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- Patients Urge Implementation of FDA Advisory Committee Recommendation for Public Health Emergency; HHS Blood Safety and Availability Advisory Committee Stresses Need for Immediate Action to Protect Patients' Lives
- TOWSON, Md. & WASHINGTON -- The Immune Deficiency Foundation, The Neuropathy Association and The Myositis Association have united to urge the U.S. Secretary of Health and Human Services Secretary Mike Leavitt to heed a recent recommendation to declare a public health emergency. The recommendation was approved unanimously on May 16...
- Research articles 2005-06-02
- FDA Advisory Committee Votes in Favor of Earlier Use of Phosphate Binders in Stage 4 Kidney Disease Patients With Hyperphosphatemia.
- PHILADELPHIA, October 17 /PRNewswire/ -- PHILADELPHIA, October 17 /PRNewswire/ --
- Research articles 2007-10-16
- 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
- U.S. Food and Drug Administration Advisory Committee Recommends New Treatment, CAMPATH, for Patients With Chronic Lymphocytic Leukemia
- Health & Medical Editors/Business Writers
- Research articles 2000-12-14
- FDA Advisory Committee concludes that COPAXONE is safe and effective for treatment of patients with relapsing multiple sclerosis
- NEW YORK and JERUSALEM, Israel--BUSINESS WIRE--Sept. 19, 1996--Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVIY) today announced that a Peripheral and Central Nervous System Advisory Committee convened by the U.S. Food and Drug Administration FDA has unanimously concluded that COPAXONE (copolymer-1 for injection) is a safe and effective treatment for patients with...
- Research articles 1996-09-19
- 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
- Ligand's NDA for Panretin Gel Recommended for Approval by FDA Advisory Committee For Topical Treatment of AIDS-Related KS
- SAN DIEGO--BW HealthWire--Nov. 16, 1998--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) announced today that the Oncologic Drugs Advisory Committee to the U.S. Food & Drug Administration FDA in a series of 8 to 1 votes determined PanretinR gel alitretinoin 0.1% to be safe and effective for the topical treatment of cutaneous lesions in...
- Research articles 1998-11-16
Additional Resources
- 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
- GlaxoSmithKline Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionKevin Wilson - Citigroup Yeah, thank you this Kevin Wilson from Citigroup in London. Three questions, if I may, JP. Firstly, in the U.S., the 2% decline in sales in the quarter. Could you break out the volume and any price element you saw, and perhaps also comment...
- Earnings calls 2007-07-25
- XenoPort, Inc. Q2 2009 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator instructions Your first question comes from the line of Eric Schmidt of Cowen and Company. Eric Schmidt – Cowen and Company Good afternoon. Thanks for taking my questions. Ron, has the FDA received the open-label expansion data for 512? Ron Barrett ...
- Earnings calls 2009-08-05
- John D. Halamka, MD, MS, Joins VeriChip Corporation's Medical Advisory Board
- DELRAY BEACH, Fla. -- VeriChip Corporation (the "Company" or "VeriChip") (NASDAQ:CHIP), a provider of RFID systems for healthcare and patient-related needs, announced today that John D. Halamka, MD, MS, has joined the Company's Medical Advisory Board as well as the joint committee formed by VeriChip and Digital Angel Corporation to...
- Research articles 2007-07-19
- FDA Antiviral Drug Committee Finds AmBisome Safe and Effective for Treatment of FUO
- SILVER SPRING, Md.--BW HealthWire--July 16, 1997--NeXstar Pharmaceuticals, Inc. (NASDAQ:NXTR) and Fujisawa USA, Inc. announced that the U.S. Food and Drug Administration FDA Antiviral Drug Products Advisory Committee voted unanimously today that AmBisomeR is safe and effective as empirical therapy for presumed fungal infections in febrile neutropenic (low white blood cell...
- Research articles 1997-07-16
- Guidant's Heart Failure Therapy Unanimously Recommended for a Broader Patient Population
- INDIANAPOLIS, Ind. and ST. PAUL, Minn. -- U.S. Food and Drug Administration Advisory Committee Approval Based on Data from Company's Landmark COMPANION Heart Failure Trial
- Research articles 2004-07-28
- State Senator Announces Formation of Patient, Physician, Industry Alliance to Solve Problems of Access to Human Plasma-Based Therapies
- WASHINGTON -- At today's meeting of the U.S. Department of Health and Human Services HHS Advisory Committee on Blood Safety and Availability, Nebraska State Senator Abbie Cornett will announce the formation of the Alliance for Plasma Therapies. The Alliance, chaired by Cornett, was formed to help resolve the complex challenges...
- Research articles 2007-05-10
- BioMed News Bytes: Dyax, Human Genome Sciences, Aldagen
- Mike Havrilla submits:The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response...
- External links 2009-10-29
- Psoriasis Advocacy Group Urges FDA Panel to Approve Abatacept forRheumatoid Arthritis
- KENSINGTON, Md., Sept. 6 /U.S. Newswire/ -- "Psoriasis Cure Now," a nonprofit patient advocacy group, today urged the Food and Drug Administration's Arthritis Drugs Advisory Committee to approve abatacept for use by rheumatoid arthritis RA patKENSINGTON, Md., Sept. 6 /U.S. Newswire/ -- "Psoriasis Cure Now," a nonprofit patient advocacy group,...
- Research articles 2005-09-06
- Biogen Idec Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions. Our first question comes from Jim Birchenough with Lehman Brothers. Jim Birchenough - Lehman Brothers Hi, guys. Just wondering if you could comment, perhaps, on new patient adds that we are seeing for TYSABRI in the US and Europe? It seems like...
- Earnings calls 2007-07-24
- FDA's Prasugrel Machinations Seem Bound to Attract Doubt
- UPDATE: Dr. Sanjay Kaul was bounced from the FDA's prasugrel panel after Eli Lilly called the FDA to question his inclusion on the panel, according to HeartWire. The FDA has admitted it made a "mistake" by axing Kaul. "At every step of the way there were errors by multiple parties,"...
- Blog posts 2009-02-23
- Senate Committee's Proposals Make Hospitals Quake
- As the details of Congressional health reform proposals are made public, the knives are being sharpened for the battle to come. The American Hospital Association AHA has already joined the fight with a 15-page letter to the Senate Finance Committee SFC protesting some of its proposed changes...
- Blog posts 2009-05-18
- What Can US Learn From European Health IT Experience?
- Mainly because of the HITECH Act, part of the economic stimulus legislation passed earlier this year, the U.S. is now finally heading down the road toward widespread health IT adoption and a national health information network. But the discussion about this strategy often gets bogged down in such details as...
- Blog posts 2009-07-31
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