FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Cell Therapeutics, Inc. (CTIC)'s Pixantrone Due to Severe Weather Conditions
2/9/2010
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Psyadon Pharmaceuticals, Inc. Announces Regulatory Milestones and the Initiation of a Clinical Trial of Ecopipam in Lesch-Nyhan Disease
2/9/2010
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ChemGenex Pharmaceuticals Limited (CXS.AX): Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010
2/9/2010
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US FDA Staff Questions Cell Therapeutics, Inc. (CTIC) Lymphoma Drug Pixantrone Data
2/8/2010
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Strativa Pharmaceuticals Says FDA Declines Nausea Drug Approval; FDA Citing Travel Restrictions to India
2/8/2010
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IntelGenx Corp. Receives FDA Complete Response Letter CPI-300
2/8/2010
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Repros Therapeutics Inc. (RPRX) Submits Response to FDA Regarding Androxal(R) Indication for Treatment of Hypogonadal Men Wishing to Preserve Fertility
2/8/2010
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Skyepharma PLC (SKYE) Takes Over US Flutiform NDA From Abbott Laboratories (ABT)
2/5/2010
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Paladin Labs Inc. (CC:PLB) Granted Priority Review Status for Abstral(R) by Health Canada
2/4/2010
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Lux Biosciences Files for LUVENIQ(TM) Approval in US and Europe for Noninfectious Uveitis
2/4/2010
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Hemispherx Biopharma (HEB) Receives Favorable Notice Via Its Subcontractor That the FDA Seattle District Accepts Ampligen(R) Manufacturing Response
2/2/2010
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Lannett Company, Inc. (LCI) to Submit New Drug Application for Morphine Sulfate Products
2/2/2010
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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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FDA Accepts Javelin Pharmaceuticals (JAV) Dyloject(TM) New Drug Application for Formal Review
2/2/2010
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Protalix Biotherapeutics Says FDA Seeks More Data on Gaucher Drug
2/2/2010
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GlaxoSmithKline (GSK)'s (JOBS) TYKERB(R) Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
2/1/2010
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Daiichi Sankyo Co Ltd. submits a New Drug Application in Japan for CS-8958
2/1/2010
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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 Seeks More Data For Theravance, Inc. (THRX) (JOBS) Drug Vibativ; Stock Drops
1/29/2010
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Repros Therapeutics Inc. (RPRX) Gets FDA Advice on Testosterone Drug
1/28/2010
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Amylin Pharmaceuticals, Inc. (AMLN) Says Key Diabetes Drug to Launch this Year
1/28/2010
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FDA Issues Complete Response Letter for Warner Chilcott Low Dose Oral Contraceptive
1/28/2010
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Gilead Sciences Ltd. (GILD) Announces Notification of ANDA Filing for Viread(R)
1/28/2010
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EpiCept Corporation (EPCT) Pain Drug Gets Special FDA Designation
1/27/2010
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Novartis AG (JOBS) Optimistic on Generic Lovenox Approval
1/27/2010
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Roxane Laboratories, Inc. Announces the New Drug Application Approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL)
1/27/2010
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Theratechnologies Inc. (TH.TO) Says FDA Delays Fat Drug Review Date
1/26/2010
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Pfizer Inc. (PFE) (JOBS) Seeks Sutent OK for Pancreatic Cancer
1/25/2010
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Spectrum Pharmaceuticals, Inc. (SPPI) Says FDA Asks for More Data on Cancer Drug
1/25/2010
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Antigenics Inc. (Lexington, MA) (AGEN) Struggles to Obtain Regulatory Approval for Oncophage
1/25/2010
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Theratechnologies Inc. (TH.TO) Reports That the FDA Will Reschedule for Administrative Reasons the Advisory Committee Meeting to Review Tesamorelin's NDA
1/25/2010
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Somaxon Pharmaceuticals, Inc. Says Resubmits Insomnia Drug Data with FDA
1/22/2010
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Genzyme Corporation (GENZ) to Make Third Attempt at FDA Nod for Pompe Disease Drug
1/22/2010
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Lupin Pharmaceuticals, Inc. Receives FDA Tentative Approval for Memantine HCl Tablets
