FDA/CDC
FDA/CDC
FDA approves diagnostic device for autism spectrum disorder
During a study, the device made an accurate ASD determination in 98.4% of patients with the condition and in 78.9% of patients without the...
FDA/CDC
CDC: New botulism guidelines focus on mass casualty events
The new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”
FDA/CDC
FDA okays new drug option for schizophrenia, bipolar I disorder
The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies.
News
First drug for lung cancer with KRAS mutation gains FDA approval
FDA/CDC
FDA panel endorses teplizumab for delaying type 1 diabetes
Teplizumab interferes with T cell–mediated autoimmune destruction of pancreatic beta cells.
FDA/CDC
FDA fast tracks testing of schizophrenia drug for impaired cognition
The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial.
FDA/CDC
FDA restricts obeticholic acid (Ocaliva) over serious liver injury risk
Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis.
FDA/CDC
AHA reassures myocarditis rare after COVID vaccination, benefits overwhelm risks
As CDC investigates rare, mostly mild cases of myocarditis in adolescents and young adults given the Pfizer or Moderna vaccine, AHA emphasizes...
FDA/CDC
FDA approves new treatment option for rare anemia
Pegcetacoplan (Empaveli) was approved as a treatment for paroxysmal nocturnal hemoglobinuria (PNH).
Latest News
FDA preparing an environmental impact statement for 2 sunscreen ingredients
“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including...