Resources
BNET Resources
- sort by:
- Relevance
- Date
- Popularity
- 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
- 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
- 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
- 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
- Eli Lilly Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions And our first question comes from the line of James Kelly of Goldman Sachs. Please go ahead. James Kelly - Goldman Sachs Thank you and good morning. My question relates to Zyprexa and the depot formulation, and thank you for the additional data in Canada...
- Earnings calls 2007-07-24
- 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
- FDA: Rezulin no sign of FDA fault...
- The FD/s decision in March that Warner-Lambert's Rezulin should be withdrawn from the market was not a sign that "things went wrong" in the agency's regulation of the drug, CDER Director Janet Woodcock says. "We have been fully aware of the hepatotoxicirty of this drug, as evidenced by the advisory...
- Research articles 2000-05-01
- FDA gets a medical device ombudsman
- The FDAs decision in March that Warner-Lambert's Rezulin should be withdrawn from the market was not a sign that "things went wrong" in the agency's regulation of the drug, CDER Director Janet Woodcock says. "We have been fully aware of the hepatotoxicity of this drug, as evidenced by the advisory...
- Research articles 2000-05-01
- 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
- 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
- Acusphere Inc. Q3 2008 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions Your first question comes from Jason Napodano – Zacks Investment Research. Jason Napodano - Zacks Investment Research I appreciate the update, you actually answered a lot of the questions that I was going to ask, but I’ve got a couple here. The...
- Earnings calls 2008-11-10
- Icahn Bruising For Proxy Battle With Amylin Management
- [caption id="attachment_248" align="alignleft" width="200" caption="Byetta"][/caption] Activist investor Carl Icahn announced in a regulatory filing with the Securities and Exchange Commission his intention to nominate a slate of five directors to the board of Amylin Pharmaceuticals at the drugmaker’s May 2009 annual...
- Blog posts 2009-01-29
- Ligand Pharmaceuticals Incorporated Q1 2008 Earnings Call Transcript
- Question-and-Answer Session Operator Operator instructions Your first question comes from the line of David Webber with Broadpoint Capital. David Webber – Broadpoint Capital Thank you. Couple questions, first just to clarify the projection of $20 million in royalties, is that from AVINZA alone or is...
- Earnings calls 2008-05-20
- << Previous
- page 1 of 1
- Next >>
