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Latest U.S. Food and Drug Administration Stories

2014-08-01 23:00:46

Power morcellators, used during hysterectomy and fibroid removal procedures may potentially spread various hidden cancers in women’s bodies. Port Washington, New York (PRWEB) August 01, 2014 Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices and drugs reports that Johnson & Johnson announced it would be recalling its Ethicon surgical power morcellator devices used for the removal of fibroid masses. The device...

2014-07-31 23:14:43

CR urges U.S. Food and Drug Administration to take stronger steps to reduce the dangers of pain-relief medications YONKERS, NY (PRWEB) July 31, 2014 Some pain relief medications can be as addictive as heroin and are rife with deadly side effects. Every day, 46 people in the U.S. die from legal pain pills and for each death, more than 30 people are admitted to an emergency room because of opioid complications. Consumer Reports has taken a close look at the dangers of prescription and...

2014-07-31 23:06:58

Zoll, Kranz & Borgess, LLC, (ZKB), an experienced pharmaceutical and medical device litigation firm, is currently investigating claims of individuals who were diagnosed with cancer after a hysterectomy or myomectomy (removal of uterine fibroids) using a power morcellator device. Toledo, Ohio (PRWEB) July 31, 2014 In a front-page story, the Wall Street Journal (7/30) reports that the pharmaceutical giant, Johnson & Johnson, is withdrawing its laparoscopic power morcellator due to...

2014-07-29 23:07:42

1WorldSync announces B. Braun Melsungen AG, one of the world’s leading healthcare suppliers will utilize the Global Data Synchronization Network™ (GDSN®) standard and leverage 1WorldSync’s product information network. Lawrenceville, NJ (PRWEB) July 29, 2014 1WorldSync announces B. Braun Melsungen AG, one of the world’s leading healthcare suppliers will utilize the Global Data Synchronization Network™ (GDSN®) standard and leverage 1WorldSync’s product information...

2014-07-29 08:32:31

HAYWARD, Calif., July 29, 2014 /PRNewswire/ -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a general GMP inspection and a Pre-Approval Inspection (PAI) for RYTARY(TM )at the Company's Taiwan manufacturing facility from July 21 to July 26, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in...

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...

2014-07-24 12:28:04

DUBLIN, July 24, 2014 /PRNewswire/ -- Perrigo Company (NYSE: PRGO; TASE) today announced that it has received an AB therapeutic equivalent rating from the U.S. Food and Drug Administration (FDA) for its previously approved New Drug Application (NDA) for testosterone gel 1.0%. FDA concluded that Perrigo's testosterone product is therapeutically equivalent to [AbbVie's] AndroGel 1% and can be substituted with the full expectation that it will produce the same clinical effect and safety...

2014-07-24 08:31:47

SAN DIEGO, July 24, 2014 /PRNewswire/ -- Cypher Genomics, Inc., the genome informatics company, announced today the appointment of Henry (Hank) Nordhoff as executive chairman of Cypher's board of directors. Nordhoff directed Gen-Probe for 15 years as president and CEO and served as chairman of Gen-Probe's board of directors. In addition, Cypher appointed as directors: Herbert Boyer, Ph.D., who co-founded and led Genentech as vice president, and Andrew von Eschenbach, M.D., who was the...

2014-07-23 16:28:25

WHITE PLAINS, N.Y., July 23, 2014 /PRNewswire-USNewswire/ -- Today's U.S. Food and Drug Administration (FDA) approval of idelalisib to treat patients with relapsed chronic lymphocytic leukemia (CLL), follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) is a significant advance for patients with these blood cancers. Idelalisib, which goes by the trade name Zydelig®, is a first-in-class inhibitor of PI3K delta, a protein that is highly expressed in many B-cell malignancies...

2014-07-22 08:32:59

TEL AVIV, Israel, July 22, 2014 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed"), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that the U.S. Food and Drug Administration, or the FDA, cleared Galmed's Investigational New Drug, or IND, application. Such clearance will permit Galmed to conduct clinical trials of...


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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