Gilead asks the Supreme Court to hear its appeal of a 9th Circuit decision on the materiality of a False Claims Act suit involving several Gilead HIV ...
Federal Register notice: FDA determines for patent extension purposes that the regulatory review period for Forest Laboratories Avycaz (ceftazidime pe...
FDA accepts for review an Aquestive Therapeutics NDA for clobazam oral soluble film for adjunctive treatment of seizures associated with Lennox-Gastau...
Three Jones Day attorneys say the 2nd Circuit Court of Appeals has joined several other appeals courts in application of the Supreme Courts rigorous m...
FDA clears a Centric Medical 510(k) for the Cannulated Screw Internal Fixation System for use in foot and ankle reconstruction procedures.
FDA issues two drug compounding definition guidances and one relating to diluting, mixing, or repackaging certain biological products.
FDA grants Lyric Pharmaceuticals a fast track designation for ulimorelin (LP101) for treating enteral feeding intolerance in critically ill patients.
FDA issues a draft guidance with recommendations on the use, content, and circumstances for issuing public warnings and notifications for recalled pro...