Human Drugs
Lillys Lyumjev OKd for Insulin Pump
FDA approves Eli Lillys rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL for administration by continuous subcutaneous insuli...
FDA General
Former FDA Head Hahn Urges FDA Independence
Former Trump administration FDA commissioner Stephen Hahn urges more independence for the agency to prevent political interference.
Federal Register
Latest Federal Register Notices
FDA Review has posted the Federal Register notices for the week ending 8/13/2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
CDERs Ellis Unger Retiring After 24 Years at Agency
CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger retires to spend more time with family.
Federal Register
Drug User Fee Rates for FY 2022
Federal Register notice: FDA sets the rates for prescription drug user fees for fiscal year 2022.
Biologics
Pfizer, Moderna Booster Authorized for Immunocompromised
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...
Human Drugs
Ipsen Withdraws NDA Palovarotene for More Analyses
Ipsen withdraws its NDA palovarotene, indicated for preventing heterotropic ossification as a potential treatment for people living with fibrodysplasi...
Medical Devices
SyntrFuge System Cleared for Adipose Tissue
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...
Human Drugs
FDA Sends Sesen Bio a Complete Response Letter
FDA issues Sesen Bio a complete response letter on its BLA for Vicineum (oportuzumab monatox-qqrs) for treating BCG-unresponsive non-muscle invasive b...
