Hovione's TwinCaps(R) Dry-Powder Inhaler Filed in Japan for the Treatment of Influenza
2/2/2010
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Teva Pharmaceutical Industries Limited (TEVA) Announces FDA Accepts BLA for XM02
2/2/2010
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Protalix Biotherapeutics Says FDA Seeks More Data on Gaucher Drug
2/2/2010
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Novo Nordisk A/S (NVO) Awaits China Approval of Type 2 Diabetes Treatment
1/29/2010
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FDA Issues Complete Response Letter for Warner Chilcott Low Dose Oral Contraceptive
1/28/2010
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Skyepharma PLC (SKYE) – Flutiform(TM) U.S. NDA Update; FDA Denies Approval For Now, Needs Additional Data
1/21/2010
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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
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3SBio Inc. (SSRX) Applies for SFDA Registrational Trial for Feraheme(TM)
1/8/2010
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PhotoCure Received Positive Response From FDA on the New Drug Application (NDA) for Hexvix(R) for Detection of Bladder Cancer
1/4/2010
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Meda AB (SE:MEDAa): FDA Accepts NDA filing for Retigabine
12/30/2009
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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
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Sinovac Beijing Files Clinical Trial Application with SFDA for Vaccine Against Hand, Foot, and Mouth Disease
12/28/2009
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European Panel Recommends Amgen (AMGN) (JOBS), GlaxoSmithKline (GSK) (JOBS) Bone Drug
12/18/2009
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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
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FDA Advisory Committee Voted Favourably to PhotoCure's New Drug Application in USA for Hexvix
12/17/2009
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Basilea Pharmaceutica's Toctino(R) Recommended For Approval In 15 Additional European Countries
12/14/2009
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Pharming Group (PHGUF.PK) Confirms Interaction With US FDA for Rhucin
12/9/2009
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Protalix Biotherapeutics Completes NDA Submission for Taliglucerase Alfa for the Treatment of Gaucher's Disease
12/9/2009
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Janssen-Cilag AG Submits Marketing Authorisation Application in Europe for Paliperidone Palmitate for the Treatment of Schizophrenia
12/4/2009
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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
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Bavarian Nordic (BAVA.CO) Will File for Market Approval for IMVAMUNE(R) in Canada
11/30/2009
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Stallergenes, S.A. (GENP.PA) is Granted a Marketing Authorization for Oralair(R) in Europe
11/30/2009
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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
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Genzyme Corporation (GENZ) Rival Seeks European Approval
11/24/2009
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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
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NicOx SA (NCOX.F) Announces FDA Accepts Naproxcinod NDA For Filing
11/18/2009
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MEDA: Retigabine Filings Completed in the US and Europe
11/2/2009
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US FDA Delays Approval of Amgen (AMGN) (JOBS) Osteoporosis Drug
10/20/2009
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Merck KGaA (MKGAF.PK) Seeks FDA Approval for First MS Pill
9/30/2009
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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
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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
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Sanofi-Aventis (France) (SASY.PA)'s Multaq(R) Recommended for Approval in the European Union
9/28/2009
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NicOx SA (NCOX.F) Submits New Drug Application (NDA) for Naproxcinod to the US FDA
9/25/2009
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Sanofi-Aventis (France) (SASY.PA): Multaq(R) (dronedarone) Recommended for Approval in the European Union
9/25/2009
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Novo Nordisk A/S (NVO) Says FDA Feedback on Victoza Delayed
9/23/2009
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UK's NICE Again Rejects Bayer Corporation (BAY) (JOBS) Liver Cancer Drug
9/9/2009
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China Sky One Medical, Inc. Submits Application to Perform Clinical Trials for Two New Eye Drugs to SFDA
9/3/2009
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Sinovac Biotech Ltd. (SNVBF): China Set to Approve 1-Dose Swine Flu Vaccines
9/2/2009
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The Medicines Company (MDCO) (JOBS) Withdraws European Application for Drug
8/24/2009
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Teva Pharmaceutical Industries Limited (TEVA) Announces Approval and Launch of Oxaliplatin Injection; New NDA