1/21/2010
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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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Genzyme Corporation (GENZ)s Lumizyme BLA Receives Six-Month FDA Review
1/21/2010
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NexMed (NEXM) Updates on Canadian Approval Process for Vitaros
1/19/2010
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Theratechnologies Inc. (TH.TO) Reports Date for FDA Advisory Committee Review of the Tesamorelin New Drug Application
1/19/2010
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Wyeth (WYE) (JOBS) Won't Market Sleeplessness Treatment
1/19/2010
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XenoPort, Inc. (XNPT) Says U.S. FDA Won’t Require Advisory Panel
1/15/2010
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FDA Extends Review Period for OSI Pharmaceuticals, Inc. (OSIP)'sTarceva Application for First-Line Maintenance Use in Advanced Non-Small Cell Lung Cancer
1/15/2010
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U.S. Panel Urges Approval of Recordati S.p.A Blood Drug
1/14/2010
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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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FDA Panel Backs Use Of Actelion Ltd. (ALIOF.PK)'s (JOBS) Zavesca For Rare Genetic Disorder
1/13/2010
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MannKind Corporation (MNKD) Expects FDA to Approve Inhaled Insulin; CEO Expects Approval "Within Days" of Plant Inspection
1/13/2010
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U.S. FDA Staff Question Study on Recordati S.p.A Blood Drug
1/12/2010
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FDA Panel Rejects New Use for Forest Laboratories, Inc. (FRX) (JOBS) Heart Drug
1/12/2010
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MannKind Corporation (MNKD) Updates Status of New Drug Application; FDA to Delay Review of Insulin Device
1/11/2010
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US FDA Questions Actelion Ltd. (ALIOF.PK) (JOBS) Rare Disease Drug Data
1/8/2010
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3SBio Inc. (SSRX) Applies for SFDA Registrational Trial for Feraheme(TM)
1/8/2010
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Biocryst Pharmaceuticals (BCRX)'s Partner Green Cross Files for Peramivir Regulatory Approval in South Korea
1/8/2010
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US FDA Staff Against Wider Approval of Forest Laboratories, Inc. (FRX) (JOBS) Drug
1/7/2010
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FDA Cancels Advisory Panel On Eli Lilly and Company (LLY) (JOBS) Drug Cymbalta
1/6/2010
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Watson Pharmaceuticals, Inc. (WPI) Files FDA Application for Generic Nuvigil(R)
1/6/2010
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Dainippon Sumitomo Pharma America Inc. Announces the NDA Submission of Lurasidone to the FDA for the Treatment of Schizophrenia
1/5/2010
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ARYx Therapeutics, Inc. Says FDA Backs Anticlotting Agent Development Path
1/5/2010
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U.S. Review of Pfizer Inc. (PFE) (JOBS) Vaccine Not Completed, Still Has Not Ruled on Prevnar 13
1/4/2010
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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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FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF
1/4/2010
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ADVENTRX Pharmaceuticals Inc. (ANX) Submits ANX-530 New Drug Application
1/4/2010
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Biodel Inc. (BIOD) Submits VIAject(R) New Drug Application to FDA for Treatment of Diabetes
1/4/2010
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FDA Issues Complete Response Letter for Johnson & Johnson (JNJ) (JOBS), Basilea Pharmaceutica's Ceftobiprole; Additional Information and Clinical Studies Requested
12/30/2009
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Novo Nordisk A/S (NVO) Says FDA's Victoza Feedback Delayed Beyond Year-End
12/30/2009
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Meda AB (SE:MEDAa): FDA Accepts NDA filing for Retigabine
12/30/2009
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Valeant Pharmaceuticals International (VRX)' Retigabine Accepted For FDA Review
12/30/2009
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VIVUS, Inc. (VVUS) Files for Approval of Obesity Drug Qnexa
12/29/2009
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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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Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) (JOBS) Says FDA to Give Verdict on Acthar in June
12/28/2009
