FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology drugs.
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact oral solution and separately for a...
FDA clears a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant.
The CDER Office of Prescription Drug Promotion warns Alkermes about a misleading Vivitrol print ad that omits important risk information.
FDA accepts for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients who do not respond well to intr...
The Senate votes 91-2 to approve legislation to reform the over-the-counter drug regulatory system.
FDAs Cardiovascular and Renal Drug Advisory Committee votes 11-2 against recommending approval of Correvio Pharmas vernakalant for use to rapidly conv...
FDA clears an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition.