Latest United States Food and Drug Administration Stories

SILVER SPRING, Md., March 25, 2013 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that it received a second complete response letter from the United States Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH). Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United...

ROCKVILLE, Md., Jan. 14, 2013 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that it received approval from the United States Food and Drug Administration (FDA) to commence a Phase I safety trial of its lead cell therapy candidate, NSI-566, in chronic spinal cord injury patients. This open-label, multi-site study, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (AIS) A level of impairment,...

SAN DIEGO, Jan. 7, 2013 /PRNewswire/ -- Orexigen(®) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced progress with the United States Food and Drug Administration (FDA) on a faster path to resubmission of the Contrave(®) (naltrexone SR / bupropion SR) New Drug Application (NDA). Consistent with the spirit of the formal dispute resolution request (FDRR) response letter issued to the Company in October by the...

PITTSBURGH, Dec. 13, 2012 /PRNewswire/ -- Cohera Medical, Inc.(®), a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that it has received approval from the United States Food and Drug Administration ("FDA") to begin the first no-drain clinical trial for its TissuGlu® Surgical Adhesive product in the U.S. The randomized, controlled, prospective multicenter non-inferiority study will compare the standard wound closure technique with...

FRAMINGHAM, Mass. and SYDNEY, Nov. 20, 2012 /PRNewswire/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the HeartWare(®) Ventricular Assist System as a bridge to heart transplantation in patients with...

WASHINGTON, Nov. 12, 2012 /PRNewswire/ -- New Phase 3 findings from a Janssen Research & Development, LLC (Janssen)-sponsored study showed treatment with the investigational intravenous (I.V.) therapy golimumab, a tumor necrosis factor (TNF) inhibitor, significantly inhibited radiographic progression in patients with active moderate to severe rheumatoid arthritis (RA) despite treatment with methotrexate. Analysis of study patients' X-rays showed significant inhibition of the...

WASHINGTON, Nov. 8, 2012 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Applications (NDA) for insulin degludec and insulin degludec/insulin aspart. (Logo: http://photos.prnewswire.com/prnh/20110414/NY80976LOGO ) At the meeting, the Advisory Committee was asked to discuss the data contained in the NDAs and subsequent...

SILVER SPRING, Md., Oct. 23, 2012 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that it received a complete response letter from the United States Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for treprostinil diethanolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH). The FDA letter questioned the clinical importance of the 6 Minute Walk Distance...

SAN DIEGO, Oct. 9, 2012 /PRNewswire/ -- Bioanalytical and pharmacokinetic specialty Contract Research Organization (CRO) MicroConstants announced today the successful completion of a five-day inspection by the United States Food and Drug Administration (FDA) for compliance with Good Laboratory Practice (GLP) regulations. On September 20, 2012, an investigator from the FDA visited MicroConstants' San Diego facility for a routine inspection to assess the CRO's overall compliance with...

QUÉBEC CITY, QC, Sept. 26, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it continues to expect to file a New Drug Application (NDA) early next year, for its oral ghrelin agonist, AEZS-130, as a diagnostic test for adult growth hormone deficiency (AGHD), after receiving notification from the United States Food and Drug Administration (FDA) that Fast Track designation had not been granted. Juergen Engel, PhD, President...