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Provention Bio says it is planning a rolling BLA application for its Type 1 diabetes drug teplizumab in 2020.[ Price : $8.95]
FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology dru...[ Price : $8.95]
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact oral solution ...[ Price : $8.95]
FDA clears a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant.[ Price : $8.95]
The CDER Office of Prescription Drug Promotion warns Alkermes about a misleading Vivitrol print ad that omits important risk infor...[ Price : $8.95]
FDA accepts for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients who do not ...[ Price : $8.95]
The Senate votes 91-2 to approve legislation to reform the over-the-counter drug regulatory system.[ Price : $8.95]
FDAs Cardiovascular and Renal Drug Advisory Committee votes 11-2 against recommending approval of Correvio Pharmas vernakalant for...