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Latest U.S. Food and Drug Administration Stories

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...

2014-07-21 16:26:17

SAN FRANCISCO and DUBLIN, July 21, 2014 /PRNewswire/ -- Medicines360, a non-profit women's health pharmaceutical company, and Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360's New Drug Application (NDA) for Levosert(TM) (levonorgestrel), a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy. In June 2013, Medicines360 and...

2014-07-20 23:00:20

The Firm is actively filing NaturaLyte and GranuFlo lawsuits on behalf of dialysis patients who allegedly suffered strokes, heart attacks and other cardiovascular problems after being administered the medications. New York, NY (PRWEB) July 20, 2014 Nearly 2,000 NaturaLyte and GranuFlo lawsuits (http://www.thegranuflolawsuit.com ) have now been filed in a federal litigation involving the dialysis medications, Bernstein Liebhard LLP reports. A Case List updated on July 15th indicates that...

2014-07-17 12:30:54

BRISBANE, Calif., July 17, 2014 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that pirfenidone has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). This designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant...

2014-07-15 12:29:01

"Search and Rescue" Program Piloted in Maryland and Rhode Island NEW YORK, July 15, 2014 /PRNewswire-USNewswire/ -- The Partnership for Drug-Free Kids, a nonprofit dedicated to reducing teen substance abuse and supporting families impacted by addiction, has introduced a new campaign targeting healthcare professionals as part of its Medicine Abuse Project. This education effort, supported by a multi-year grant from the U.S. Food and Drug Administration (FDA), recognizes the key role...

2014-07-14 12:25:07

Summer weather typically causes spike in incidences of food poisoning WASHINGTON, July 14, 2014 /PRNewswire-USNewswire/ -- Millions of Americans are expected to fire up the grills this summer--a time when incidents of foodborne illness, commonly known as food poisoning, tend to surge. In preparation for barbeque season, the Ad Council and the U.S. Department of Agriculture's Food Safety and Inspection Service, in partnership with the U.S. Food and Drug Administration (FDA) and the Centers for...

2014-07-10 23:07:22

Activist/filmmaker organizing National Gay Blood Drive on July 11 to show impact of changing donor ban for millions of Americans. Nationwide, United States of America (PRWEB) July 10, 2014 Since 1983, the U.S. Food and Drug Administration (FDA) has banned gay and bisexual men from donating blood. Men who have had sexual contact with men (MSM donors) are deferred by the FDA for life, and every blood bank in the U.S. is mandated to comply with this policy. Every two seconds someone in the...


Word of the Day
bibliopole
  • A bookseller; now, especially, a dealer in rare and curious books.
This word comes from a Greek phrase meaning 'book seller.'
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