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CDER associate director for biosimilars Leah Christl says biosimilar product developers have essentially ignored FDAs abbreviated ...[ Price : $8.95]
Roxane tells FDA it should deny Jazz Pharmaceuticals latest citizen petition seeking to delay review of any ANDAs for generic Xyre...[ Price : $8.95]
AdvaMed praises a call by 18 senators for a delay in implementation of the upcoming medical device tax.[ Price : $8.95]
FDA denies a Merck petition asking that it not accept ANDAs for generic Nasonex.[ Price : $8.95]
FDA awards Eisai an additional six months marketing exclusivity for Aciphex for meeting criteria under the agencys pediatric exclu...[ Price : $8.95]
FDA warns MedArt about Medical Device Reporting and Quality System violations found in an inspection at a company manufacturing fa...[ Price : $8.95]
An FDA advisory committee votes 2 to 11 against recommending approval for Zogenix pure hydrocodone pain medication Zohydro ER due ...[ Price : $8.95]
Genentech reports that a Phase 3 study shows that Perjeta, Herceptin, and docetaxel extended survival in HER2-positive breast canc...