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.
Two major drug trade associations comment on an FDA draft guidance on external controls in drug and biologic clinical trials.
FDA clears a Nano-X Imaging 510(k) for its Nanox ARC, a stationary X-ray system intended to produce tomographic images of the human musculoskeletal sy...
