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.
The bladder cancer drug Padcev is linked to potentially deadly skin irritation reactions, according to FDA researchers, who now require the drug carry a black box warning.
Federal health regulators have rejected an application filed by Acadia Pharmaceuticals to expand the use of its blockbuster antipsychotic drug, Nuplazid, highlighting concerns that the medication may not be effective…
A new study reveals that Fosamax and similar osteoporosis drugs failed to provide any benefits in preventing hip fractures after seven years of use.
Thorazine and similar psychotropic drugs significantly increase the risk of tardive dyskinesia among the mentally ill, according to the findings of a new study.
The FDA has approved the use of a drug combination of Opdivo and Yervoy as a first-line treatment for mesothelioma.