目前分類：FDA 公告 (116)
- Mar 02 Sat 2013 09:35
- Feb 27 Wed 2013 08:17
The US Food and Drug Administration (FDA) has approved ospemifene (Osphena, Shionogi, Inc) for treating moderate to severe dyspareunia in postmenopausal women, the agencyannounced today.
- Feb 26 Tue 2013 09:54
The indication for the oral targeted agent regorafenib (Stivarga, Bayer) has been expanded by the US Food and Drug Administration (FDA); it is now approved for the treatment of gastrointestinal stromal tumors (GIST). Specifically, it is indicated for use in patients with tumors that cannot be surgically removed and no longer respond to imatinib (Gleevec) and sunitinib (Sutent), the 2 other FDA-approved treatments for this disease.
- Feb 21 Thu 2013 05:53
The US Food and Drug Administration (FDA) has approved budesonide extended release tablets (Uceris, Santarus) for the treatment of active mild to moderate ulcerative colitis in adult patients, the manufacturer announced January 16.
- Feb 08 Fri 2013 09:53
- Jan 28 Mon 2013 07:05
- Jan 03 Thu 2013 06:44
The US Food and Drug Administration (FDA) has approved loxapine ( Adasuve , Alexza Pharmaceuticals) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
- Jan 02 Wed 2013 09:02
The US Food and Drug Administration (FDA) today approved the varicella immune globulin preparation Varizig (Cangene) for reducing the severity of chickenpox infections in high-risk individuals when given within 4 days after exposure.
- Jan 01 Tue 2013 08:43
- Dec 30 Sun 2012 09:43
- Oct 26 Fri 2012 05:28
- Oct 19 Fri 2012 04:43
The US Food and Drug Administration (FDA) yesterday approved ocriplasmin intravitreal injection (Jetrea, ThromboGenics, Inc) for the treatment of symptomatic vitreomacular adhesions (VMAs), the agency announced today.
- Oct 02 Tue 2012 06:41
The US Food and Drug Administration (FDA) today approved adalimumab (Humira, Abbott Laboratories) for its seventh use: treating ulcerative colitis.
Adalimumab is now indicated for moderate to severe ulcerative colitis in adults who have not been helped by corticosteroids and other immunosuppressant medicines, the FDA stated in a press release today.
- Sep 30 Sun 2012 06:54
- Sep 18 Tue 2012 06:57
美國藥檢局核准新藥Linaclotide膠囊 (145ug) 上市，應用在原發性慢性便秘，以及大腸急躁症 (IBS) 合併便秘症。
The US Food and Drug Administration (FDA) approved the drug linaclotide (Linzess, Ironwood Pharmaceuticals) today for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
- Sep 17 Mon 2012 05:51
The US Food and Drug Administration (FDA) today approved bosutinib (Bosulif, Pfizer) as a new treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
- Mar 02 Fri 2012 11:21
Lopinavir/ritonavir oral solution (Kaletra, Abbott Laboratories) should be avoided in premature or full-term infants for the first 14 days after their due dates because of possible cardiac, renal, or respiratory problems, the US Food and Drug Administration (FDA) announced today in a safety alert announcing a label change.
- Feb 22 Wed 2012 11:34
The US Food and Drug Administration today approved hydroxyprogesterone caproate injection (Makena) to reduce the risk for preterm delivery before 37 weeks of pregnancy in women with singleton pregnancy and a history of at least 1 spontaneous preterm birth.