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  • FDA Approves Cancer Drug, Diagnostic

    August 29, 2011
    Pfizer NSCLC drug cleared, along with Abbott test

  • Dr. Reddy’s Gets FDA Warning Letter

    June 15, 2011
    Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA.

  • FDA Gives RTF to Gilead NDA

    January 26, 2011
    CMC issues halt HIV combo application

  • Boehringer’s Pradaxa Approved by FDA

    October 20, 2010
    Boehringer Ingelheim wins approval from the FDA for Pradaxa, the first new oral anticoagulant in the U.S. in more than 50 years.

  • FDA Approves Merck Asthma Drug Dulera

    June 24, 2010
    Merck received approval from the FDA for Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combo asthma treatment for patients 12 years of age and older.

  • FDA Approves Lamictal ODT

    May 11, 2009
    Eurand received approval from the FDA for EUR-1048, to be marketed as GlaxoSmithKline's Lamictal ODT (lamotrigine) Orally Disintegrating Tablets.

  • ATryn Approved by the FDA

    February 9, 2009
    GTC Biotherapeutics and Ovation Pharmaceuticals, Inc. received approval from the FDA for ATryn (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

  • FDA Delays Centocor's BLA for Psoriasis Drug

    August 8, 2008
    Centocor's BLA for ustekinumab for the treatment of plaque psoriasis has been delayed by three months to December 2008. Centocor filed the BLA late in 2007.     The FDA extended the review period in order to review amendments to the…

  • FDA Licenses First Avian Flu Vaccine

    April 18, 2007
    The FDA has licensed Sanofi Pasteur's H5N1 vaccine, the first avian flu vaccine for humans. Sanofi Pasteur, in collaboration with the National Institutes of Health, submitted a BLA to the FDA for the vaccine. The licensure is the first step in achiev…

  • FDA Advisory Committee Votes Down Merck's Arcoxia NDA

    April 13, 2007
    The FDA Arthritis Advisory Committee voted 20-to-1 against recommending approval of Merck's Arcoxia for the symptomatic treatment of osteoarthritis. The drug has been under review by the FDA as an investigational selective COX-2 inhibitor since the N…