King & Spalding attorneys explain the three latest FDA documents issued for the software precertification program.
FDA Anesthetic and Analgesic Drugs Advisory Committee chairman Raeford Brown says agency officials have not learned anything from the opioid crisis an...
FDA approves an Amerigen Pharmaceuticals ANDA for a generic version of Shires Adderall XR (5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg).
FDA approves Sanofi Pasteurs 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to include children age 6 through 35 months.
FDA puts a partial clinical hold on Advaxis Phase 3 trial of AXAL for cervical cancer.
FDA approves a Teligent ANDA for a generic copy of Fougera Pharmaceuticals Temovate (clobetasol propionate ointment USP) 0.05%.
AdvaMed proposes legislation to allow FDA to continue to collect user fees and review medical device applications associated with those fees during an...
The Supreme Court refuses to reinstate Hellsins Aloxi patent, supporting Tevas launch of a generic form of the anti-nausea drug last year.