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 ...
Federal Register notice: FDA corrects a notice that appeared in the 5/20 Federal Register announcing the approval withdrawals for 21 ANDAs involving m...
FDA commissioner Robert Califf warns that FDA employees affected by user fee funds could start getting layoff notices in early September if House and ...
FDA warns consumers against using eight brands of ultraviolet wands for household disinfection due to the risk of unsafe radiation levels.