April 17 (Reuters) - The U.S. Food and Drug Administration warned that a common surgical procedure used to remove uterine fibroids could spread undetected uterine cancer.
The FDA approves Glaxo ( GSK ) and Genmab's ( OTC:GNMSF ) monoclonal antibody Arzerra (ofatumumab) as a first-line therapy for
The FDA clears Merck's ( MRK +0.5% ) sublingual Ragwitek to treat short ragweed ..... s immunotherapy treatment for allergies to five types of grass pollen. The FDA approved the company's complementary product, Grastek, a few days ago
Syneron Medical Ltd., ( ELOS ) FDA Clearance of the UltraShape System Conference Call April 17, 2014, 8:30 AM ET Executives Zack Kubow – Investor Relations The Ruth Group
April 17 (Reuters) - The U.S. Food and Drug Administration warned that a surgical procedure used to mince uterine fibroids and remove them through a tiny abdominal incision could spread cancer tissue beyond the uterus in women with undetected uterine cancer.
April 17 (Reuters) - The U.S. Food and Drug Administration is requiring labels of all long-acting opioids to say they should be used strictly for patients in severe pain, a response to surging overdoses and deaths each year from the widely used pain medicines.
an endovascular stent graft for the repair of an abdominal aortic aneurysm. It received CE Mark approval in August 2010 and FDA approval in October 2012. Commercial sales began in the U.S. in November 2012. Revenues for 2012 and 2013 were $5.4M
pregnancy in women who use a transdermal patch as a method of contraception. According to IMS Health, Mylan has 300 ANDAs pending FDA approval representing $104.5B in branded sales. 42 are first-to-file submissions representing over $25B in branded sales
lead to more volatile results. Many of Crown's cans are lined with bisphenol A. Although the U.S. Food and Drug Administration currently allows BPA in food packaging, there have been growing concerns about the substance's impact
and cardiovascular problems. Over the past 12 months, 50 complaints were filed with the FDA which matches the total for the previous five years. The FDA is poised to regulate the $2B industry which some observers believe will overtake tobacco