More than 250 Democrat members of the House and Senate petition the 5th Circuit Court of Appeals to overturn a Texas federal court decision banning th...
FDA leaves a five-item Form FDA-483 after a 2/27-3/7 inspection of Rentschler Biopharmas manufacturing facility in Baden-Wurttemberg, Germany.
Rejected by FDA for accelerated approval, Lilly says it will seek the fastest traditional approval possible for its donanemab to treat early symptomat...
FDA approves a GlaxoSmithKline BLA for Arexvy (respiratory syncytial virus vaccine, adjuvanted), for preventing lower respiratory tract disease caused...
FDA publishes the International Council for Harmonization Q9(R1) foundational quality risk management guidance.
Federal Register notice: FDA corrects a 4/24 notice entitled Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing A...
FDA publishes a guidance on its assessment of user fees under PDUFA 7.
Reps. Trahan and Crenshaw challenge FDAs ability to timely approve new preventive and therapeutic products to counter new Covid-19 variants.