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Pfizer Inc. (PFE)'s (JOBS) Lyrica Receives Complete Response Letter From FDA For Generalized Anxiety Disorder Monotherapy Treatment; Data in the NDA Insufficient to Support Approval
12/28/2009
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Mylan Inc. (MYL) Receives Tentative FDA Approval Under PEPFAR for Matrix Laboratories Limited (MAXL.BO)' New Drug Application (NDA) for Efavirenz Tablets
12/22/2009
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FDA Delays Decision on Cephalon, Inc. (CEPH) Drug for Jet Lag by 3 Months
12/22/2009
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Mylan Inc. (MYL) Seeks Approval of Generic of Merck & Co., Inc. (MRK)'s Vytorin; Expects 180 Days Exclusivity on Generic
12/22/2009
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Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles; Additional Data Needed Prior to Approval
12/22/2009
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Shire plc Submits Biologics License Application (BLA) for REPLAGAL(R) With the FDA
12/22/2009
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Arena Pharmaceuticals, Inc. (ARNA) Files for Approval for Weight Loss Drug
12/22/2009
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European Medicines Evaluation Agency Grants Cell Therapeutics, Inc. (CTIC) Orphan Drug Designation for Pixantrone in Diffuse Large B-Cell Lymphoma (DLBCL)
12/21/2009
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Cell Therapeutics, Inc. (CTIC) Says Cancer Drug Gets Orphan Status in Europe
12/21/2009
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ISTA Pharmaceuticals, Inc. (ISTA) Submits Supplemental New Drug Application to the FDA for Once-Daily XiDay(TM)
12/18/2009
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Somaxon Pharmaceuticals, Inc. Scheduled to Meet with FDA to Discuss Complete Response Letter for Silenor(R) NDA
12/18/2009
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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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Cell Therapeutics, Inc. (CTIC) Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010
12/17/2009
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Labopharm (DDS.TO) Initiates Regulatory Approval Process for Twice-Daily Tramadol-Acetaminophen in Europe
12/17/2009
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Alexza Pharmaceuticals, Inc. (ALXA) Announces Submission of AZ-004 (Staccato(R) Loxapine) NDA
12/15/2009
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Jazz Pharmaceuticals, Inc. (JAZZ) Submits New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
12/15/2009
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Endo Pharmaceuticals (ENDP)' (JOBS) AIDS Virus "Prevention" Gel Fails in African Trials
12/14/2009
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Basilea Pharmaceutica's Toctino(R) Recommended For Approval In 15 Additional European Countries
12/14/2009
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Vion Pharmaceuticals (VION) Receives Complete Response Letter for Onrigin(TM) From FDA
12/14/2009
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US FDA Staff: Roche Holding AG (RHHBF.PK) (JOBS), OSI Pharmaceuticals, Inc. (OSIP)'s (JOBS) Tarceva Effective for Wider Use
12/14/2009
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US FDA Panel to Weigh Safety of AstraZeneca PLC (AZN)'s (JOBS) Crestor
12/11/2009
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AstraZeneca PLC (AZN) Release: Advisory Committee Briefing Materials for CRESTOR(R) sNDA Available on US FDA Web Site
12/11/2009
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Salix Pharmaceuticals, Ltd. (SLXP) Reports Concurrence with FDA on Content and Format of the Pending Rifaximin NDA in the Treatment of Non-Constipation Irritable Bowel Syndrome
12/11/2009
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Gilead Sciences, Inc. (GILD) (JOBS) Says FDA Advisory Committee Supports Use Of Aztreonam For Inhalation Solution For Patients With Cystic Fibrosis
12/11/2009
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Salix Pharmaceuticals, Ltd. (SLXP) Reports Concurrence with FDA on Content and Format of the Pending Rifaximin NDA in the Treatment of Non-Constipation Irritable Bowel Syndrome
12/10/2009
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Abbott Laboratories (ABT) Seeks FDA Approval of New Dosage Strengths of SIMCOR(R) (niacin extended-release/simvastatin)
12/10/2009
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Pharming Group (PHGUF.PK) Confirms Interaction With US FDA for Rhucin
12/9/2009
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Perrigo Company (PRGO) Confirms Filing for Generic Version of Clobex(R) Spray and Announcement of Lawsuit by Galderma and Dermalogix
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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U.S. FDA Questions Studies of Gilead Sciences, Inc. (GILD) (JOBS) Fibrosis Drug
