its unfortunate name, antisense technology is an extremely good method for creating the sort of highly targeted compounds the FDA likes. Through antisense based drug development, Isis has become a highly efficient drug discovery machine. It is so efficient
Commissioner, U.S. Food and Drugs Administration ( FDA ) National Press Club Luncheon, October 6, 2010 ..... new systemic antibiotics approved by the U.S. Food and Drug Administration ( FDA ) has plunged from Complete Story »
continues to get clobbered, as their heart drug Vascepa has turned out to be a bust. Arena Pharmaceuticals ( ARNA ) finally got FDA approval on their obesity drug Belviq... Only no one cares. With a max 5% weight loss, sales will most likely be slow to
expected in Q4), trial 012 (top-line data expected in H2 2014), and data from a long-term integrated Phase 2 study. An FDA meeting to discuss Fabry Monotherapy's approval pathway is now expected in H2 2014. ( webcast ) Post your comment!
diamonds. In our opinion, growth in ceramic-on-ceramic hip implants will boost ceramic sales as the population ages. Rockwood is currently the only manufacturer of Food and Drug Administration -approved ceramic hip components.
clock has struck nearly 12 months since Amarin ( AMRN ) got its FDA approval for Vascepa (icosapent ethyl) capsules for the reduction ..... month AMRN fails to be granted New Chemical Entity status by the FDA . This past Friday, AMRN failed once again to be granted NCE
tyrosine kinase inhibitor targeted for advanced renal cell carcinoma. After receiving a negative review in the FDA Advisory Panel, the FDA rejected tivozanib citing concerns that although the drug had improved time to progression, the overall survival
stack up against the competition? With Erivedge ® (vismodegib), CRIS has a valuable player on its team. Vismodegib is an FDA approved drug to treat advanced basal cell carcinoma (BCC). BCC is a skin cancer that exhibits aberrant hedgehog pathway signaling
years and the increasingly strict regulatory environment will remain a significant impediment. The U.S. Food and Drug Administration have a classification system for medical devices. The classes relate to device complexity potential safety
takes the time to dig into the facts, you discover that all analyses presented by Palatin were pre-planned and approved by the FDA . Skepticism in this area is not unfounded, which makes Palatin's story that much more compelling. BioSante Pharmaceuticals