FDA News

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.

Howard Fillit, MD, cofounder/chief scientific officer of the Alzheimer Drug Discovery Foundation, says lecenumab's approval opens the door for future drug development.

The US FDA approved norgestrel as the first daily oral contraceptive to be available over the counter, without a prescription.

The expanded indication widens the patient population eligible for the novel siRNA therapy to include high-risk patients on maximum statin Rx who have not had a CV event.

FDA's action, based on confirmatory evidence showing slowed disease progression, follows a January 2023 accelerated approval.