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).
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目前分類：FDA 公告 (120)
- Sep 17 Mon 2012 05:51
[Medscape][FDA Approvals]A 4th Option for CML: FDA Grants Approval for Bosutinib
- Sep 16 Sun 2012 04:47
[Medscape][Medical News][FDA Approvals]FDA Approves Second Oral Drug(teriflunomide (Aubagio)) for MS
The US Food and Drug Administration (FDA) has approved a second oral agent for the treatment of multiple sclerosis (MS), teriflunomide (Aubagio, Genzyme/Sanofi).
- Mar 02 Fri 2012 11:21
[Medscape][Medscape Alerts][Medscape Medical News]FDA: Avoid Use of Kaletra Oral Solution in Newborns
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
[Medscape][FDA Approvals][Medscape Education Clinical Briefs]FDA Approves Drug to Curb Risk for Preterm Birth
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.
- Jan 20 Fri 2012 07:53
[FDA Approvals]Dapagliflozin Declined by FDA
The US Food and Drug Administration (FDA) has declined approval of the novel diabetes drug dapagliflozin, asking codevelopers Bristol-Myers Squibb and AstraZeneca to provide more data about the drug's risk–benefit profile.
- Dec 23 Fri 2011 07:11
[FDA approval]Baxter receives FDA approval for ADVATE to prevent hemophilia A
Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A. ADVATE is the only antihemophilic factor approved in the United States for prophylactic use in both adults and children.
- Dec 20 Tue 2011 07:19
[FDA approval]FDA approves first drug(Jakafi (ruxolitinib)) to treat a rare bone marrow disease
FDA核准 Jakafi 治療骨髓纖維化的藥物
The U.S. Food and Drug Administration today approved Jakafi (ruxolitinib), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis.
- Dec 19 Mon 2011 07:09
[FDA approval]FDA approves first insomnia drug(Intermezzo) for middle-of-the-night waking followed by difficulty returning to sleep
- Dec 18 Sun 2011 06:57
[FDA approval]FDA approves Eylea for eye disorder in older people
- Oct 26 Wed 2011 00:41
[FDA Medwatch]Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit
- Oct 11 Tue 2011 05:25
[Medscape][FDA Approvals]Tadalafil Approved for Benign Prostatic Hyperplasia
The US Food and Drug Administration (FDA) today approved tadalafil (Cialis, Eli Lilly), a phosphodiesterase-5 inhibitor, to also treat the signs and symptoms of benign prostatic hyperplasia (BPH) as well as a combination of BPH and erectile dysfunction (ED) when the conditions coincide.
On September 26, 2011, FDA informed the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that looked at the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011 .1,2 FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
- Sep 03 Sat 2011 08:37
[Drug Safety and Availability]FDA Drug Safety Communication: Serious allergic reactions reported with the use of Saphris (asenapine maleate)
The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). TheContraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Informationsections of the Saphris drug label have been revised to include information about this risk and to inform healthcare professionals that Saphris should not be used in patients with a known hypersensitivity to the drug.
- Sep 01 Thu 2011 06:02
[FDA Approvals]FDA Approves Brentuximab for Refractory Lymphomas
The US Food and Drug Administration has granted accelerated approval of brentuximab vedotin infusion (Adcetris, Seattle Genetics, Inc) for the treatment of relapsed or refractory Hodgkin's lymphoma and systemic anaplastic large cell lymphoma.
- Aug 28 Sun 2011 09:29
[FDA Approvals]FDA Approves crizotinib (Xalkori, Pfizer) for Advanced NSCLC
The US Food and Drug Administration (FDA) has approved crizotinib (Xalkori, Pfizer) for the treatment of late-stage non-small cell lung cancer (NSCLC) in patients who express the abnormal anaplastic lymphoma kinase (ALK) gene.
- Aug 27 Sat 2011 05:13
[FDA]Safe Use Initiative: Acetaminophen Toxicity
- Jun 30 Thu 2011 06:33
[Medscape Medical News][FDA Approvals]FDA Approves New Drug（Rectiv) for Chronic Anal Fissure Pain FDA核准治療肛裂用藥膏
The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.
- Jun 28 Tue 2011 03:24
[Medscape Medical News][FDA Approvals]FDA Okays First Autologous Filler for Smile Lines
The US Food and Drug Administration (FDA) late yesterday approved the first autologous aesthetic cell therapy to improve the appearance of moderate to severe nasolabial fold wrinkles in adults.
- Jun 21 Tue 2011 06:01
[FDA Approvals]FDA Approves Ezogabine for Seizures in Adults
The US Food and Drug Administration (FDA) approved ezogabine (Potiga, Valeant Pharmaceuticals and GlaxoSmithKline [GSK]) as an add-on medication to treat seizures associated with epilepsy in adults.
- Jun 19 Sun 2011 07:25
[FDA Approvals]Injectable Gel for Fecal Incontinence Wins FDA Approval
The US Food and Drug Administration (FDA) today approved a sterile, injectable gel called Solesta (Oceana Therapeutics) to treat fecal incontinence in patients after other remedies have failed.
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