Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that its investigational product candidate MYDICAR® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the...
MIM Software Inc., a leading global provider of medical imaging software, announced today that Mobile MIM™ has received its second FDA 510(k) clearance for the release of its new version, Mobile MIM 3.0. Mobile MIM is now cleared for diagnostic X-ray and ultrasound viewing, as well as radiation...
It is illegal to sell unapproved diet products that make unsupported claims, the FDA (Food and Drug Administration) has warned seven companies which are selling "homeopathic HCG weight-loss drugs. The marketers of these products tell users to follow an extremely restricted and potentially...
The Food and Drug Administration is considering whether to allow over-the-counter sales of Plan B, the morning-after birth control pill. Over-the-counter sales would let women purchase emergency contraception in more locations—drugstores, supermarkets—without regard to restricted pharmacy hours...
If you were looking to start a new birth control pill in or around 2008, your OB-GYN probably suggested Yaz, by*Bayer, which was that year's most popular pill. If, in 2011, you're still on it, you may soon be seeing new warning labels, courtesy of the FDA, who are meeting this week to revisit...
Just in time for holiday parties? A fancy new 'hangover cure' with the Food and Drug Administration's stamp of approval. The remedy, an over-the-counter cocktail of aspirin and caffeine that you dissolve in water and take after a night of drinking, sells for*$2.99 for a single dose or $11.99 a...
Translational Sciences Corporation (TSC) announced that it has received FDA 510(k) clearance for commercialization of its OncoTrac™ medical imaging software. OncoTrac™ is designed for efficient quantitative assessment of treatment response of metastatic tumors including breast, lung, colorectal...
The U.S. Food and Drug Administration today issued a draft guidance aimed at fostering early-stage development of medical devices within the United States. Doing early-stage development is important to help stimulate U.S.-based innovation and contribute to medical research. The guidance...
The Food and Drug Administration has licensed HEMACORD™ (Hematopoietic Progenitor Cells-Cord, HPC-C) for allogeneic hematopoietic (blood-forming) stem cell transplantation, the first such approval of a stem cell product in the world. According to the Food and Drug Administration's notification...
The possibility of FDA regulation of tobacco products has been an ongoing topic since at least the early 1990s. Why do some think the FDA should regulate tobacco products, and what have been some of the issues that complicate how they might do this?
Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy. This marks the...
Too often, people think of the U.S. Food and Drug Administration (FDA) as a huge wall of regulations and don't consider there's an open door in that wall, drug safety scientist Sheila Weiss Smith said Sept. 16 at "Inside the FDA," a panel critique of one of America's most pervasive and often...
Pharmaceutics International, Inc. (Pii), a leading contract development and manufacturing organization, today announced it has successfully completed the first-ever US-based joint European Medicines Agency (EMA) and Food and Drug Administration (FDA) inspection. "Our entire team is very proud...
The drug vemurafenib (Zelboraf) for metastatic melanoma in patients who test positive for the BRAF mutation, has been approved by the U.S. Food and Drug Administration. Vemurafenib, a BRAF-inhibitor, is a personalized investigational drug designed to specifically inhibit the activity of the...
MedShape Solutions, Inc., the industry leader in innovative shape memory orthopedic devices, announced its new DynaNail™ Intramedullary Ankle Fusion Nail. Ankle fusion is performed to relieve pain in patients with severely degenerative ankle joints, to correct joint deformities or to revise...