8/12/2009
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AstraZeneca PLC (AZN) (JOBS) Still Awaiting FDA News on Onglyza
8/3/2009
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Watchdog Delays UK Debut Of AstraZeneca PLC (AZN) (JOBS) Swine Flu Treatment
7/30/2009
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GlaxoSmithKline (GSK) (JOBS) Pulls EU Application For Rare Disease Drug
7/30/2009
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Novartis Pharma AG (NVS) (JOBS) Obtains EU Positive Opinion For New Biologic Drug
7/29/2009
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Merck KGaA (MKGAF.PK) Falls; EU Rejects Erbitux for Lung Cancer
7/27/2009
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Mesoblast Limited Applies For Regulatory Approval Of Its Bone Fracture Repair Products
7/23/2009
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FDA Extends Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s (JOBS) Alogliptin-Actos Drug Review
7/23/2009
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Nycomed Announces FDA Filing for Daxas(R) in COPD
7/20/2009
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Protalix Biotherapeutics Holds Pre-NDA Meeting with FDA for prGCD
7/14/2009
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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
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Lundbeck Inc. (formerly Ovation Pharmaceuticals) Shares Drop as Drug Hits FDA Snag
6/29/2009
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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
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EU Agency Backs New Centocor Ortho Biotech Inc., Schering-Plough Corporation (SGP) (JOBS) Arthritis Drug
6/26/2009
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BioAlliance Pharma Submits Loramyc(R) NDA to US FDA
6/15/2009
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SkyePharma Inc. (SKYE) Says FDA May Need More Flutiform Data
6/10/2009
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AstraZeneca PLC (AZN) (JOBS) , Abbott Laboratories (ABT) (JOBS) File 2-in-1 Cholesterol Drug
6/5/2009
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Pharmaxis Ltd (PXS.AX) Release: U.S. FDA Accepts Aridol(TM) New Drug Application for Review
5/14/2009
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BioAlliance Pharma to Resubmit Loramyc(R) NDA in the Second Quarter of 2009
5/7/2009
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Sanofi-Aventis (France) (SASY.PA) Expects FDA Letter on Heart Drug in Q2
5/5/2009
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Genmab A/S (GNMSF.PK) Release: FDA Advisory Committee to Review Arzerra(TM) (Ofatumumab)
5/4/2009
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Novo Nordisk A/S (NVO) in Constructive Dialogue with FDA on Victoza
4/24/2009
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BioAlliance Pharma To Complete NDA For Loramyc(R) With Data on Debossed Mucoadhesive Tablet
4/9/2009
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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
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GlaxoSmithKline (GSK) Submits TYVERB(R)/TYKERB(R) (lapatinib) for First-Line Treatment of Metastatic Breast Cancer in Europe, US
4/1/2009
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GlaxoSmithKline (GSK) Release: CERVARIX(R) U.S. Regulatory Update
3/30/2009
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Novo Nordisk A/S (NVO), AstraZeneca PLC (AZN)-Bristol-Myers Squibb Company (BMY) Diabetes Drugs Face U.S. Grilling
3/26/2009
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Bayer AG (BAY.F) Shares Jump on Recommendation for Xarelto
3/20/2009
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FDA Advisory Committee Recommends Approval of Sanofi-Aventis (France) (SASY.PA)'s Multaq(R) (dronedarone)
3/19/2009
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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
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Shares Plunge on Drug Delay Worries
3/9/2009
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Says FDA Needs More Data on Key Diabetes Drug
3/6/2009
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US Regulators Need More Info on Actelion Ltd. (ALIOF.PK) Drug
3/2/2009
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Pharmaxis Ltd (PXS.AX) Announces New Drug Application Submission for Aridol(TM)
3/2/2009
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Janssen-Cilag AG Announces CHMP Delays European Commission Decision Process to Approve ZEVTERATM
2/24/2009
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Basilea Pharmaceutica Announces Zevtera(TM) Review Process Delayed in EU
2/24/2009
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Merck & Co., Inc. (MRK) (JOBS) Pulls Bid for EU Approval of Zolinza
2/17/2009
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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
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UCB, Inc. (UCBJF.PK)'s Meeting With U.S. FDA Defines Path Forward for Cimzia(R) in Rheumatoid Arthritis
2/6/2009
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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
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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
