FDA publishes two draft guidances to help give medication information to pregnant and lactating women so they may make informed decisions about their ...
FDA releases the establishment inspection report from a 2018 inspection at Immunomedics.
HHS finalizes a rule requiring prescription drug list prices in TV ads for many of the drugs.
Bloomberg Technology reports that Johnson & Johnson is paying $1 billion to resolve most of 6,000 suits involving its Pinnacle metal-on-metal hip impl...
Three stakeholders comment on an updated FDA guidance on nonproprietary naming of biological products.
The House passes two bipartisan bills that would make updates to FDAs Orange Book and Purple Book to improve accuracy and transparency of the two data...
FDA clears two CryoConcepts 510(k)s for two cryosurgical devices for physicians.
FDA clears a BioCardia 510(k) for the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart.