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Latest Food and Drug Administration Stories

2014-08-11 16:28:15

SARASOTA, Fla., Aug. 11, 2014 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today that it filed with the Securities Exchange Commission its Form 10-Q for the second quarter ended June 30, 2014. The company has also announced a clinical and regulatory update. http://photos.prnewswire.com/prnvar/20140811/135143 Second Quarter, 2014: For the three months ended...

2014-08-11 16:28:03

-- FDA Approval of Omidria(TM) Received on May 30, 2014 - SEATTLE, Aug. 11, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced financial results and highlights for the second quarter of 2014, which include: -- 2Q...

2014-08-11 08:30:05

All studies on track for completion and final study reports by November 2014 MALVERN, Pa., Aug. 11, 2014 /PRNewswire/ -- SCILEX Pharmaceuticals, Inc., a company engaged in the development and commercialization of late-stage pharmaceutical products focused on the treatment of pain, announced today that it has completed patient enrollment for the dermal safety studies and the pivotal pharmacokinetic study related to its investigational product Ztlido (lidocaine patch 1.8%), a...

2014-08-11 08:29:12

Meeting with FDA Clarifies Path Forward CASTLE ROCK, Colo., Aug. 11, 2014 /PRNewswire/ -- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1(TM) Test, a rapid, multi-analyte assay for aiding in identifying children, adolescent and young adult patients who are at low risk for appendicitis, will host an investor conference call to discuss business updates, including discussion on the progress of...

2014-08-11 08:28:44

PITTSBURGH, Aug. 11, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Capecitabine Tablets USP, 150 mg and 500 mg, the generic version of Genentech's Xeloda® Tablets. 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 as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers.(1) CEO...

2014-08-09 23:03:28

Court Documents Indicate a Number of Xarelto Bleeding Lawsuits Have Been Filed In U.S. Courts on Behalf of Individuals Who Allegedly Suffered Life-Threatening Internal Hemorrhage Due to Their Use of the Blood Thinner Columbus, OH (PRWEB) August 09, 2014 Wright & Schulte LLC has launched a new Xarelto lawsuit page in response to the growing litigation involving the blood thinner. According to a Reuters report published June 14, 2014, Bayer AG and Janssen Pharmaceuticals are named as...

2014-08-09 23:00:20

The FDA Is Seeking Input From Its Advisory Panels As Testosterone Lawsuits Mount And Reports That Low Testosterone Medication Purportedly Cause Heart Attacks And Strokes Reports Wright & Schulte LLC Columbus, OH (PRWEB) August 10, 2014 As Testosterone Lawsuits claims continue to be filed in a industry-wide consolidation, Wright & Shulte LLC reports the U.S. Food & Drug Administration (FDA) has called for a meeting to be held on September 17 for two of its advisory panels to...

2014-08-08 23:07:05

http://www.DrugNews.net is the largest source for prescription device warnings, research, side effects and legal news. Visit the DrugNews Center today. New York, NY (PRWEB) August 08, 2014 The birth control safety center at DrugNews.net is alerting women using the Mirena IUD contraceptive of new research information on the site. A recent study found a higher incidence of breast cancer among women using the device* DrugNews is a free resource for those using popular prescription drugs and...

2014-08-08 23:06:38

On August 5, the US FDA issued a safety communication on adverse events associated with the unapproved use of the Expression product as a dermal filler. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 08, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Expression Injectable. The FDA issued a...

2014-08-08 16:23:03

FDA Should Close Gaps by Addressing Marketing and Flavors that Appeal to Kids WASHINGTON, Aug. 8, 2014 /PRNewswire-USNewswire/ -- In public comments jointly filed today, 24 leading public health and medical organizations called on the Food and Drug Administration to issue a final rule to regulate all tobacco products by April 25, 2015 - one year after the FDA issued a proposed rule - and to reject a proposal to exempt so-called "premium cigars." The health groups also called on FDA...


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...

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Word of the Day
kenspeckle
  • Having so marked an appearance as easily to be recognized.
This word may come from the Swedish 'kanspak,' quick at recognizing persons or things, or else from confusion with 'conspicuous.'