Takeda says it is moving its narcolepsy Type 1 drug TAK-861 to a Phase 3 trial after reporting positive results from a Phase 2b trial.
FDA clears a Kenota Health 510(k) for its Kenota 1 Total IgE [immunoglobulin E] test system.
Federal Register notice: FDA debars Shanif Abdul Punjani for five years from importing or offering for import any drug into the U.S.
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.
