FDA News

The FDA approved Paxlovid™ for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease.

The novel co-inhibitor of sodium glucose cotransporter-1/2 proteins will be available by the end of June 2023, according to Lexicon Pharmaceuticals.

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Bayer's investigational FXIa inhibitor is currently being studied in a large-scale phase 3 development program expected to enroll more than 27 000 participants.

Brixadi is the first and only long-acting buprenorphine injectable that is available in both weekly and monthly doses.

Medical director of the NFID William Schaffner, MD, discusses the research behind the FDA's decision to approve the first-ever RSV vaccine.

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.