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CBER says its online submission system was compromised 10/15 and user information was obtained by the unidentified hacker.[ Price : $8.95]
FDA releases results of its survey of 11 surgeons on their experiences using the da Vinci Surgical System.[ Price : $8.95]
FDA approves a Discovery Laboratories IND for Aerosurf, allowing the company to launch a Phase 2 clinical trial program.[ Price : $8.95]
FDA releases an FDA-483 from an inspection at Burzynski Research Institute.[ Price : $8.95]
FDA gives the Medicines Co. a Qualified Infectious Disease Product designation for oritavancin and its use in treating acute bacte...[ Price : $8.95]
FDA tells Sarepta Therapeutics that its planned NDA filing is premature for eteplirsen and its use in treating Duchenne muscular d...[ Price : $8.95]
A Phase 3B/4 study involving Pfizers Rapamune in kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) t...[ Price : $8.95]
FDA grants Alnylam Pharmaceuticals a fast track designation for ALN-TTR02 (patisiran) for treating transthyretin-familial amyloid ...