je.st
news
Tag: fda
FDA warns of deadly liver damage with AbbVie hepatitis drugs
2015-10-25 14:37:13| Biotech - Topix.net
Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease. The Food and Drug Administration said Thursday it will require AbbVie to add new warnings to Viekira Pak and Technivie after reported deaths and liver transplants in patients who already had liver damage caused by hepatitis C. The warning could reshape the growing field of high-priced drugs to treat the virus, which also includes Gilead Sciences' blockbuster medications Sovaldi and Harvoni.
Tags: damage
drugs
liver
deadly
Premarket Biotech Digest: Gilead Gets A Boost, Zafgen's Beloranib Program, Relypsa Gets FDA Nod
2015-10-24 12:08:16| Biotech - Topix.net
Parkinson's is very difficult to diagnose- in fact, there's no real diagnostic test for PD. A doctor usually looks at your medical history, maybe some changes in behavior, and may conduct blood tests and scans to eliminate other diseases.
Tags: program
boost
digest
biotech
FDA adds liver warning to AbbVie hepatitis C drugs
2015-10-23 01:36:32| Biotech - Topix.net
Federal health officials are warning doctors and patients that two hepatitis C drugs from AbbVie can cause life-threatening liver injury in patients with advanced forms of the disease. The Food and Drug Administration said Thursday it will require AbbVie to add new warnings to Viekira Pak and Technivie about their risks for patients who already have advanced liver damage caused by hepatitis C. The warning could reshape the growing field of high-priced drugs to treat the virus, which also includes Gilead Sciences' blockbuster medications Sovaldi and Harvoni.
Tags: warning
drugs
adds
liver
Shire says FDA declines to approve eye drug Lifitegrast
2015-10-17 08:11:06| Biotech - Topix.net
The U.S. Food and Drug Administration notified Shire Plc it will not approve its eye drug Lifitegrast, the company said on Friday, adding that the U.S. health regulator recommended the company conduct additional clinical studies. The news comes over a week before the FDA was supposed to make a decision on Lifitegrast on Oct 25. Shire said it received a complete response letter, which the FDA sends to let a drug developer know a marketing application will not be approved in its present form.
FDA to Host First Public Meeting on Biotech Regulation Overhaul
2015-10-16 19:10:33| Biotech - Topix.net
On October 15, 2015, the Food and Drug Administration posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated Framework for the Regulation of Biotechnology and to develop a long-term strategy for the regulation of the products of biotechnology. The meeting notice follows the White House's Office of Science and Technology Policy's July 2015 memorandum announcing a major overhaul of the current biotech regulatory framework.
Tags: public
meeting
host
regulation
Sites : [70] [71] [72] [73] [74] [75] [76] [77] [78] [79] [80] [81] [82] [83] [84] [85] [86] [87] [88] [89] next »