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Roche (RHHBY)'s MabThera Receives Positive Opinion in Europe for First-line Treatment for Chronic Lymphocytic Leukaemia
1/23/2009
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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
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Q-Med AB Has Obtained Registration Approval for Restylane(R) in China
1/7/2009
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Nitec Pharma AG's New Rheumatoid Arthritis Treatment, Lodotra, Recommended For European Regulatory Approval
1/7/2009
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Ark Therapeutics Says Gene Drug Cerepro Accepted by EU
1/6/2009
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UCB, Inc. (UCBJF.PK) Receives Complete Response Letter From U.S. FDA for Use of Cimzia(R) in Rheumatoid Arthritis Patients
1/5/2009
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US FDA Advisers to Review Eli Lilly and Company (LLY), Daiichi Sankyo Co Ltd. Clot Drug
1/2/2009
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Intercell AG Sees U.S. JE Vaccine Approval in Early 2009
12/29/2008
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AstraZeneca PLC (AZN) Says FDA Requests Seroquel Information
12/29/2008
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Says US FDA to Respond on Diabetes Drug by June
12/29/2008
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Ipsen Release: FDA Issues Complete Response Letter to Ipsen for Dysport(R) Biologics License Application
12/29/2008
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Teva Pharmaceutical Industries Limited (TEVA) Announces Tentative Approval of Generic Seroquel(R) Tablets
12/29/2008
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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
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Intercell AG Receives CHMP Positive Opinion for the Approval of IXIARO® in Europe – Vaccine Against Japanese Encephalitis
12/15/2008
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Sanofi-Aventis (France) (SASY.PA)'s Multaq to get U.S. Panel Review in March
12/1/2008
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Novartis AG (JOBS) to Combine Heart Pills as Afinitor Cancer Drug Delayed
11/20/2008
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Novo Nordisk A/S (NVO) - Research Update
11/18/2008
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Debiopharm Announces U.S. NDA Filing of Trelstar(R) 6-Month Formulation for Locally Advanced or Metastatic Prostate Cancer
11/14/2008
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3SBio Inc. (SSRX) Files for SFDA Approval of NuLeusin
11/10/2008
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Merck KGaA (MKGAF.PK)'s Erbitux Gets Green Light for Head Cancer
10/24/2008
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Meda AB (SE:MEDAa):FDA Has Accepted for Filing the First Potential Once-a-Day Nasal Antihistamine
10/24/2008
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Intercell AG Making Strides Towards Imminent Approval Of Its Japanese Encephalitis Vaccine In The United States
10/21/2008
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UK's NICE Turns Down GlaxoSmithKline (GSK)'s Tyverb Offer
10/14/2008
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Sanofi-Aventis (France) (SASY.PA), Daiichi Sankyo Co Ltd. Delay Japan's First Imported Vaccine
10/1/2008
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Medivir AB (MVIRb.F): New Drug Application (NDA) for Lipsovir(R) Submitted to US FDA
10/1/2008
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Ipsen: FDA's First-Cycle Review of Dysport(R) to Be Completed by Year-End
9/30/2008
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Eli Lilly and Company (LLY)'s (JOBS), Daiichi Sankyo Co Ltd. Prasugrel Delayed as U.S. Continues Review
9/29/2008
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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
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UCB Group (UCBJF.PK) Withdraws EU Marketing Authorisation Application for Lacosamide in Diabetic Neuropathic Pain
9/25/2008
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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
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Lundbeck Files for U.S. Approval for Serdolect
9/15/2008
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Basilea Pharmaceutica Release: FDA Accepts for Review the Complete Response to Ceftobiprole NDA Approvable Letter
9/15/2008
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Meda AB (SE:MEDAa): Anticipated Approval Of Onsolis(TM) During First Half 2009 Following Receipt of Complete Response Letter from FDA
8/28/2008
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UK's NICE Recommends Novartis Pharmaceuticals UK Limited (NVS) Eye Drug Lucentis
8/27/2008
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Meda AB (SE:MEDAa): Registration Application for Azelastine Extra Strength Submitted to the FDA
8/4/2008
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Regulatory Approval of Basilea Pharmaceutica's Toctino(R) (alitretinoin) Recommended by Concerned EU Member States
7/31/2008
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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
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U.K. Medicines Advisory Group Rejects GlaxoSmithKline (GSK)'s (JOBS) Tyverb
7/8/2008
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