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FDA issues Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating BCG-unresponsive n...[ Price : $8.95]
CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger retires to spend more time with family.[ Price : $8.95]
Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2022.[ Price : $8.95]
FDA amends the emergency use authorizations for both Pfizer-BioNTechs and Modernas Covid-19 vaccines to allow for the use of an ad...[ Price : $8.95]
Ipsen withdraws its NDA palovarotene, indicated for preventing heterotropic ossification as a potential treatment for people livin...[ Price : $8.95]
FDA clears a Syntr Health Technologies 510(k) for the SyntrFuge System and its use in surgical specialties when the transfer of ha...[ Price : $8.95]
A Florida federal judge sentences two people to jail time and restitution for participating in a conspiracy to falsify clinical tr...[ Price : $8.95]
CDRH says it met or exceeded strategic goals in the period 2018-2020.