The FDA said it has begun publishing reports of adverse events concerning drugs on a daily basis, instead of quarterly, as it ...

The FDA will now publish adverse event data from FAERS on a daily basis, marking a major step toward greater transparency in drug development.

The FDA’s accelerated approval of Modeyso for diffuse midline glioma with an H3 K27M mutation sets the stage for more ...

The FDA has started reporting real-time data about adverse events through the FDA Adverse Event Reporting System, improving ...

The FDA now provides daily updates on adverse event reports for drugs and biologics via FAERS. Read more here.

The accelerated approval of Modeyso for diffuse midline glioma with an H3 K27M mutation, is a step in the right direction but ...

Recent data indicate that FDA's median time between application submission and approval letter for priority review drugs is just over 8 months, accounting for the filing period.

Axogen (AXGN) announced that the U.S. FDA has extended the Prescription Drug User Fee Act goal date for its Biologics License Application for ...

The FDA urged consumers not to use the foam-style products because they may not be effective in protecting the skin from the ...

The FDA has extended the review for the BLA for clemidsogene lanparvovec for the treatment of MPSII, also known as Hunter Syndrome.

The FDA is warning consumers not to eat certain lots of Great Value frozen raw shrimp sold at Walmart due to possible ...