FDA News

The addition of ileus as a potential adverse event associated with the GLP-1 mimetic is not the first required for the class by the regulator.

The US Food and Drug Administration granted BTD to pegozafermin for the treatment of patients with NASH.

Empagliflozin is approved to lower the risk of sustained decline in eGFR, end-stage kidney disease, CV death, and hospitalization in adults with CKD at risk of progression.

Resmetirom, a once-daily oral, thyroid hormone receptor (THR)-β selective agonist, targets key underlying NASH pathophysiology in the liver.

As COVID-19 hospitalizations increase at the opening of the respiratory virus season, the first "seasonal" vaccine against the virus is ready for roll-out, says the FDA.

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The FDA approved Abrysvo for use in pregnant individuals to prevent LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.

The US FDA approved zuranolone 50 mg as the first oral, once-daily treatment for postpartum depression in adults.

RiVive™ nasal spray is the second nonprescription naloxone product approved by the FDA for the emergency treatment of opioid overdose.

FDA approval of the monoclonal antibody against RSV follows the unanimous vote from the agency's Antimicrobial Drugs Advisory Committee.