Latest US Food and Drug Administration Stories
SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 9, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today results from a Pathology Working Group's (PWG) re-adjudication of female rat mammary tumor diagnoses from a two-year rat carcinogenicity study of lorcaserin.
SAN DIEGO and WOODCLIFF LAKE, N.J., Aug. 2, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today the completion of a clinical study that measured lorcaserin concentrations in human cerebrospinal fluid (CSF) and plasma and related data analyses.
TITUSVILLE, N.J., July 19, 2011 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor (NNRTI) EDURANT(TM) (rilpivirine) tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults.
The FDA today released nine new warning labels that are now mandatory to include onto packs of cigarettes in the most drastic change in smoking-related advertising in 25 years/
HERZLIYA, Israel, June 1, 2011 /PRNewswire-FirstCall/ -- On May 29, 2011 XTL has announced that its rHuEPO (recombinant human erythropoietin) drug which is currently in preparations for phase 2 clinical trial, has been granted an Orphan-drug designation by the US Food and Drug Administration (FDA) for treatment of Multiple Myeloma blood cancer. An orphan drug is defined as a drug treatment for an illness that affects a relatively small number of people in the population.
EAST HANOVER, N.J., May 5, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that the US Food and Drug Administration (FDA) approved AfinitorÂ® (everolimus) tablets for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease(4).
The FDA is requiring drugmakers to provide educational material to help train physicians on the correct use of drugs as part of the governmentâ€™s new plan to fight prescription drug abuse in the United States.
EAST HANOVER, N.J., April 12, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of AfinitorÂ® (everolimus) tablets for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin. The recommendation was provided after presentation of data from the everolimus RADIANT (RAD001 In Advanced Neuroendocrine Tumors) trial...
Drug maker GlaxoSmithKline released a new report detailing that its antidepressant Paxil could potentially make people with major depression more likely to become suicidal.