GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The FDA grants priority review status to drug candidates that may offer major advances in treatment over existing options.
PASADENA, Calif.--(BUSINESS WIRE)--
Arrowhead Pharmaceuticals, Inc. (ARWR) is providing an update on its Heparc-2004 clinical study of ARC-520, its therapeutic candidate under clinical investigation for the treatment of chronic hepatitis B virus (HBV) infection. Heparc-2004 is a multicenter, randomized, double-blind, placebo-controlled, multi-dose study of ARC-520, which is currently being performed in up to 12 patients in the United States under an Investigational New Drug (IND).
And the diabetes drug dapagliflozin was rejected in January when the Food and Drug Administration asked for more safety information.
Timothy Anderson, an analyst with Sanford C. Bernstein & Co. in New York, said in a note to clients today that he was cutting his estimate (BMY) of 2016 sales of Bristol-Myers’ hepatitis C franchise from $2 billion to $1.2 billion.
not much would technically happen but for baraclude to work best you need it to go into your stomach while empty and let it work its magic i guess..a shock an awe effect for the virus .. i dont know teababy.. but it does make sense that the pill goes into your stomach with a free ride for it to do whatever..
im on baraclude and never really questioned it.. it kinda just made sense so i never looked into it..
good luck with baraclude.. no side effects for me thank God..
The drug will be phased out by June 8 of this year, according to a statement by the US Food and Drug Administration (FDA)."
http://www.the-scientist.com/templates/trackable/display/blog.jsp?
Food and Drug Administration in installments -- a process that typically ensures a swifter regulatory review."
Here's the link to the full article:
http://www.reuters.com/article/idCNN2110591320100421?
, Commissioner of the Food and Drug Administration, the briefing will provide an overview of the clinical trials, primary efficacy, safety, and complexity of dosing regimens. The briefing will consist of presentations by Debra Birnkrant, M.D, Director, and Jeffery Murray, Deputy Director, Division of Antiviral Products, Center for Drug Evaluation and Research (CDER), followed by an opportunity for questions from call participants.
s sudden change of opinion regarding Avandia is that it comes several years after researchers had warned about the problems associated with using the drug.
Food and Drug Administration (FDA) to ban further sale of the diet drug. 34 deaths have been disclosed of Meridia patients but states it sees no pattern to the deaths or connection to Meridia. 16 deaths resulted from cardiovascular problems
Adderall is a central nervous system stimulant.
Both of these drugs are contraindicated...a definite no-no, for people with cardiac related problems. It would be negligable for an MD to give these drugs concurrently.
Sorry, said this drug. While 5-HTP isolated from a plant certainly isn't the natural way to get tryptophan into your body (eating food is), it's still not classified as a drug and doesn't act at all like antidepressant drugs in that the brain still uses it in the way it naturally uses tryptophan combined with B-6 to manufacture serotonin. Oops.
This study is being conducted under an Investigational New Drug application (IND) that was filed with the U.S. Food and Drug Administration in December 2012. As a result of successfully filing the IND, GlobeImmune received a milestone payment from Gilead.
The GI-13020-01 Phase 1a clinical trial is a randomized, open-label, dose escalation trial assessing the safety, tolerability and immunogenicity of various doses of GI-13020 in healthy adults.
A drug can be granted fast track status by the Food and Drug Administration to help facilitate the development and to expedite the review process of new drugs that have the potential to address an unmet medical need for serious or life-threatening conditions such as hepatitis C.
GILD) today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults.
Quercetin does not appear to be FDA approved. FDA (Food and Drug Administration) is the controlling authority for all medications. If you see all the OTC's and some herbal medications will not have their approval. This is important because, it means that no scientific studies have been conducted for these medications hence interaction with other medications or their side effects would not have been studied. Hence it is difficult to comment on its effectiveness.
Warm regards.
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