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Posts Tagged ‘FDA’

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Clinical trials of FDA-approved psoriasis treatments can be a good option

January 19th 2011 | Biologics, Psoriasis Research, Treatment | 0 Comments
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Even treatments that are already approved by the U.S. Food and Drug Administration (FDA) are frequently tested further in clinical trials under close medical supervision. Such trials typically offer free meds and thorough medical screening – a great deal for patients. Check out our full report on psoriasis research studies for FDA-approved treatments.
With more
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Abbott withdraws application to market briakinumab for psoriasis

January 15th 2011 | Biologics, Psoriasis Research, Side-effects of treatment | 11 Comments
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Abbott today announced in a securities filing that it has withdrawn its application with the U.S. Food and Drug Administration (FDA) and European regulators to market its much-anticipated, experimental psoriasis treatment briakinumab (ABT-874, Ozespa). The biologic, like Centocor Ortho Biotech’s Stelara (ustekinumab), targets two internal proteins linked to inflammation, IL-12 and IL-23. Briakinumab
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Methotrexate Injection recall

November 1st 2010 | Misc. | 0 Comments
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Some injected methotrexate has been recalled. If you take methotrexate by injection, review this announcement from Sandoz to determine if your methotrexate is covered by this limited recall.

Stelara (ustekinumab) approved by FDA for psoriasis

September 25th 2009 | Biologics, Treatment | 0 Comments
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Stelara (ustekinumab) was just approved by the US FDA for moderate to severe plaque psoriasis. Dosing will be just four times per year after an initial two doses in the first month. Read more here. The treatment will be administered by a health care provider (nurse, doctor, etc.), not by the patient at home.

Stelara FDA review extended

May 26th 2009 | Biologics, Psoriasis Research | 0 Comments
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The US Food and Drug Administration (FDA) has extended its time-frame for review of the promising new biologic Stelara (ustekinumab) for moderate to severe psoriasis by 90 days. That would mean we can expect a decision about Stelara by the fall of 2009. Stelara has already been approved for use in Canada.

New biologic Simponi (golimumab) approved for psoriatic arthritis by FDA

May 26th 2009 | Biologics, Treatment, psoriatic arthritis | 0 Comments
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On April 24, the U.S. Food and Drug Administration (FDA) approved Simponi (golimumab) for the treatment of three forms of arthritis, including active psoriatic arthritis. Described in media reports as a “potential blockbuster drug,” Simponi is administered once monthly via injection under the skin. As WebMD put it: “Simponi is in a
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Raptiva (efalizumab) being pulled from US market

April 8th 2009 | Biologics, Immune system | 1 Comment
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Genentech has decided to remove Raptiva (efalizumab) from the US market. Raptiva will become unavailable in June, 2009.
All psoriasis patients currently on Raptiva should see their physician at once and not stop taking Raptiva without consulting their physician, as significant worsening of psoriasis can occasionally occur with an abrupt withdrawal of the drug.
Raptiva was
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Important information about Raptiva (efalizumab) and PML

February 24th 2009 | Biologics, Immune system | 0 Comments
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Raptiva is being pulled from the US market as of June 2009 due to safety issues. **See your physician before stopping Raptiva treatment.** More info at Raptiva.com.

FDA seeks more information before deciding about Stelara (ustekinumab) for psoriasis

December 19th 2008 | Biologics, Treatment | 0 Comments
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Statement issued today from Centocor about Stelara (ustekinumab):
Centocor, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab. …
The Complete Response letter requests additional information, including a proposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS). … The ustekinumab
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Raptiva gets new warning

November 17th 2008 | Biologics, Immune system | 0 Comments
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From a Genentech news release:
Genentech, Inc. (NYSE:DNA) announced today that the company has issued a Dear Healthcare Provider letter to inform dermatologists and neurologists of a 2nd case of progressive multifocal leukoencephalopathy (PML) which resulted in the death of a 73-year old woman who had received Raptiva (efalizumab) for approximately four years for treatment of
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