Resources
BNET Resources
- sort by:
- Relevance
- Date
- Popularity
- Millennium Plans to Submit a New Drug Application for Velcade (Bortezomib) for Injection
- In this article Millennium Pharmaceuticals, Inc. informs that the Company intends to file a New Drug Application NDA with the U.S. Food and Drug Administration FDA to market VELCADE as a treatment for relapsed and refractory multiple myeloma by early 2003. Earlier this year, VELCADE was granted fast-track status by...
- White papers
Additional Resources
- Glaxo Submits NDA To FDA For Agenerase.(new drug application; Food and Drug Administration )
- GLAXO WELLCOME has submitted a new drug application NDA to the Food and Drug Administration for Agenerase amprenavir, an HIV protease inhibitor. FDA has granted Agenerase fast-track review status. Glaxo also filed a marketing application with C GLAXO WELLCOME has submitted a new drug...
- Research articles 1998-10-26
- Abbott Will Submit New Drug Application for Synthroid.(Food and Drug Administration )(Brief Article)
- ABBOTT LABORATORIES will submit a new drug application NDA for Synthroid levothyroxine, its third best-selling US drug to comply with recent requirements by the Food and Drug Administration FDA. The FDA notice calls for manufacturers of levot ABBOTT LABORATORIES will submit a new drug...
- Research articles 2001-06-18
- Pentostatin. (Pharmaceuticals in Brief).(SuperGen Inc.'s new drug application for Nipent)(Brief Article)
- PENTOSTATIN SuperGen Inc. has received Food and Drug Adminstration FDA approval for a supplemental new drug application for Nipent pentostatin for injection allowing a site change for the ... PENTOSTATIN SuperGen Inc. has received Food and Drug Adminstration FDA approval for a supplemental new...
- Research articles 2002-06-03
- OCTREOTIDE ACETATE.(submits new drug application to Food and Drug Administration)
- OCTREOTIDE ACETATE-Novartis Pharmaceuticals Corporation, an affiliate of the Novartis Group, has submitted a new drug application NDA to Food and Drug Administration for Sandostatin LAR, a long-acting release formulation of Sandostatin (octreotide OCTREOTIDE ACETATE-Novartis Pharmaceuticals Corporation, an affiliate of the Novartis Group, has submitted...
- Research articles 1998-06-15
- Celgene files IND for thalidomide, following leprosy approval letter. (investigational new drug application filed with FDA)
- in Warren, N.J., has filed an investigational new drug application with Food & Drug Administration for the study of thalidomide for potential use in the treatment of Behcet's disease and complex aphthosis. Both conditions are chronic autoimmune d in Warren, N.J., has filed an investigational new...
- Research articles 1997-10-06
- New Drug Application Submitted to FDA for Centrally Acting Analgesic Tapentadol Immediate Release Tablets.
- AACHEN, Germany, January 25 /PRNewswire/ -- The German pain specialist Grunenthal GmbH announces that a New Drug Application NDA has been submitted to the U.S. Food and Drug Administration FDA for tapentadol immediate release IR tablets b AACHEN, Germany, January...
- Research articles 2008-01-25
- Bayer and Onyx Complete Filing of New Drug Application.
- M2 PRESSWIRE-11 July 2005-US Financial Network: Bayer and Onyx Complete Filing of New Drug ApplicationC1994-2005 M2 COMMUNICATIONS LTD RDATE:11072005 City of Industry, CA - July 11, 2005 - Biotechnology industry news provided by Financial News USA (OTC: FNWU). Bayer Pharmaceuticals ...
- Research articles 2005-07-11
- XOMA to present at BIO 2005 Annual International Conference and FDA accepts Neurocrine New Drug Application.
- M2 PRESSWIRE-14 June 2005-US Financial Network: XOMA to present at BIO 2005 Annual International Conference and FDA accepts Neurocrine New Drug ApplicationC1994-2005 M2 COMMUNICATIONS LTD RDATE:14062005 City of Industry, CA - Biotechnology industry news provide by Financial News USA (OTC: FNWU)....
- Research articles 2005-06-14
- AVANIR Submits Expanded Neurodex New Drug Application for the Treatment of Involuntary Emotional Expression Disorder
- SAN DIEGO -- AVANIR Pharmaceuticals (AMEX:AVN.R) announced today that on Friday, January 27, 2006, it completed the submission of its new drug application NDA to the U.S. Food and Drug Administration FDA for NeurodexTM, seeking marketing approval of the drug candidate for the treatment of involuntary emotional expression disorder, also...
