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Latest US Food and Drug Administration Stories

2009-09-16 08:00:00

TAMPA, Fla., Sept. 16 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has approved its New Drug Application for Zirgan(TM) (ganciclovir ophthalmic gel) 0.15% as a treatment for acute herpetic keratitis (dendritic ulcers). The FDA granted orphan drug designation to Zirgan for this indication in April 2007. (Logo: http://www.newscom.com/cgi-bin/prnh/20080220/CLW064LOGO )...

2009-08-28 09:42:00

Conference to Examine Latest in Healthcare Product Regulation, Trends, Technology ROCKVILLE, Md., Aug. 28 /PRNewswire-USNewswire/ -- Professionals concerned with developing and bringing safe and effective drugs, medical devices, biotechnology and other healthcare products to the worldwide market will convene in Philadelphia next month for the Regulatory Affairs Professionals Society's (RAPS) 2009 Annual Conference & Exhibition. Attendees will come from around the world for what is the...

2009-08-03 20:29:00

ANN ARBOR, Mich., Aug. 3 /PRNewswire/ -- Validation & Compliance Institute (VCI) is developing a series of training videos for the University of Michigan Medical Innovation Center (MIC). The videos will introduce University of Michigan researchers to the regulations that are required by the US Food and Drug Administration (FDA) in order to market medical devices. The training will help innovators to make decisions early in their projects that will save them time and money when they...

2009-07-07 06:00:00

BRISTOL, Tenn. and SAN MATEO, Calif., July 7 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced that on July 2, 2009, King met with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY(R) NDA and to address all FDA comments in the Complete Response...

2009-06-08 07:00:00

REHOVOT, Israel, June 8 /PRNewswire/ -- D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the trial in the coming months, in over 100 clinical sites in North America, Europe, South Africa and Israel. The forthcoming Phase III trial is a randomized, double blind, placebo-controlled study...

2009-06-06 10:00:00

- Late-Breaking Data from Pivotal BLOOM Trial Presented at the American Diabetes Association's 69th Scientific Sessions Expand on Previously Announced Positive Top-Line Results - NEW ORLEANS, June 6, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today a late-breaking poster presentation of positive results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and...

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2009-05-18 13:30:00

The health risks attributed to smoking cigarettes appear to have actually worsened over time, according to a new study.Dr. David Burns of the University of California, San Diego, presented his findings during a meeting of the Society for Research on Nicotine and Tobacco.He noted that although the nation's rate of lung cancer has decreased as more people have kicked the habit, an individual smoker's risk of cancer is actually higher.Burns found a larger increase in a type of lung cancer called...

2009-05-06 17:37:00

ROCKVILLE, Md., May 6 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that the US Food and Drug Administration (FDA) has granted marketing approval of Fanapt(TM) (iloperidone) for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase III clinical studies comparing Fanapt(TM) to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients....

2009-05-06 07:01:00

REHOVOT, Israel, May 6 /PRNewswire/ -- D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients. D-Pharm plans to initiate the trial later this year following FDA review of the IND and SPA. Recently, D-Pharm also obtained Scientific Advice from the European Medicines Agency (EMEA) on the development strategy for DP-b99...

2009-04-06 15:50:00

Agreement opens clear path to NDA for early diagnosis of Parkinsonian Syndromes HOPKINTON, Mass., April 6 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) announced today that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the Phase III protocol of Alseres' Altropane(R) Molecular Imaging Agent to aid in the early diagnosis of Parkinsonian syndromes including Parkinson's disease. A SPA...


Word of the Day
pungle
  • To take pains; labor assiduously with little progress.
This word comes from the Spanish 'pongale,' put it.
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