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- Amgen to Review Benefits, Risks of ESA Therapy in Chronic Renal Failure Patients at FDA Advisory Committee
- Company Recommends Hemoglobin Target of 10-12 g/dL as Risk Management Approach
- Research articles 2007-09-11
- Pall Prion Removal Technology Presented to FDA Blood Products Advisory Committee
- EAST HILLS, N.Y. -- An update on Transmissible Spongiform Encephalopathies TSEs, including variant Creutzfeldt-Jakob Disease vCJD, the human form of "mad cow" disease, was a key topic at the Food & Drug Administration's Blood Products Advisory Committee meeting in Gaithersburg, Maryland today. Issues such as the number of people that...
- Research articles 2005-03-17
- FDA Advisory Committee Reviews Data on IDM Pharma's Junovan™ for Treatment of Osteosarcoma
- IRVINE, Calif. -- IDM Pharma, Inc. (NASDAQ: IDMI) today announced that the U.S. Food and Drug Administration's FDA Oncologic Drugs Advisory Committee ODAC voted 12 to 2 that the results of INT 0133, the Phase 3 trial, do not provide substantial evidence of effectiveness of Junovan mifamurtide in the treatment...
- Research articles 2007-05-09
Additional Resources
- FDA advisory panel gives Crestor thumbs up. (News).(the FDA advisory committee recommends the approval of AstraZeneca's Crestor)(Brief Article)
- THE FINISH LINE is in sight for AstraZeneca's Crestor rosuvastatin, which was recommended for approval by a Food and Drug Administration FDA advisory committee. A critical product for the company, Crestor has had a turbulent path to marketing a THE FINISH LINE is in...
- Research articles 2003-07-14
- DepoCyt Scheduled for Dec. 18, 1997 FDA Advisory Committee Meeting
- SAN DIEGO, Calif.--BW HealthWire--Nov. 10, 1997--DepoTech Corp. (NASDAQ:DEPO) Monday announced that the U.S. Food and Drug Administration FDA has advised the company that it is currently scheduling its New Drug Application NDA for DepoCyt for review by the FDA's Oncologic Drug Advisory Committee Committee on Dec. 18, 1997.
- Research articles 1997-11-10
- DepoCyt Scheduled for Nov. 16, 1998 FDA Advisory Committee Meeting
- SAN DIEGO and EMERYVILLE, Calif.--BW HealthWire--Oct. 16, 1998--DepoTech Corp. (Nasdaq:DEPO) today announced that the U.S. Food and Drug Administration FDA has advised the company that it is currently scheduling its New Drug Application NDA for DepoCytTM for the treatment of neoplastic meningitis NM from lymphomas for review by the FDA's...
- Research articles 1998-10-17
- FDA Advisory Committee to Review REZULIN Post-Marketing Data and Supplemental New Drug Application
- MORRIS PLAINS, N.J.--BUSINESS WIRE--Jan. 15, 1999--Following discussions with the U.S. Food and Drug Administration FDA, Warner-Lambert (NYSE:WLA) today announced that REZULIN troglitazone, the Company's oral therapy for type 2 diabetes, will be on the agenda at the regularly scheduled March 26th meeting of the Agency's Endocrinologic and Metabolic Drugs Advisory...
- Research articles 1999-01-15
- North American Vaccine Announces Update On FDA Advisory Committee Meeting
- BELTSVILLE, Md.--BUSINESS WIRE--Nov. 26, 1996--North American Vaccine (AMEX:NVX) maintains its policy of not commenting on interactions with the U.S. Food and Drug Administration ("FDA") in, or the status of, the FDA's review of the company's products or on rumors or press reports appearing in the media regarding the business operations...
- Research articles 1996-11-26
- ILEX's Clofarabine Scheduled For FDA Advisory Committee Review; ODAC to Review Pivotal Data for Pediatric Acute Leukemia
- SAN ANTONIO -- ILEXTM Oncology, Inc. (Nasdaq:ILXO) announced today that clofarabine will be reviewed by the U.S. Food and Drug Administration FDA Oncologic Drugs Advisory Committee ODAC on December 1, 2004. The Company previously filed a New Drug Application NDA with the FDA for approval of clofarabine for the treatment...
- Research articles 2004-09-28
- FDA Advisory Committee Recommends Approval of Photodynamic Therapy for Advanced Lung Cancer Using Laserscope's PDT Systems; Company Now Participating in Seven PDT Programs
- WASHINGTON--BW HealthWire--Sept. 3, 1998--Laserscope (NASDAQ:LSCP) announced today that the Oncologic Drugs Advisory Committee ODAC of the U.S. Food and Drug Administration FDA recommended approval of the photodynamic therapy PDT treatment for late-stage lung cancer utilizing the company's laser systems and the drug PHOTOFRINR porfimer sodium.
