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*FDA advisory panel votes against approval of tivozanib. May 2- An advisory panel to the U.S. Food and Drug Administration recommended that the agency reject a kidney cancer drug made by Aveo Pharmaceuticals Inc and Astellas Pharma Inc, saying data from the clinical trial were inconsistent.
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An antibiotic-resistant strain of gonorrhea has some saying that its effects could match those of AIDS.
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Lawyers with the Justice Department filed the appeal with the 2nd U.S. Circuit Court of Appeals in New York, according to court documents. District Judge Edward Korman's ruling from April 5 that required the FDA to make the emergency contraception available over-the-counter to women of all ages within 30 days.
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Lawyers with the Justice Department filed the appeal with the 2nd U.S. Circuit Court of Appeals in New York, according to court documents. District Judge Edward Korman's ruling from April 5 that required the FDA to make the emergency contraception available over-the-counter to women of all ages within 30 days.
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Lawyers with the Justice Department filed the appeal with the 2nd U.S. Circuit Court of Appeals in New York, according to court documents. District Judge Edward Korman's ruling from April 5 that required the FDA to make the emergency contraception available over-the-counter to women of all ages within 30 days.
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May 1- Drugs from Amgen Inc, Teva Pharmaceutical Industries and Sanofi that boost white blood cells are being evaluated by U.S. regulators as treatments for radiation exposure caused by a nuclear attack or accident.
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May 1- Drugs from Amgen Inc, Teva Pharmaceutical Industries and Sanofi that boost white blood cells are being evaluated by U.S. regulators as treatments for radiation exposure caused by a nuclear attack or accident.
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The FDA has lowered the age limit for Plan B One-Step emergency contraceptive to 15. The pill will be available without a prescription and stocked on store shelves.
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*Communicated the new strategy to the U.S. food and drug administration. and other global regulatory agencies. *Actions will include investments in retirement and replacement programs,.
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The FDA said its approval was not related to the judge's ruling. Teva originally applied to sell Plan B to all females of reproductive age, but changed its latest bid to those 15 and older after 2011. The amended application was pending when Judge Edward Korman handed down his ruling, the FDA said.
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April 30- U.S. Food and Drug Administration:. *FDA says approves plan b one-step emergency contraceptive without a. *FDA says Teva indicated willingness to conduct audit of age verification.
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April 30- Generic drugmaker Mylan Inc said on Tuesday it hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.
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April 30- Generic drugmaker Mylan Inc said on Tuesday it hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.
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April 30- Generic drugmaker Mylan Inc said on Tuesday it has hired Deborah Autor, deputy commissioner for global regulatory operations and policy at the U.S. Food and Drug Administration, to help oversee its global regulatory strategy.
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The FDA said on Monday it was taking a "fresh look" at the issue in response to the launch of a caffeinated gum, "and if necessary, will take appropriate action." While the FDA did not name the gum in its statement, Wrigley launched the product this month.
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*FDA approves Procysbi for rare genetic disorder. WASHINGTON, April 30- The U.S. Food and Drug Administration has approved an experimental drug from Raptor Pharmaceutical Corp to treat a rare genetic disorder that can cause irreversible tissue damage, organ failure and premature death.
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*FDA approves Procysbi for rare genetic disorder. WASHINGTON, April 30- The U.S. Food and Drug Administration has approved an experimental drug from Raptor Pharmaceutical Corp to treat a rare genetic disorder that can cause irreversible tissue damage, organ failure and premature death.
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The FDA said on Monday it was taking a "fresh look" at the issue in response to the launch of a new caffeinated gum, "and if necessary, will take appropriate action." While the FDA did not name the gum in its statement, Wrigley launched the product this month, the latest to tout added caffeine.
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The FDA said on Monday it was taking a "fresh look" at the issue in response to the launch of a new caffeinated gum, "and if necessary, will take appropriate action." While the FDA did not name the gum in its statement, Wrigley.
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*FDA staff question sends Aveo shares down as much as 21.3 pct. April 30- Staff reviewers for the U.S. Food and Drug Administration will ask a panel of outside medical experts on Thursday whether another clinical trial is needed before an experimental kidney cancer drug made by Aveo Pharmaceuticals Inc.