FDA News

The Pfizer vaccine RSVpreF administered to pregnant people was judged by the advisory committee to be effective at preventing RSV in infants from birth to 6 months.

Kelly Moore, MD, MPH, says the public health community is relieved by the FDA's approval and excited at "the chance to finally do something about the disease."

Your daily dose of clinical news you may have missed.

Fezolinetant is the first NK3 receptor antagonist approved by the FDA for treatment of moderate-to-severe vasomotor symptoms due to menopause.

Brexpiprazole, an atypical antipsychotic, is the first and only medication approved to treat AD-associated agitation, reported in almost half of people with the disease.

Opill, a progestin-only oral contraceptive, if approved by the FDA, would be the first an only form of birth control in the US available without a physician's prescription.

The novel vaccine, from biopharma company GSK, is approved to prevent RSV-associated lower respiratory tract disease in adults aged ≥60 years.

Vowst is the first and only FDA-approved orally administered microbiota-based therapeutic for the prevention of recurrent C. diff infection in adults.

The wearable tubeless insulin delivery device provides a fixed rate of continuous long-acting insulin for 72 hours, requiring no needles or injections.

The oral calcitonin gene-related peptide receptor antagonist is now indicated for prevention in both episodic and chronic migraine.