FDA approves Janssens Stelara (ustekinumab) for treating pediatric patients six years of age and older with active psoriatic arthritis.
AstraZeneca says discontinued a monalizumab study after a planned futility interim analysis of the INTERLINK-1 Phase 3 study did not meet a pre-define...
FDA posts a final guidance entitled Changes to Disposable Manufacturing Materials: Questions and Answers.
Law firm Sidley draws attention to a recent southern Florida federal court dismissal of a whistleblower lawsuit that declined to embrace the arguments...
FDA grants Omeros an orphan drug designation for OMS906 and its use in treating paroxysmal nocturnal hemoglobinuria (PNH).
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Acceleron Pharmas Reblozyl (luspatercept-aamt)....
FDA clears a Siemens Healthineers 510(k) for the ARTIS icono ceiling, a ceiling-mounted angiography system designed for routine and advanced procedure...
Kleinfeld, Kaplan & Becker attorney Samantha Hong urges companies/marketers to evaluate and update their advertising and marketing practices to be in ...
