Quantcast

Latest FDA Stories

2014-06-17 08:26:35

Recently FDA Approved Qudexy(TM) XR Offers a New Treatment Option for Managing Specific Seizure Types MAPLE GROVE, Minn., June 17, 2014 /PRNewswire/ -- Results from Upsher-Smith Laboratories, Inc.'s, Phase 3 study of USL255, Qudexy(TM) XR (topiramate) extended-release capsules, a proprietary, once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile, were published in the June issue of Epilepsia, a leading, authoritative...

2014-06-16 23:12:21

On June 13, the FDA notified of a recall (Class I) of Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm because one lot was mislabeled. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 16, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Portex Low Dead Space Connector. The FDA...

2014-06-16 12:30:07

Ban of Antibacterial Soaps Could Lead to 7.5 Million Foodborne Illnesses, According to the American Cleaning Institute, Personal Care Products Council WASHINGTON, June 16, 2014 /PRNewswire-USNewswire/ -- Proposed rules by the U.S. Food and Drug Administration (FDA) could remove antibacterial soaps and body washes from store shelves - and might lead to 7.5 million new cases of foodborne illness and more than $38 billion in health care costs annually. In an effort to maintain consumer access to...

2014-06-16 12:28:52

ATLANTA, June 16, 2014 /PRNewswire/ -- Avion Pharmaceuticals, LLC, a specialty pharmaceutical company, announces positive feedback on two New Drug Applications (NDA) with projected approvals of late 2016 and early 2017. Based on the feedback from the Food and Drug Administration (FDA) Avion will be moving into Phase II/III on one NDA Program, and into Phase II on the other. In line with Avion's strategic corporate mission, both NDAs are in the women's health category. "We are very...

2014-06-16 08:29:05

First-ever Platform to Deliver Highly Accurate, Molecular Results in Under 15 Minutes WALTHAM, Mass., June 16, 2014 /PRNewswire/ -- Alere Inc. (NYSE: ALR), a leading global provider of point-of-care rapid diagnostic and health information solutions, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Alere(TM) i Influenza A & B test, the first and only molecular test to detect and differentiate influenza A and B virus in less...

2014-06-16 08:28:43

Cell-culture technology is a modern alternative to manufacture influenza vaccines without chicken eggs, with potential to rapidly respond to a pandemic[1] BASEL, Switzerland, June 16, 2014 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) licensed its manufacturing facility in Holly Springs, N.C. for the production of cell-culture influenza vaccines. This is the first US facility of its kind and is now approved for commercial production. The site will...

2014-06-16 08:28:24

Sub-study will investigate effects of MST-188 on tissue oxygenation in sickle cell disease patients experiencing a vaso-occlusive crisis SAN DIEGO, June 16, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today announced that, in line with prior guidance, it has initiated patient enrollment in a sub-study within EPIC, its pivotal phase 3 study of MST-188 in sickle cell disease, to investigate and quantify the effect of MST-188 on tissue oxygenation, which will be...

2014-06-16 04:21:39

IMPACT Dx(TM) Combined Function System Will Also Be Available in the European Union SAN DIEGO, June 16, 2014 /PRNewswire/ -- Agena Bioscience, Inc., which recently acquired the Bioscience business of Sequenom, Inc., was notified today by Sequenom, Inc. that it received premarket clearance from the U.S. Food and Drug Administration (FDA) for the IMPACT Dx(TM) Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx(TM) System. The IMPACT Dx(TM) Factor V Leiden and Factor II...

2014-06-14 23:01:01

Hot topics on Wednesday, June 18 SAN DIEGO (PRWEB) June 14, 2014 Patient perspective in clinical trials, efforts of the Food and Drug Administration (FDA) to increase the number of regulators overseas, the emerging practice of risk-based monitoring in clinical trials, and challenges in orphan drug regulation will be discussed Wednesday, June 18, at the DIA 2014 50th Annual Meeting at the San Diego Convention Center. Patient Perspective to Drive Enrollment in Clinical Trials “The...

2014-06-13 23:07:04

On June 11, the FDA announced that all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots, by Diabetic Supply of Suncoast Inc., are recalled due to labeling error. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) June 13, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for Blood...


Word of the Day
callithump
  • A somewhat riotous parade, accompanied with the blowing of tin horns, and other discordant noises; also, a burlesque serenade; a charivari.
'Callithump' is a back-formation of 'callithumpian,' a 'fanciful formation' according to the Oxford English Dictionary. However, the English Dialect Dictionary, says 'Gallithumpians' is a Dorset and Devon word from the 1790s that refers to 'a society of radical social reformers' or 'noisy disturbers of elections and meetings.'
Related