FDA Alerts

After a multinational, double-blind trial showed positive results, the FDA approved a new indication for an already-approved antibacterial drug.

The FDA has cleared new tests for the detection of antibodies to the Zika virus and the detection of chlamydia- and gonorrhea-causing bacteria from throat and rectum samples.

The US Food and Drug Administration has granted approval to a foam treatment for plaque psoriasis in adolescents.

After a single trial of 38 pediatric patients showed promise, the FDA gave this treatment priority review in the approval process.

Several common active ingredients found in sunscreens exceed the maximal thresholds for systemic absorption established by the FDA, according to a new study.

The FDA has approved the first vaccine approved in the US for the prevention of dengue disease caused by all 4 serotypes of dengue virus in patients aged 9 through 16 years with laboratory-confirmed...

The FDA has approved a new option for the treatment of all 6 genotypes of hepatitis C virus in children aged 12 to 17 years.

After the clinical trial showed positive results, the first treatment option for children with systemic lupus erythematosus has been approved.

The FDA has expanded the indication of a proprotein convertase subtilisin/kexin type 9 inhibitor to include the reduction of risk for myocardial infarction, stroke, and unstable angina requiring...

The FDA has approved a second biosimilar to etanercept for the treatment of various autoimmune conditions.