12/8/2009
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U.S. FDA Panel Backs Novartis AG (JOBS) Transplant Drug
12/8/2009
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Bristol-Myers Squibb Company (BMY), Pfizer Inc. (PFE) to Seek Apixaban Approval
12/7/2009
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Nutra Pharma Corp. (NPHC) Completes FDA Submission for Nyloxin OTC and Nyloxin Rx – Over-the-Counter and Prescription Treatments for Chronic Pain
12/7/2009
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Somaxon Pharmaceuticals, Inc. Receives Complete Response Letter from the FDA for Silenor(R), NDA Not Approved
12/7/2009
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Tris Pharma, Inc. Announces Two NDA Approvals from FDA including a Pioneering, First-Ever 24 hour Liquid Sustained Release Product
12/7/2009
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Watson Pharmaceuticals, Inc. (WPI) Files FDA Application for Generic Rozerem(R) - Paragraph IV Litigation Underway
12/4/2009
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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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US FDA Declines to Approve Endo Pharmaceuticals (ENDP) (JOBS) Testosterone Drug
12/3/2009
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Genzyme Corporation (GENZ), FDA Agree a Pathway for Lumizyme Approval
12/3/2009
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Hemispherx Biopharma (HEB)'s Ampligen Dealt FDA Blow
12/3/2009
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Cadence Pharmaceuticals, Inc. Announces FDA Extends New Drug Application Review for Intravenous Acetaminophen; PDUFA Goal Date Extended by Three Months
12/3/2009
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Javelin Pharmaceuticals (JAV) Submits Dyloject(TM) New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults
12/2/2009
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CytRx Corporation (CYTR) Announces That FDA Lifts Clinical Hold of Arimoclomol in ALS
12/2/2009
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IMPAX Laboratories, Inc. (IPXL) Acquires Rights to Abbreviated New Drug Applications From Watson Laboratories, Inc. (WPI) And Cobalt Laboratories
12/2/2009
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Johnson and Johnson Pharmaceutical Research and Development, LLC (PA) (JNJ): New Drug Application Submitted to FDA for Tapentadol Extended Release Tablets for Management of Chronic Pain
12/2/2009
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FDA Holds Up Merck KGaA (MKGAF.PK)'s (JOBS) Multiple Sclerosis Pill
12/2/2009
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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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Theravance, Inc. (THRX) Receives Complete Response Letter on the Telavancin NDA for the Treatment of Nosocomial Pneumonia
11/30/2009
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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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EMD Serono, Inc. Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application
11/30/2009
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FDA Denies Approval for Theravance, Inc. (THRX)'s (JOBS) Pneumonia Drug
11/30/2009
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Human Genome Sciences, Inc. (HGSI) Submits Biologics License Application to FDA for ZALBIN(TM)
11/25/2009
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Transcept Pharmaceuticals, Inc. (TSPT) Scheduled to Meet With FDA to Discuss Intermezzo(R) Complete Response Letter
11/24/2009
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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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GlaxoSmithKline (GSK) (JOBS) Temporarily Withdraws Avodart Cancer Filing
11/23/2009
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FDA Extends NDA Review for Neuromed Pharmaceuticals's Exalgo(TM) Extended-Release Tablets
11/20/2009
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Covidien (COV) Says FDA Extends Review of Opiod Pain Drug
11/20/2009
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FDA Advisory Committee Finds Data Support the Claim That Pfizer Inc. (PFE)'s (JOBS) SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations
11/20/2009
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EU Panel Blocks Merck KGaA (MKGAF.PK)'s (JOBS) Erbitux in Lung Cancer
11/20/2009
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Merck & Co., Inc. (MRK) (JOBS) Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R)
11/20/2009
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Dendreon Corporation (DNDN) (JOBS) Receives FDA Acknowledgement of Complete Response, PDUFA Date Assigned as May 1, 2010
11/20/2009
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FDA Panel Rejects Protein Sciences Corporation's Cell Culture Flu Vaccine, Wants More Safety Data
11/20/2009
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U.S. FDA Panel Rejects FDA and Genentech (South SF) (DNA)'s (JOBS) Xolair Asthma Drug for Children
11/19/2009
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AstraZeneca PLC (AZN) (JOBS) Asks for U.S. Approval of Brilinta
11/19/2009
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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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FDA Advisory Committee Finds Data Support the Safety and Effectiveness of Pfizer Inc. (PFE)'s (JOBS) Prevnar 13 Vaccine for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children
11/19/2009
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FDA to Review Actelion Ltd. (ALIOF.PK)'s (JOBS) Zavesca for Additional Use
11/19/2009
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Genentech (South SF) (DNA) (JOBS) and Biogen Idec, Inc. (Massachusetts) (BIIB) (JOBS) Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia
11/19/2009
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Genzyme Corporation (GENZ)'s Pompe Drug Rejected--New Production Woes
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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Roche Holding AG (RHHBF.PK) (JOBS), Genentech (South SF) (DNA) (JOBS) Apply for Avastin Advanced Breast Cancer Use
11/17/2009
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ARCA biopharma Announces Corporate and Gencaro(TM) Development Update
11/17/2009
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Genentech (South SF) (DNA) Submits Supplemental Applications to FDA for Avastin Combined with Commonly Used Chemotherapies for Women with Advanced Breast Cancer
11/17/2009
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Alkermes (ALKS) to Seek FDA Approval of Anti-Addiction Drug
11/17/2009
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Human Genome Sciences, Inc. (HGSI)'s (JOBS) Anthrax Drug Denied Approval
11/17/2009
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FDA Discusses Neuromed NDA Application for Covidien (COV)'s Exalgo
11/16/2009
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CombinatoRx, Incorporated (CRXX) And Neuromed Pharmaceuticals Receive FDA Feedback on New Drug Application for Exalgo Extended-Release Tablets
11/16/2009
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ChemGenex Pharmaceuticals Limited (CXS.AX) Announces FDA Accepts NDA for Omapro(TM) (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status
11/11/2009
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EpiCept Corporation (EPCT) Announces Health Canada Accepts Ceplene(R) Application for Review
11/9/2009
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FDA Won't Accept Merck & Co., Inc. (MRK)'s (JOBS) Application for New Drug
11/6/2009
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InterMune, Inc. (ITMN) Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF
11/4/2009
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Hemispherx Biopharma (HEB) Responding to FDA's Ampligen Questions
11/4/2009
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FDA Grants Priority Review for Shire plc's (JOBS) Velaglucerase Alfa for Type 1 Gaucher Disease; PDUFA Date is February 28, 2010
11/4/2009
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FDA Denies Approval for GTx, Inc. (GTXI) Drug; Seeks Additional Study
11/3/2009
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Dendreon Corporation (DNDN) Completes Submission of Biologics License Application for PROVENGE
11/3/2009
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MEDA: Retigabine Filings Completed in the US and Europe
11/2/2009
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Hemispherx Biopharma (HEB) Updates Chronic Fatigue Syndrome (CFS) Treatment and Commercial Application Programs
11/2/2009
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Transcept Pharmaceuticals, Inc. (TSPT) Sleep Drug Denied Approval, Stock Down 48.6% at Market Close
10/30/2009
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AstraZeneca PLC (AZN) (JOBS) Pulls Submissions for Lung Cancer Drug
10/30/2009
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Zogenix, Inc. and Desitin Pharmaceuticals GmbH Announce Filing for European Regulatory Approval of SUMAVEL(TM) DosePro(TM) - European Pivotal Trial Confirms Bioequivalence
10/28/2009
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Regeneron Pharmaceuticals, Inc. (REGN)'s Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
10/28/2009
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Lifeline BioTechnologies, Inc. (LBTN.PK) Reports on FDA Filing Status
10/26/2009
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Cephalon, Inc. (CEPH) Notified of Generic Filing for Armodafinil Tablets
10/22/2009
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FDA Declines to Approve King Pharmaceuticals®, Inc.'s Heart Imaging Drug
