FDA Alerts

The US Food and Drug Administration has approved a new generic option for the control of serum phosphorus levels in patients with chronic kidney disease who are undergoing dialysis.

The FDA has approved a nasal antihistamine for nonprescription use in the treatment of seasonal and perennial allergic rhinitis in individuals aged 6 years and older.

The FDA has approved the first conjugate vaccine that protects against 20 Streptococcus pneumoniae serotypes in adults aged 18 years and older.

The accelerated approval pathway is used when a medication is found to provide a significant advantage over other approved treatments for serious or life-threatening conditions.

The US Food and Drug Administration has approved a drug for chronic weight management in adults with overweight or obesity and at least one weight-related condition.

The approval comes after positive results from the LIBERTY 1 and 2 studies were published, which showed safety and efficacy of the medication after 24 weeks.

In this video, Phil Lempert discusses the history of the FDA's definition of "healthy" and the use of the term on food labeling.

The US Food and Drug Administration has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents aged 12 through 15 years.

The US Food and Drug Administration have announced their approval of a higher dose of naloxone hydrochloride nasal spray for the treatment of opioid overdose.

The US Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) issued to the monoclonal antibody bamlanivimab, for the treatment of mild to moderate COVID-19.