A new study finds that most Tepezza patients suffer some degree of hearing loss, and a third of those may not recover their hearing.
An FDA advisory committee voted to recommend the agency not approve Copiktra for some blood cancer patients due to an increased risk of death.
The FDA has proposed new guidelines for safely including children in clinical trials.
An advisory committee is being asked to review the benefits and risks of Copiktra, a blood cancer drug FDA experts say appears to lower life expectancy in some cancer patients.
A new Chinese study found glucocorticoids are effective treatments for Stevens-Johnson Syndrome.
A federal judge has ruled that hundreds of Fosamax femur fracture lawsuits are preempted by federal law because the FDA rejected a proposed warning label change.
A case study links the glaucoma drug Neptazane with a case of Stevens-Johnson Syndrome, a serious skin reaction which can lead to severe injury, hospitalization and death.
The FDA has issued new guidance on how to speed up generic drug approval processes, amid existing concerns that the agency already approves many generic drugs too quickly and without…
A new study finds that many patients are confused by the FDA's REMS drug safety program, which adds extra requirements to drugs with potentially severe side effects.
CDC researchers report that blood thinners and insulin account for the largest number of emergency room visits due to adverse drug reactions.
