Amarin Announces FDA Acceptance for Filing of AMR101 NDA
BEDMINSTER, N.J. and DUBLIN, Ireland -- Amarin Corporation plc , a late-stage biopharmaceutical company focused on cardiovascular disease, today announced that its New Drug Application (NDA) for AMR101 ...

Why The FDA's Rejection Of Avastin Is Good For Medical Innovation
FDA Commissioner Margaret Hamburg The Food and Drug Administration has decided to revoke the approval of the cancer drug Avastin to treat metastatic breast cancer after a lengthy procedural battle with the drug's maker, Roche. Will that decision hurt the drug industry? Far from it. Avastin was approved for metastatic breast cancer [...]

FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals
The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.