Quantcast

Latest FDA Stories

2014-07-28 12:28:51

Approval based on Phase 3 RESONATE data with statistically significant improvements in progression-free and overall survival HORSHAM, Pa., July 28, 2014 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICA(®) (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.[1] The FDA also approved IMBRUVICA for CLL patients with del...

2014-07-28 04:21:34

HILDEN, Germany and LONDON, July 28, 2014 /PRNewswire/ -- - Collaboration aims to create and commercialize companion diagnostic using genomic data from plasma samples to guide the use of IRESSA for non-small cell lung cancer patients - New blood test will build on QIAGEN's FDA-approved therascreen EGFR test and is planned to run on Rotor-Gene Q, member of the QIAsymphony family of automated instruments -...

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...

2014-07-26 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...

2014-07-25 23:05:40

ZeptoMetrix™ Corporation (ZMC), launches a new FDA Class 1 exempt, in vitro diagnostic, CE marked, unassayed external run control intended for use with multiplexed, respiratory molecular assays. The NATtrol™ RP Multimarker Controls - MDZ001 has been specifically designed for routine and repetitive laboratory use to monitor daily test variation, lot-to-lot test kit performance, individual operator variation and may also provide assistance in identifying increases in random or systematic...

2014-07-25 23:01:49

The Firm is representing hundreds of women who allegedly suffered serious vaginal mesh complications due to products manufactured by American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, Inc. and Ethicon, Inc. New York, New York (PRWEB) July 25, 2014 As thousands of transvaginal mesh lawsuits (http://www.transvaginalmeshlawsuithelp.com/) move forward in U.S. courts, Bernstein Liebhard LLP notes that the Food & Drug Administration (FDA) has rejected a petition by the...

2014-07-25 23:01:34

On July 21, the FDA informed that one lot of Ibuprofen and one lot of Oxcarbazepine Tablets, by American Health Packaging (AHP), are recalled due to mislabeled packaging. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 25, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Ibuprofen and Oxcarbazepine...

2014-07-24 23:11:58

On July 19, healthcare professionals and consumers were notified not to use drugs marketed as sterile produced by Downing Labs LLC, aka NuVision Pharmacy, as they may be contaminated. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) July 24, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Sterile Drug...

2014-07-24 23:11:28

Get five days of hands-on, interactive training at FDA Compliance Bootcamp 2014. The course instructors have trained the FDA's own investigators and some are former FDA investigators themselves. Falls Church, VA (PRWEB) July 24, 2014 FDA Compliance Boot Camp 2014: Validation, Data Security, Quality Risk Management and Compliance Training Oct. 20-24, 2014 – Frederick, MD http://www.fdanews.com/FDABootcamp Imagine getting inside the head of a working FDA inspector and receiving the...

2014-07-24 12:27:20

FDA-Approved CPR RsQ Assist® Makes It Easier for Anyone to Perform Hands-Only CPR CUDAHY, Wis., July 24, 2014 /PRNewswire/ -- Emergency Medical Products (EMP), a leading distributor of emergency medical equipment and supplies, announced the addition of CPR RsQ Assist® to its growing line of medical supplies and equipment. Photo - http://photos.prnewswire.com/prnh/20140723/130026 CPR RsQ Assist® is a first-of-its-kind, FDA-approved hands-only chest compression device designed...


Word of the Day
holluschickie
  • A 'bachelor seal'; a young male seal which is prevented from mating by its herd's older males (mated bulls defending their territory).
This comes from the Russian word for 'bachelors.'
Related