FDA's Center for Drug Evaluation and Research refused to approve ISTA's sNDA for a larger fill size of the topical non-steroidal anti-inflammatory because it does not believe a single bottle should be used to dose drug in both eyes.

FDA tells the Oncologic Drugs Advisory Committee it will have a voting role at the two-day hearing, in contrast with CDER's original expectation that the panel would provide advice and recommendations but not vote.

Genentech has come out fighting on multiple fronts in its attempt to retain Avastin’s breast cancer indication, proposing a new confirmatory study, submitting new Phase IV data and attacking FDA’s interpretation of both the underlying scientific data and its regulations on withdrawal.