Review Extension
05-31-2010 |
17:44 hs.
A Food and Drug Administration expert panel, will review Roche Holding AG cancer drug Avastin, for two new proposed uses. The drug is proposed for both breast cancer (combined with Docetaxel and also with Paclitaxel) that were not previously treated with chemotherapy alone.
Restless leg syndrome
05-26-2010 |
17:59 hs.
XenoPort Inc. announced that the Food and Drug Administration requested additional preclinical data for experimental drug Horizant (Gabapentin Enacabril) indicated to treat restless leg syndrome. The drug is jointly developed with GlaxoSmithKline Plc.
03-30-2010 |
18:26 hs.
British GlaxoSmithKline Plc. announce their intention to submit for the second time for Food and Drug Administration approval extended use of Avodart (dutasteride) as a treatment to reduce the risk of prostate cancer among men at increased risk of developing the disease.
12-04-2008 |
20:43 hs.
Swiss drug maker Roche Holding AG said that the Food and Drug Administration has delayed even further the approval of the potential blockbuster rheumatoid arthritis drug Actemra by asking for more non-clinical data concerning fertility issues. Actemra is an anti-interleukin-6 receptor antibody.
12-01-2008 |
18:00 hs.
The Food and Drug Administration delayed the approval of AstraZeneca’s Motavizumab, a drug to treat respiratory syncytial virus (RSV) and a successor Synagis. Further details.
11-24-2008 |
12:02 hs.
Another three months
06-24-2008 |
10:36 hs.
The Food and Drug Administration (FDA) announced it has extended the review period for Eli Lilly & Co and Daiichi Sankyo´s new blood-thinning drug Effient (prasugrel), delaying a decision on approval by another three months, one of the possibilities within the announced deadline review date of June 26th. Further details.
06-23-2008 |
10:47 hs.
The FDA has extended the priority review period for Glaxo’s and Ligand Pharmaceuticals’ Promacta for short-term treatment of chronic ITP for another 90 days. If approved, the compound would be the first oral platelet growth factor therapy for this condition
MK-0524A and MK-0524B
06-20-2008 |
12:45 hs.
Merck & Co. provided an update on the U.S. regulatory status of its experimental drugs MK-0524A and MK-0524B for the treatment of primary hypercholesterolemia or mixed dyslipidemia at a meeting with market analysts, saying it may have to wait until 2013 to complete the data required by the Food and Drug Administration (FDA).
