FDA issues Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating BCG-unresponsive non-muscle invasive b...
CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger retires to spend more time with family.
Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2022.
FDA amends the emergency use authorizations for both Pfizer-BioNTechs and Modernas Covid-19 vaccines to allow for the use of an additional dose in cer...
Ipsen withdraws its NDA palovarotene, indicated for preventing heterotropic ossification as a potential treatment for people living with fibrodysplasi...
FDA clears a Syntr Health Technologies 510(k) for the SyntrFuge System and its use in surgical specialties when the transfer of harvested adipose tiss...
A Florida federal judge sentences two people to jail time and restitution for participating in a conspiracy to falsify clinical trial data.
CDRH says it met or exceeded strategic goals in the period 2018-2020.