Quantcast

Latest Food and Drug Administration Stories

2014-10-07 08:29:00

NEW YORK and PETACH TIKVAH, Israel, Oct. 7, 2014 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the United States Food and Drug Administration (FDA) has designated NurOwn(TM) as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). NurOwn(TM) consists of autologous mesenchymal stem cells that have been induced to...

2014-10-06 23:08:54

As Testosterone Complaints Continue to Increase, the FDA Furthers Its Investigation into Testosterone Use by Holding a Meeting of Its Advisory Panels to Explore the Safety and Effectiveness of Testosterone Products Detroit MI (PRWEB) October 06, 2014 As testosterone lawsuit litigation moves into the discovery phase in the U.S. District Court, Northern District of Illinois, the Oliver Law Group P.C. reports that the number of testosterone lawsuit filings have increased 13 percent in the...

2014-10-06 23:00:19

FDA Reviewing the Safety of AndroGel and Other Approved Low Testosterone Treatments after Studies Linked Their Use to a Higher Risk of Heart Attacks, Strokes and Death in Certain Men Columbus, OH (PRWEB) October 07, 2014 As concerns surrounding the cardiovascular side effects of AndroGel and other currently approved low testosterone treatments continue to grow, Wright & Schulte LLC notes that one pharmaceutical company is positioning its experimental medication as a superior...

2014-10-06 16:22:57

Studies such as this examination of statistical associations have no capability to establish cause-and-effect relationships WASHINGTON, Oct. 6, 2014 /PRNewswire-USNewswire/ -- The American Chemistry Council (ACC) offers the following comments regarding the study published today in JAMA Pediatrics by A. Spanier, et al, entitled "Bisphenol A Exposure and the Development of Wheeze and Lung Function in Children Through Age 5 Years." Quotes from the following may be attributed to Steven...

2014-10-06 12:25:17

NEW YORK, Oct. 6, 2014 /PRNewswire/ -- The FDA's grant of permission of "expanded access" to Tekmira to administer an experimental medicine for Ebola highlights not only the grave threat the disease outbreak presents, but also the difficulty of bringing life-saving products such as vaccines to market, according to Kalorama Information. The healthcare market research publisher studied vaccine production in its recent report, Biopharmaceutical and Vaccine Production Markets....

2014-10-06 08:29:39

TORONTO, Oct. 6, 2014 /PRNewswire/ - Portage Biotech Inc. ("Portage" or "the Company") (OTC: PTGEF, Canadian Securities Exchange: PBT.U), is pleased to announce that its wholly owned subsidiary, Portage Pharmaceuticals Ltd (PPL) has added the following consultants to its team for further development of its PPL-003 for uveitis and planning for its potential Investigational New Drug (IND) application with FDA. PPL-003 uses a new proprietary cell permeable peptide platform technology...

2014-10-06 08:28:23

Tuesday Plenary Sessions Focus on Policies to Foster MedTech Innovation CHICAGO, Oct. 6, 2014 /PRNewswire-USNewswire/ -- The second day of AdvaMed 2014: The MedTech Conference at McCormick Place in Chicago, Ill., features plenary speakers who will explore what is being done on the local and national levels to promote medical technology innovation, as well as an in-depth discussion of how the U.S. Food and Drug Administration's (FDA) policies are affecting the industry. The morning...

2014-10-06 08:28:05

- Product strengthens growing antiretroviral franchise in the U.S. - PITTSBURGH, Oct. 3, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the U.S. launch of its Lamivudine and Zidovudine Tablets USP, 150 mg/300 mg, which is the generic version of Viiv's Combivir(®). Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of HIV-1 infection in...

2014-10-06 08:23:33

IRVINE, Calif., Oct. 6, 2014 /PRNewswire/ -- ChromaDex Corp. (OTCQB: CDXC), an innovative natural products company that provides proprietary ingredients and science-based solutions to the dietary supplement, food and beverage, cosmetic and pharmaceutical industries, has announced that two leaders of its Spherix Consulting affiliate, A. Wallace Hayes, Ph.D., senior science advisor, and Claire Kruger, Ph.D., president, served as editors for the sixth edition of the influential...

2014-10-05 23:01:59

The Actos Lawsuit Purports Takeda Pharmceuticals Knew Long-Term Use Of The Medication Could Potentially Lead To Bladder Cancer. Columbus, OH (PRWEB) October 05, 2014 An Actos lawsuit filed by Wright & Schulte LLC on behalf of a Maryland man contend that Takeda Pharmaceuticals America, Inc., which manufactures and markets Actos, did not adequately warn the plaintiff and other consumers about the risks associated with using Actos to treat diabetes. As a result, the Actos complaint...


Latest Food and Drug Administration Reference Libraries

Flavr Savr
2013-10-03 09:43:32

Flavr Savr, also known as CGN-89564, a genetically modified tomato, was the first commercially grown genetically engineered food to be granted a license for human consumption. It was produced by the Californian company Calgene, and submitted to the U.S. Food and Drug Administration in 1992. On May 18, 1994, the FDA completed its evaluation of the Flavr Savr tomato and the usage of APH(3’)II, concluding that the tomato “is as safe as tomatoes bred by conventional means” and “that the...

Chilean Sea Bass, Dissostichus eleginoides
2013-01-12 08:49:28

The Chilean sea bass is the North American name for the Patagonian toothfish. The Chilean sea bass name derived in 1977 from Lee Lantz, a fish wholesaler looking for a more attractive name for the American fish market. In 1994 the Food and Drug Administration (FDA) accepted the Chilean sea bass as an alternative name for the Patagonian toothfish. This species is native to the southern Pacific, Atlantic, and Indian Oceans, around seamounts and continental shelves in the colder waters. The...

More Articles (2 articles) »
Word of the Day
negawatt
  • A unit of saved energy.
Coined by Amory Lovins, chairman of the Rocky Mountain Institute as a contraction of negative watt on the model of similar compounds like megawatt.