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  • LONDON, April 1- A European project to streamline drug approvals moves up a gear next week when regulators sit down with the first company to have an experimental product assessed under a new flexible pilot scheme. In the United States, the Food and Drug Administration has introduced a successful "breakthrough" designation, which has speeded up approval of...

  • March 27- The United States Food and Drug Administration rejected Adamis Pharmaceuticals Corp's injection for treating severe allergic reactions, the company said. Adamis Pharmaceuticals shares were down 37 percent at $3.40 in after-market trading. The FDA raised questions related to the volume of dose delivered by the pre-filled syringe, Adamis said on...

  • March 27- The United States Food and Drug Administration rejected Adamis Pharmaceuticals Corp's injection for treating severe allergic reactions, the company said on Friday. Adamis said the questions raised by the FDA largely pertained to the volume of the dose delivered by the pre-filled injection. The company said it would meet with the FDA to discuss the...

  • NEW YORK, March 26- Olympus Corp, the largest maker of a medical device at the center of recent U.S. superbug outbreaks, issued new cleaning instructions for its equipment on Thursday, urging health providers to adopt them "as soon as possible." The U.S. Food and Drug Administration does not recommend that patients forego procedures until the brushes are shipped out,...

  • March 25- Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the Department of Health and Human Services. Emergent Bio developed the treatment, Anthrasil, as part of a $160 million contract it signed in 2005 with the Biomedical Advanced Research and...

  • March 25- Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the U.S. Department of Health and Human Services. Emergent Bio developed the treatment, Anthrasil, as part of a $160 million contract it signed in 2005 with the Biomedical Advanced Research...

  • FDA approves Emergent BioSolutions' anthrax treatment Wednesday, 25 Mar 2015 | 7:15 AM ET

    March 25- Emergent BioSolutions Inc said the U.S. Food and Drug Administration approved its treatment for inhaled anthrax, triggering a $7 million milestone payment from the U.S. Department of Health and Human Services.

  • FDA to evaluate homeopathy regulatory framework Tuesday, 24 Mar 2015 | 2:31 PM ET

    March 24- The U.S. Food and Drug Administration said it would hold a public hearing seeking information and comment on the use of products labeled' homeopathic', as well as the agency's regulatory framework for such products. The FDA issued a warning earlier this month asking consumers not to rely on asthma products labeled homeopathic that are sold over the...

  • UPDATE 1-FDA approves Abiomed's blood pump device Monday, 23 Mar 2015 | 6:16 PM ET

    March 23- The U.S. Food and Drug Administration said it approved Abiomed Inc's miniature blood pump system that maintains heart function and circulation during high-risk procedures. Angioplasty and stenting are procedures used to re-open arteries in the heart that are blocked due to coronary artery disease, a condition that is the leading cause of death in...

  • FDA approves Abiomed's blood pump device Monday, 23 Mar 2015 | 5:51 PM ET

    March 23- The U.S. Food and Drug Administration said it approved Abiomed Inc's miniature blood pump system that maintains heart function and circulation during high-risk procedures. The device, Impella 2.5 System, can be used during angioplasty and stenting, the regulator said on Monday. Angioplasty and stenting are procedures used to re-open arteries in the...

  • March 23- The U.S. Food and Drug Administration said it would not recommend changes to the prescribing or use of Eli Lilly and Co's schizophrenia drug after a review of two deaths. The FDA said its investigation into the deaths was inconclusive. It carries a boxed warning, FDA's most serious type of warning, for post-injection delirium sedation or olanzapine...

  • March 23- The U.S. Food and Drug Administration said it would not recommend changes to the prescribing or use of Eli Lilly and Co's schizophrenia drug after a review of two deaths. Elevated levels of the drug, Zyprexa Relprevv, were found in the two patients who died three to four days after receiving the injection. The FDA said its investigation into the deaths was...

  • March 23- Pfizer Inc and Eli Lilly and Co will resume a late-stage study testing their pain drug tanezumab after the U.S. Food and Drug Administration lifted a partial hold on it. Pfizer expects to receive a $200 million upfront payment from Lilly as a result of the development, the companies said on Monday. In 2013, Pfizer forged a deal with Lilly to jointly develop...

  • March 23- Pfizer Inc and Eli Lilly and Co said they planned to resume a late-stage study testing their pain drug tanezumab after the U.S. Food and Drug Administration lifted a partial hold on it. Pfizer expects to receive a $200 million upfront payment from Lilly as a result of the development, the companies said on Monday. The FDA put tanezumab and all other...

  • March 19- GlaxoSmithKline Plc's drug to treat chronic breathing problems is safe and effective enough to be approved in adults with asthma, but not adolescents, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. The FDA is not obliged to follow the advice of its advisory panels but typically does so. Glaxo licensed the product from...

  • FDA panel to discuss Ebola vaccine development in May Wednesday, 18 Mar 2015 | 8:16 AM ET

    March 18- The U.S. Food and Drug Administration said an advisory panel will discuss the development of Ebola vaccines, days after an American health worker was flown back after being tested positive for Ebola in Sierra Leone. Ebola has so far claimed about 10,000 lives in Sierra Leone, Liberia and Guinea. Other companies that are testing potential treatments for...

  • The review comes two days ahead of a meeting of FDA advisers to discuss the combination treatment, Breo Ellipta, and recommend whether or not it should be approved to treat asthma. The FDA staff said on Tuesday there were no asthma-related deaths in Breo Ellipta studies it reviewed and that data on asthma-related hospitalizations were not observed uniformly...

  • March 17- GlaxoSmithKline Plc's respiratory treatment for chronic breathing problems did not show any new safety problems in treating asthma, a preliminary review by U.S. Food and Drug Administration staff found. The review comes two days ahead of a meeting of FDA advisers to discuss the combination treatment, Breo Ellipta, and recommend whether or not it...

  • March 16- An independent panel to the U.S. Food and Drug Administration recommended unblinding a late-stage study testing Pharmacyclics Inc and Johnson& Johnson's Imbruvica, after the treatment was successful in treating two types of cancer in combination with other drugs. Pharmacyclics, which recently agreed to be acquired by AbbVie Inc, said Imbruvica...

  • These cholesterol drugs stocks are poised to move Friday, 13 Mar 2015 | 3:33 PM ET
    Surgeons performing operation

    Here are the stocks to watch heading out of this weekend's American College of Cardiology conference in San Diego.