica Release: FDA Accepts for Review the Complete Response to Ceftobiprole NDA Approvable Letter 9/15/2008
Meda AB (SE:MEDAa): Anticipated Approval Of Onsolis(TM) During First Half 2009 Following Receipt of Complete Response Letter from FDA 8/28/2008
UK's NICE Recommends Novartis Pharmaceuticals UK Limited (NVS) Eye Drug Lucentis 8/27/2008
Meda AB (SE:MEDAa): Registration Application for Azelastine Extra Strength Submitted to the FDA 8/4/2008
Regulatory Approval of Basilea Pharmaceutica's Toctino(R) (alitretinoin) Recommended by Concerned EU Member States 7/31/2008
Bristol-Myers Squibb Company (BMY) and AstraZeneca PLC (AZN) Submit New Drug Application in the United States and Marketing Authorization Application in Europe for ONGLYZA(TM) for the Treatment of Type 2 Diabetes 7/23/2008
U.K. Medicines Advisory Group Rejects GlaxoSmithKline (GSK)'s (JOBS) Tyverb 7/8/2008



//-->