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Latest Food and Drug Administration Stories

2014-07-29 08:32:30

BELLEVILLE, ON, July 29, 2014 /PRNewswire/ - Bioniche Life Sciences Inc. (TSX: BNC) today announced the submission to the US Food and Drug Administration (FDA) Office of Orphan Products Development, an application for Orphan Drug Designation for its Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) sterile suspension for the treatment of patients with Bacillus Calmette-Guérin (BCG) refractory/relapsing high grade non-muscle invasive bladder cancer. The decision to proceed...

2014-07-29 08:32:10

-- 2014 Nomination follows Previous Nomination in 2013 -- WOODCLIFF LAKE, N.J. and SAN DIEGO, July 29, 2014 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that BELVIQ(®) (lorcaserin HCl) has been nominated by the Galien Foundation and Awards Committee for the 2014 Prix Galien USA Award in the Best Pharmaceutical Agent category. BELVIQ was previously nominated for this award in 2013. "Eisai's commitment to patient care is the driving force behind our...

2014-07-28 16:26:45

Portugal approves reimbursement for ILUVIEN ATLANTA, July 28, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Norwegian Medicines Evaluation Board has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered...

2014-07-28 08:28:49

TORONTO, July 28, 2014 /PRNewswire/ - Lorus Therapeutics Inc. (TSX: LOR) today announced that the Food and Drug Administration (FDA) completed its review and cleared the company's Investigational New Drug (IND) application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), lymphomas and multiple myeloma. Clearance of the IND allows Lorus to initiate a Phase 1b, multi-center, open-label,...

2014-07-27 23:02:31

Louisiana’s NaturaLyte and GranuFlo Lawsuit Alleges Fresenius Medical Care Deceived the State into Believing the Recalled Dialysis Products Were Safe and Submitted Requests for Medicaid Reimbursements Columbus, OH (PRWEB) July 27, 2014 Wright & Schulte LLC has learned that the state of Louisiana has filed a GranuFlo lawsuit against Fresenius Medical Care North America and its nearly 100 clinics in Louisiana over the recalled dialysis drugs GranuFlo and NaturaLyte. The complaint...

2014-07-27 23:02:21

Reports of Xarelto Bleeding Mounts As Doctors Are Prescribing Xarelto Over Pradaxa and Seeing a Rise In Adverse Events While Xarelto Lawsuits Begin to be Filed Reports Wright & Schulte LLC Columbus, OH (PRWEB) July 27, 2014 The Institute of Safe Medication Practices (ISMP) Found that the number of serious adverse events such as Xarelto bleeding side-effects reported after the use of the Xarelto blood thinner has now out numbered the complaints filed for its competitor Pradaxa, notes...

2014-07-26 23:02:52

The FDA Has Changed the Medication Guide for the Testosterone Therapy Drug AndroGel to Include The Risks of Blood Clots in the Legs and Lungs as Testosterone Treatment Lawsuits Rise to 156 Filings Reports Wright & Schulte LLC Columbus, OH (PRWEB) July 26, 2014 The U.S. Food & Drug Administration (FDA) has released an updated medical guidelines list that includes a new medication guide for AndroGel to include blood clots in the legs and lungs as a serious side-effect of taking the...

2014-07-26 23:02:48

A Depuy Pinnacle Hip Lawsuit Filed On Behalf of an Ohio Man Alleges Possible Metal Poisoning, Bone Loss And Other Future Health Complications Due To the Artificial Hip Implant Columbus, OH (PRWEB) July 26, 2014 Another DePuy Pinnacle hip lawsuit against Johnson & Johnson and its subsidiary, DePuy Orthopedics, Inc., has been filed by Wright & Schulte LLC. This DePuy Pinnacle hip lawsuit has been filed on behalf of an Erie County, Ohio man who alleges that he has had pain and...

2014-07-26 23:02:15

http://www.DrugNews.net is the largest source for prescription device warnings, research, side effects and legal news. Visit the DrugNews Center today. Orlando, FL (PRWEB) July 26, 2014 The birth control safety center at DrugNews.net is alerting women using the Mirena IUD contraceptive of new legal information on the site. A federal panel recently issued a new report showing the number of lawsuits pending for July alleging side effects from the device*. DrugNews is a free resource for...

2014-07-26 00:20:52

REDWOOD CITY, Calif., July 25, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso(TM) (sufentanil sublingual tablet system). The Company is currently...


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
lambent
  • Licking.
  • Hence Running along or over a surface, as if in the act of licking; flowing over or along; lapping or bathing; softly bright; gleaming.
This word comes the Latin 'lambere,' to lick.
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