- Research articles 1998-09-03
- Eli Lilly & Company's Gemzar recommended by Advisory Committee to FDA for marketing for treatment of Advanced Pancreatic Cancer
- ROCKVILLE, Md.--HealthWire--July 24, 1995--GemzarR gemcitabine hydrochloride, an investigational drug by Eli Lilly and Company, for the treatment of advanced or metastatic pancreatic cancer, was recommended to be cleared for marketing today by the Oncology Drug Advisory Committee ODAC of the Food and Drug Administration FDA. Gemzar is a novel nucleoside...
- Research articles 1995-07-24
- FDA Advisory Committee Recommends Approval of Photodynamic Therapy for Advanced Lung Cancer Using Laserscope's PDT Systems; Company Now Participating in Seven PDT Programs
- WASHINGTON--BW HealthWire--Sept. 3, 1998--Laserscope (NASDAQ:LSCP) announced today that the Oncologic Drugs Advisory Committee ODAC of the U.S. Food and Drug Administration FDA recommended approval of the photodynamic therapy PDT treatment for late-stage lung cancer utilizing the company's laser systems and the drug PHOTOFRINR porfimer sodium.
- Research articles 1998-09-03
- FDA Advisory Committee Unanimously Recommends Pulmozyme For Use In Severely Ill Patients with Cystic Fibrosis
- SOUTH SAN FRANCISCO, Calif.--BUSINESS WIRE--Oct. 9, 1996-- Genentech, Inc. (NYSE:GNE) today announced that PulmozymeR dornase alfa Inhalation Solution, the company's aerosol treatment for cystic fibrosis CF, was recommended for marketing clearance by the Pulmonary Allergy Drug Advisory Committee to the U.S. Food and Drug Administration FDA for treatment of CF...
- Research articles 1996-10-09
- FDA Advisory Committee Unanimously Recommends Approval of Activase for Use in Acute Ischemic Stroke; Activase recommended to become first emergency treatment for America's most common form of stroke
- SOUTH SAN FRANCISCO, Calif.--BUSINESS WIRE--June 6, 1996-- Genentech, Inc. (NYSE:GNE) today announced that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration FDA recommended by unanimous vote that ActivaseTM (Alteplase, recombinant), the company's clot-dissolving drug, be approved for the treatment of eligible patients...
- Research articles 1996-06-06
- Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births
- SUNNYVALE, Calif. -- Adeza (NASDAQ:ADZA) today announced that its New Drug Application NDA for GestivaTM will be reviewed by the Reproductive Health Drugs Advisory Committee to the U.S. Food and Drug Administration FDA on August 29, 2006. Gestiva, a long acting form of a naturally occurring progesterone, is the company's...
- Research articles 2006-07-18
- Oscient Pharmaceuticals Announces Results of FDA Advisory Committee Meeting for FACTIVE Tablets for the Treatment of Acute Bacterial Sinusitis
- GAITHERSBURG, Md. -- Oscient Pharmaceuticals has announced the results of yesterday's meeting of the U.S. Food and Drug Administration's FDA Anti-Infective Drugs Advisory Committee. The panel voted on topics related to the Company's pending supplemental New Drug Application sNDA seeking approval for the use of FACTIVER gemifloxacin mesylate tablets in...
- Research articles 2006-09-13
- FDA Advisory Committee Agrees That Clinical Data Support the Efficacy and Safety of Zostavax™, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee agreed that the extensive data from clinical trials in more than 40,000 people support the efficacy and safety of ZOSTAVAXTM (zoster vaccine live (Oka/Merck)), the...
- Research articles 2005-12-15
- FDA Vaccines Advisory Committee Unanimously Agrees That Clinical Data from 70,000-Infant Phase III Trials Support the Efficacy and Safety of ROTATEQ®, Merck's Investigational Vaccine for Rotavirus Gastroenteritis
- WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's FDA Vaccines and Related Biological Products Advisory Committee voted unanimously that the data from the Phase III clinical trials with 70,000 infants support the efficacy and safety of ROTATEQR (rotavirus vaccine, live, oral,...
- Research articles 2005-12-14
- FDA Schedules Advisory Committee Review of BiDil
- LEXINGTON, Mass. -- NitroMed, Inc. (NASDAQ: NTMD) announced that the U.S. Food and Drug Administration stated on its website today that the Cardiovascular and Renal Drugs Advisory Committee plans to review the Company's New Drug Application NDA for the investigational drug BiDilR. BiDil is the Company's product candidate for the...
- Research articles 2005-04-29
- FDA Advisory Committee Recommends Approval of First Test to Select Potential Patients for New Biologic Drug for Breast Cancer
- COPENHAGEN, Denmark--BW HealthWire--Sept. 4, 1998--DAKO A/S today announced that HercepTestTM was recommended unanimously for approval by a joint committee of the Hematology and Pathology Devices Panel and Immunology Devices Panel to the U.S. Food and Drug Administration FDA conditional on the company providing clear guidelines on conducting the test.
- Research articles 1998-09-04
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