A CDER Webinar explains updates to forms FDA-3542a and 3542 and instructs participants on how to complete the forms.
FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology drugs.
The Senate confirms Stephen Hahn as the next FDA commissioner on a floor vote of 72-18.
FDA authorizes the de novo marketing of PerkinElmers GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystroph...
FDA approves an Elite Pharmaceuticals ANDA for a generic version of Shires Adderall XR, indicated for treating attention deficit hyperactivity disorde...
The House approves drug pricing legislation that is likely to die in the Senate or face a presidential veto.
Provention Bio says it is planning a rolling BLA application for its Type 1 diabetes drug teplizumab in 2020.
FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology drugs.