10/22/2009
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Shire plc Targets Fourth Quarter Filing of BLA for REPLAGAL(R) for Fabry Disease With U.S. FDA Early Access for Fabry Patients Available Under Treatment Protocol and Emergency IND
10/21/2009
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FDA Delays Endo Pharmaceuticals (ENDP)'s Testosterone Gel Approval
10/21/2009
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ADVENTRX Pharmaceuticals Inc. (ANX) Provides Business Update Following Recent Financing Activity NDA Submission for ANX-530 on Track
10/20/2009
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US FDA Delays Approval of Amgen (AMGN) (JOBS) Osteoporosis Drug
10/20/2009
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Genentech (South SF) (DNA) And Biogen Idec, Inc. (Massachusetts) (BIIB) Receive a Complete Response from FDA for Earlier Use of Rituxan for Rheumatoid Arthritis
10/20/2009
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Human Genome Sciences, Inc. (HGSI) to Seek Hepatitis Drug Approval in Q4
10/19/2009
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US Seeks More Information on Novartis AG (JOBS) Lung Drug
10/19/2009
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Amgen (AMGN)'s (JOBS) Bone Drug May Face Delays In FDA Decision
10/16/2009
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Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Resubmits Supplemental New Drug Application to FDA for H.P. Acthar(R) Gel for Treatment of Infantile Spasms
10/16/2009
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Acorda Therapeutics (ACOR) (JOBS) Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
10/15/2009
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Acorda Therapeutics (ACOR) (JOBS) Stock Trading Halted Today; FDA Advisory Committee to Review Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
10/14/2009
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Perrigo Company (PRGO) Confirms Filing for Generic Version of Men's Rogaine(R) Foam
10/13/2009
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Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
10/12/2009
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FDA Declines To Approve New Indication For Spectrum Pharmaceuticals, Inc. (SPPI) (JOBS) Fusilev; Shares Plunge
10/9/2009
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US FDA Panel Backs Wider Use of Pfizer Inc. (PFE) (JOBS) HIV Drug
10/9/2009
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US FDA Staff Says Limited Effect with Acorda Therapeutics (ACOR) (JOBS) MS Drug
10/9/2009
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CardioPharma Prepares for FDA Submission World's First Patented Triple-Combination CardiaPill(R)
10/9/2009
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FDA Fails to Approve Genzyme Corporation (GENZ)'s Clolar in Adults with AML
10/8/2009
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GlaxoSmithKline (GSK) (JOBS) Receives Unanimous FDA Panel Approval Recommendation for VOTRIENT(TM)
10/7/2009
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Genzyme Corporation (GENZ) Receives FDA Complete Response Letter for Clolar
10/6/2009
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FDA Advisory Committee Recommends Approval of Schering-Plough Corporation (SGP)'s (JOBS) PEGINTRON(R) for the Adjuvant Treatment of Stage III Malignant Melanoma
10/5/2009
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EU Agency Recommends Baxter International, Inc. (BAX)'s (JOBS) H1N1 Flu Shot
10/2/2009
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US FDA Staff Questions GlaxoSmithKline (GSK) (JOBS) Kidney Cancer Drug
10/2/2009
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FDA Finds "Subtantial" Toxicity with Schering-Plough Corporation (SGP)'s (JOBS) PegIntron Use
10/1/2009
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Discovery Laboratories (DSCO) Says FDA Agrees on Lung Drug Program
9/30/2009
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Sosei Group Corporation Announces Filing of NDA for SOH-075 (NorLevo(R)) in Japan
9/30/2009
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Labopharm (DDS.TO) Receives Notice of ANDA Submission with Paragraph IV Certification for Generic of Ryzolt(TM)
9/30/2009
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EMD Serono, Inc. Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United State
9/30/2009
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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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Cell Therapeutics, Inc. (CTIC) Applies for European Orphan Drug Designation for Pixantrone in Aggressive Non-Hodgkin's Lymphoma (NHL)
9/29/2009
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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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