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Federal Register notice: FDA makes available a draft guidance Platform Technology Designation Program for Drug Development.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...
Researchers at Yale and Emory say they find little evidence to support the notion that surrogate markers used in non-oncologic drug accelerated approv...
