目前分類：FDA 公告 (118)
- Aug 28 Wed 2013 07:43
- Aug 17 Sat 2013 07:48
The US Food and Drug Administration (FDA) today approved a new drug called dolutegravir (Tivicay, GlaxoSmithKline) as an adjunct to other antiretroviral drugs that treat individuals infected with HIV-1, the agency announced.
- Jul 28 Sun 2013 07:08
The US Food and Drug Administration has approved levomilnacipran (Fetzima, Forest Laboratories, Inc.), a new serotonin-norepinephrine reuptake inhibitor (SNRI), for major depressive disorder (MDD) in adults, making the drug the fourth SNRI to be approved in the United States.
- Jul 20 Sat 2013 08:28
- Jul 19 Fri 2013 08:36
The US Food and Drug Administration (FDA) has approved golimumab (Simponi Aria, Janssen Biotech, Inc), intravenous (IV) formulation in combination with methotrexate, for the treatment of moderately to severely active rheumatoid arthritis (RA), the company has announced today.
- Jul 13 Sat 2013 01:43
A new targeted therapy, afatinib (Gilotrif, Boehringer Ingelheim), has been approved by the US Food and Drug Administration (FDA) for use in the treatment of metastatic nonsmall-cell lung cancer (NSCLC) that tests positive for epidermal growth-factor receptor mutations (EGFRm+). A companion diagnostic test, the Therascreen EGFR PCR Kit(from Qiagen), has been approved at the same time.
- Jun 30 Sun 2013 08:20
The first nonhormonal drug for hot flashes associated with menopause was approved by the US Food and Drug Administration (FDA) today despite an agency advisory committee having rejected it as too much risk for minimal benefit.
- Jun 27 Thu 2013 08:25
The US Food and Drug Administration (FDA) yesterday approved the first recombinant coagulation factor IX (Rixubis, Baxter Healthcare) for the routine prevention of bleeding in patients with hemophilia B who are 16 years of age and older, the agency announced.
- Jun 24 Mon 2013 05:26
- Jun 06 Thu 2013 08:17
The US Food and Drug Administration has approved an expanded indication for the rivastigmine transdermal system (Exelon Patch, Novartis Pharmaceuticals Corporation) to include patients with severe disease.
- Jun 04 Tue 2013 07:58
fda核准 Simponi (golimumab) 注射劑的新的用法在成人中度與重度潰瘍性結腸炎。
The US Food and Drug Administration (FDA) today approved a new indication for the tumor necrosis factor (TNF)-alpha inhibitor golimumab (Simponi, Janssen Biotech): treatment of adults with moderate to severe ulcerative colitis that is resistant to prior treatment or requires continuous steroid therapy.
- Jun 03 Mon 2013 23:59
Two new drugs have been approved by the US Food and Drug Administration (FDA) for use in certain patients with metastatic or unresectable melanoma, along with a diagnostic test to identify patients who are suitable for treatment.
- May 18 Sat 2013 05:09
The US Food and Drug Administration (FDA) gave the marketing nod today to a novel once-daily inhaled therapy for the treatment of chronic obstructive pulmonary disease (COPD).
- May 15 Wed 2013 10:03
- May 08 Wed 2013 08:22
The US Food and Drug Administration (FDA) today approved a delayed-release version of cysteamine bitartrate (Procysbi, Raptor Pharmaceuticals) for a rare genetic disorder called nephropathic cystinosis, the agency announced.
- May 03 Fri 2013 08:26
- Apr 23 Tue 2013 04:36
The US Food and Drug Administration (FDA) has approved lubiprostone (Amitiza, Sucampo Pharmaceuticals Inc/Takeda Pharmaceuticals USA Inc), the first oral treatment for opioid-induced constipation in adults with chronic noncancer pain.
- Apr 15 Mon 2013 09:16
- Apr 12 Fri 2013 07:30
The US Food and Drug Administration (FDA) today approved the combination of doxylamine and pyridoxine (Diclegis, Duchesnay) to treat pregnant women with nausea and vomiting who have not adequately responded to dietary and lifestyle changes, the agency has announced.