FDA grants speedy review for new class of HIV drug
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NEW YORK  - U.S. regulators will review Isentress, an investigational drug for HIV infection, on a priority basis, and a decision is anticipated by mid-October, Merck & Co. said on Wednesday.
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The Food and Drug Administration announced Friday its intentions to conduct a major evaluation of its approach in dealing with safety concerns involving drugs, primarily those that are already marketed.
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WASHINGTON -- Doctors can check patients&#39; DNA when choosing medication for them, using a test the Food and Drug Administration said Thursday it has approved.
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Pharmaceutical firm Wyeth said Tuesday that the Food and Drug Administration granted fast-track status to its experimental cancer drug temsirolimus as an initial treatment for patients with advanced kidney ...
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(WASHINGTON) - The maker of a new drug to treat women&#39;s sexual dysfunction says the product is safe and should be approved without delay.
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MADISON, NJ - Pharmaceutical firm Wyeth said Tuesday that the Food and Drug Administration (news - web sites) granted fast-track status to its experimental cancer drug temsirolimus as an initial treatment for patients with advanced kidney cancer.
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The Food and Drug Administration (FDA) today cleared for marketing the first laboratory test system that will allow physicians to consider unique genetic information from patients in selecting medications and doses of medications for a wide variety of
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AIDS drugs that work through novel mechanisms and next-generation versions of existing drugs will soon offer new options for the growing number of patients whose disease no longer responds to current drugs.
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Wyeth said on Tuesday that US regulators will review on an accelerated basis its experimental drug temsirolimus as a first line treatment for advanced renal cell carcinoma.
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Government regulators now look to approve as quickly as possible medicines whose benefits exceed their risks.
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By Thomas Ginsberg, The Philadelphia Inquirer  Dec. 19--Wyeth Pharmaceuticals said today that the FDA has agreed to conduct a fast-track review of the company's new kidney cancer-fighting drug, Torisel.
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An experimental cancer drug made by Abbott Laboratories Inc. passed its first round of human testing about six months faster than usual, thanks to a new program that aims to speed drug development.
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Here's what a newly approved drug looks like.
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Scientists at Johnson &amp; Johnson Pharmaceutical Research and Development, LLC, have identified a novel anti-tuberculosis (TB) compound that works better and faster than the current standard of care in mouse models of TB infection.
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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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MONDAY, Jan. 21 (HealthDay News) -- The anti-HIV medication entravirine has been approved by the U.S. Food and Drug Administration for adults who have failed treatment with other antiretrovirals.
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A new drug to treat HIV won federal approval Friday. The Food and Drug Administration said it approved Prezista for the treatment of the human immunodeficiency virus. The drug is the first approved HIV medication for its maker, Johnson &amp;amp; Johnson. It&#039;s also the first new HIV drug approved since June 22, 2005.