… 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 …