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Latest United States Food and Drug Administration Stories

2014-08-27 12:30:03

LYNDHURST N.J. and NINGBO, China, Aug. 27, 2014 /PRNewswire/ -- Amerigen Pharmaceuticals Limited ("Amerigen") and the Ningbo Menovo Pharmaceutical Co., Ltd, ("Menovo") today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market. Under the terms of the agreement, Amerigen and Menovo will jointly develop products for Amerigen to commercialize in the United States. Menovo will be...

2014-08-19 08:30:02

BELLEVILLE, ON, Aug. 19, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) today announced that it is targeting Q1/2015 for the filing of a Biologics License Application (BLA) with the United States Food and Drug Administration (FDA) for Bioniche's lead program Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) for the treatment of patients with high grade non-muscle invasive bladder cancer that have failed Bacillus Calmette-Guérin (BCG) therapy. This projected timeline...

2014-07-24 12:27:55

BUFFALO, N.Y., July 24, 2014 /PRNewswire/ -- Kinex Pharmaceuticals announced the receipt of an allowance by the US FDA for the Company's KX2-391 Ointment for the commencement of a Phase I clinical study in actinic keratosis. This is the Company's third IND to be allowed by the US FDA in the past 12 months. KX2-391 is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization. KX2-391 promotes the induction of p53, G2/M arrest...

2014-07-17 08:30:21

SAN DIEGO, July 17, 2014 /PRNewswire/ -- ViaCyte, Inc., a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, today announced that it has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes. The trial would evaluate the safety and efficacy of ViaCyte's VC-01(TM) product candidate, a stem...

2014-07-11 08:24:57

SYDNEY and BEDMINSTER, N.J., July 11, 2014 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) today provided feedback on its 9 July End-of-Review (EOR) meeting with the United States Food and Drug Administration (FDA). The meeting was held to discuss the feasibility and requirements for approving Moxduo, an immediate release Dual Opioid(®), for the treatment of moderate to severe acute pain. In advance of the meeting, QRxPharma outlined several questions to discuss with...

2014-06-27 21:43:11

BMJ-British Medical Journal US regulator has taken 84 sponsors/investigators/institutions to task over 7 years Failure to protect patient safety and poor record keeping were among the most common violations picked up by the US regulator in the running of clinical trials over a period of seven years, reveals a study published online in the Journal of Medical Ethics. The study authors reviewed the content of 84 first warning letters issued by the United States Food and Drug...

2014-06-16 08:28:27

SAN DIEGO, June 16, 2014 /PRNewswire/ -- Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, announced today that it has received premarket 510(k) clearance from the United States Food and Drug Administration (FDA) to market its IMPACT Dx(TM) Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx(TM) System. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed on the IMPACT Dx System, and is indicated...

2014-06-10 08:29:19

SAN JOSE, Calif., June 10, 2014 /PRNewswire/ -- Pulsar Vascular, the innovator and developer of the PulseRider®, a minimally invasive, aneurysm neck reconstruction device, announced today the United States Food and Drug Administration (FDA)'s approval of an Investigational Device Exemption (IDE) for the PulseRider. The IDE allows Pulsar Vascular to begin a multicenter clinical trial in support of a Humanitarian Device Exemption (HDE) to evaluate the PulseRider for US approval for...

2014-05-27 08:27:36

SYDNEY and BEDMINSTER, N.J., May 27, 2014 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Moxduo New Drug Application (NDA) for the treatment of moderate to severe acute pain. The Agency stated that there was not sufficient evidence to support approval of Moxduo at this time. The Agency indicated clinical information demonstrating a clear...

2014-04-16 12:29:50

IRVINE, Calif., April 16, 2014 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today details for its previously announced conference call and webcast to discuss the United States Food and Drug Administration (FDA) 510(k) clearance of the UltraShape(TM) System for selective non-invasive fat cell destruction for the purpose of body contouring. http://photos.prnewswire.com/prnvar/20120528/535447 The...


Word of the Day
bodacious
  • Remarkable; prodigious.
  • Audacious; gutsy.
  • Completely; extremely.
  • Audaciously; boldly.
  • Impressively great in size; enormous; extraordinary.
This word is probably from the dialectal 'boldacious,' a blend of 'bold' and 'audacious.'
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