 |
 |
 |
||
|
||||
 |
|
| Updated Sep. 1, 2010 |
|
||||||||
 |
|
 |
|
 |
|
 |
|
 |
|
||||||||
| |
|
FDA Committee Votes Against Proposed Opioid REMS
ISSUE: SEPTEMBER, 2010 Is it R.I.P. for an opioid REMS or risk monitoring program? It is for the current version. An FDA advisory committee charged with reviewing a plan to implement a classwide Risk Evaluation and Mitigation Strategy (REMS) for opioids voted overwhelmingly on July 23 to scrap the initiative and start over toward a more stringent version. read more | |
|
FDA News
ISSUE: AUGUST, 2010 Bevacizumab (Avastin, Genentech) is likely to lose its breast cancer indication if the FDA follows the advice of its Oncologic Drugs Advisory Committee. The FDA has approved an oral soluble film formulation of odansetron (Zuplenz, Strativa) for the prevention of postoperative nausea and vomiting caused by highly and moderately emetogenic cancer chemotherapy and radiotherapy. read more | |
|
FDA News
ISSUE: JULY, 2010 FDA approves cabazitaxel for prostate cancer, nilotinib for first-line CML. Mylotarg withdrawn from market. New indication sought for trastuzumab. read more | |
|
FDA News
ISSUE: JUNE, 2010 Tarceva approved for maintenance therapy for lung cancer. Cellular immunotherapy approved for advanced prostate cancer. More abuse-resistant formulation of opioid gets the green light. Agency takes steps to reduce external infusion pump risks. read more | |
|
FDA News
ISSUE: APRIL, 2010 News from the FDA on Trelstar, bisphosphonates and new dosing regimen for Dacogen. read more | |
|
FDA News
ISSUE: MARCH, 2010 The FDA has approved rituximab for CLL. Morphine approval will resolve drug shortage. Lapatinib gets new indication. read more | |
|
FDA News
ISSUE: JANUARY, 2010 Arzerra gets accelerated approval for CLL. Istodax approved for patients with cutaneous T-cell lymphoma. Elitek effective in managing plasma uric acid read more | |
|
FDA News
ISSUE: NOVEMBER, 2009 The FDA has approved pazopanib (Votrient, GlaxoSmithKline) for patients with advanced renal cell carcinoma, OVA1 (Vermillion) a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. Three new cancer diagnostic products available. read more |
| |
| MOREFDA NEWS | |
| |
|
• |
FDA News... [10/2009] |
|
• |
FDA News... [9/2009] |
|
• |
FDA News... [8/2009] |
|
• |
FDA News... [5/2009] |
|
• |
FDA News ... [2/2009] |
|
• |
FDA News ... [11/2008] |
|
• |
FDA News... [10/2008] |
|
• |
FDA News... [9/2008] |
|
• |
FDA Strengthens Policies on Transparency, Public D... [9/2008] |
|
• |
FDA News... [7/2008] |
|
• |
New Treatment for CLL Approved... [4/2008] |
|
• |
FDA News... [3/2008] |
|
• |
New Genetic Test for Breast Cancer Patients Approv... [2/2008] |
|
• |
FDA Approves Sorafenib for Patients With Inoperabl... [1/2008] |
|
• |
FDA News... [12/2007] |
 FDA News Archives | |
| home | about us | advertise | contact | publications |