Federal Register notice: FDA issues an order debarring Michael Terry Little for five years from importing or offering for import any drug into the U.S...
Agios Pharmaceuticals plans to submit by the end of the year an NDA for mitapivat and its use on adults with transfusion-dependent alpha- or beta-thal...
FDA places a partial clinical hold on a Blueprint Medicines early-stage trial testing its experimental cancer drug because of safety concerns.
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.
