FDA extends by three months its review of a Regeneron supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult pa...
Federal Register final rule: FDA issues a regulation to implement its authority to destroy a device valued at $2,500 or less that has been refused adm...
Gilead Sciences says it will be discussing with FDA a failed confirmatory study of accelerated-approval Trodelvy (sacituzumab govitecan-hziy) in patie...
An FDA advisory committee briefing document reveals reviewer concerns about safety and efficacy issues in a Lykos Therapeutics NDA for midomafetamine ...
FDA approves a Moderna BLA for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus vaccine for adults aged 60 years and older.
FDA approves an Avita Medical PMA supplement for the Recell GO System, its next-generation autologous cell harvesting device.
Federal Register notice: FDA makes available a draft guidance Platform Technology Designation Program for Drug Development.
Federal Register notice: FDA decides to terminate the Science Advisory Board to the National Center for Toxicological Research because it has become o...