- Research articles 2006-01-30
- CODEINE/CHLORPHENIRAMINE.(Celltech Pharmaceuticals Inc.'s new drug application for patents six years or older is accepted by FDA)(Brief Article)
- The FDA has accepted Celltech Pharmaceuticals Inc.'s new drug application to market a twice-daily ... The FDA has accepted Celltech Pharmaceuticals Inc.'s new drug application to market a twice-daily extended-release formulation of codeine and chlorpheniramine for patients six years of age or older. ...
- Research articles 2001-06-25
- Roche. (Active Pharmaceutical Ingredient Watch).(received FDA priority review status for its new drug application for a combination therapy of Pegasys and ribavirin)(Brief Article)
- ROCHE has received FDA priority review status for its new drug application for a combination therapy of Pegasys (peginterferon alfa-2a) ... ROCHE has received FDA priority review status for its new drug application for a combination therapy of Pegasys (peginterferon alfa-2a) and Roche's...
- Research articles 2002-07-22
- HELSINN Announces Submission of Supplemental New Drug Application for Aloxi(R) Injection in Post-Operative Nausea and Vomiting in USA.
- LUGANO, Switzerland, May 7 /PRNewswire/ -- HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced that a supplemental New Drug Application sNDA for AloxiR palonosetron hydrochloride Injection for the prevention LUGANO, Switzerland, May 7 /PRNewswire/ -- ...
- Research articles 2007-05-07
- Further Update on AVANIR's Neurodex™ New Drug Application
- SAN DIEGO -- AVANIR Pharmaceuticals (AMEX:AVN) announced that during discussion with the U.S. Food and Drug Administration FDA yesterday regarding AVANIR's new drug application NDA for Neurodex for the treatment of pseudobulbar affect PBA, the Agency requested that the Company provide an expansion of certain summary analyses in its application...
- Research articles 2005-09-22
- Axcan Pharma Submits Complete New Drug Application for ULTRASE.
- MONT-SAINT-HILAIRE, QUEBEC, Aug 2, 2007 CCNMatthews via COMTEX -- Axcan Pharma Inc. ("Axcan" or the "Company") (TSX:AXP)(NASDAQ:AXCA) today announced that it has submitted the complete New Drug Application ("NDA") for MONT-SAINT-HILAIRE, QUEBEC, Aug 2, 2007 CCNMatthews via COMTEX -- Axcan Pharma Inc. ("Axcan" or...
- Research articles 2007-08-02
- MedImmune Files Investigational New Drug Application for MT103 and Massachusetts General Hospital and Harvard Medical School Select Illumina HumanHap300 BeadChips.
- M2 PRESSWIRE-23 August 2006-U.S. Equity News: MedImmune Files Investigational New Drug Application for MT103 and Massachusetts General Hospital and Harvard Medical School Select Illumina HumanHap300 BeadChipsC1994-2006 M2 COMMUNICATIONS LTD RDATE:23082006 City of Industry, CA - Biotechnology industry alert provided by ...
- Research articles 2006-08-23
- CollaGenex Pharmaceuticals' New Drug Application for ORACEA® Accepted for Review by FDA; Target PDUFA Date is May 30, 2006
- NEWTOWN, Pa. -- CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) announced today that the New Drug Application NDA for OraceaR, the first orally administered, systemically delivered drug developed to treat rosacea, has been accepted for review by the U.S. Food and Drug Administration FDA. The NDA for Oracea was submitted to the FDA...
- Research articles 2005-10-03
- InKine Announces the Acceptance for Filing of Its New Drug Application for Its Next Generation Purgative Product — INKP-102
- BLUE BELL, Pa. -- InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced that the United States Food and Drug Administration FDA has accepted for filing InKine's New Drug Application NDA for INKP-102, the Company's next-generation purgative product. The successful filing of the NDA denotes that the FDA has determined that...
- Research articles 2005-07-26
- Hyal Pharmaceutical Corporation Announces FDA Acceptance Of New Drug Application For Solarase
- MISSISSAUGA, Ontario--BUSINESS WIRE--Dec. 22, 1998--Hyal Pharmaceutical Corporation (NASDAQ:HYALF) (TSE:HPC) ("Hyal") announced today that the U.S. Food and Drug Administration ("FDA") has officially accepted for review the New Drug Application ("NDA") for Solarasetm. The FDA's acceptance indicates that the application was properly filed and contains sufficient data to warrant further review...
- Research articles 1998-12-22
- Alpharma to Withdraw and Resubmit Its New Drug Application for EMBEDA(TM)
- Alpharma Inc. (NYSE: ALO), a global specialty pharmaceutical company, today announced that it has withdrawn its New Drug Application ("NDA") for EMBEDA™ (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules, and plans to resubmit a revised application as soon as possible. While the initial NDA submission qualified for a...
- Research articles 2008-04-21
- << Previous
- page 1 of 1
- Next >>
