Quantcast

Latest U.S. Food and Drug Administration Stories

2014-08-19 12:28:32

For U.S. Media Only RIDGEFIELD, Conn., Aug. 19, 2014 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat(®) inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including...

2014-08-19 08:29:50

VAL-083 Phase I/II VAL-083 clinical trial advances to 50mg/m(2) cohort VANCOUVER, British Columbia and MENLO PARK, Calif., Aug. 19, 2014 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar" "the company") announced today a protocol amendment to allow for expanded dosing in its VAL-083 clinical trial had been filed with the U.S. Food and Drug Administration (FDA) and that a new cohort of a new 50mg/m(2) has been opened at three clinical trial sites in the United...

2014-08-13 16:26:02

THOUSAND OAKS, Calif., Aug. 13, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp(®) (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. Lots 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B,...

2014-08-11 16:27:34

REDWOOD CITY, Calif., Aug. 11, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported financial results for the three and six months ended June 30, 2014. On July 25, 2014, AcelRx announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company's new...

2014-08-07 04:21:40

SEATTLE, Aug. 7, 2014 /PRNewswire/ --CTI BioPharma Corp. (CTI or the Company) (NASDAQ and MTA: CTIC) announced today that pacritinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose...

2014-08-06 16:28:59

-- Transformational H1 2014 includes presentation of Phase 3 ASCEND data, NDA resubmission and target PDUFA date of Nov. 23 for pirfenidone in U.S. - BRISBANE, Calif., Aug. 6, 2014 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced results from operations for the second quarter ended June 30, 2014. The company also highlighted recent clinical development and business highlights, and updated its forward-looking financial guidance for 2014. InterMune reported Esbriet(®)...

2014-08-05 23:01:25

Food makers who want to label their products “gluten free” have to start following stricter rules starting today. Gluten-Free Living magazine answers the top 20 questions about those rules. Braintree, MA (PRWEB) August 05, 2014 The growing number of food makers who want to label their products “gluten free” have to start following stricter rules starting today. Today is the deadline for compliance with the U.S. Food and Drug Administration’s new gluten-free labeling rules, which...

2014-08-04 08:28:51

HAYWARD, Calif., Aug. 4, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a re-inspection of the Company's Hayward, California manufacturing facility from June 16 to July 31, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations. The FDA did not provide any status or classification to these...

2014-08-04 08:27:33

- Results from Phase I program in glioblastoma multiforme presented at ASCO earlier this year NORTH CHICAGO, Ill., Aug. 4, 2014 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with...

2014-08-04 08:26:39

Advisory Committee Votes in favor of the Safety, Efficacy and Risk Benefit of TissuGlu PITTSBURGH, Aug. 4, 2014 /PRNewswire/ -- Cohera Medical, Inc.(®), a leading innovator and developer of absorbable surgical adhesives and sealants, announced today that the U.S. Food and Drug Administration (FDA) General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted unanimously, 11 to 0, on the Safety, 6 to 5 on Efficacy, and 6 to 4 (with one abstention) on the...


Word of the Day
barratry
  • The offense of persistently instigating lawsuits, typically groundless ones.
  • An unlawful breach of duty on the part of a ship's master or crew resulting in injury to the ship's owner.
  • Sale or purchase of positions in church or state.
This word ultimately comes from the Old French word 'barater,' to cheat.
Related