FDA News and Regulatory Updates

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.

KidneyIntelX.dkd, a first-in-class AI-enabled prognostic test, stratifies risk of DKD progression in 5 years and is specific for early stage disease.

The 2 new vaccines are authorized for adults aged 60 years and older and with CDC Director Walensky's final nod, should be available this fall.

The 2 SGLT-2 inhibitor-based medications are the first in the class to be approved for pediatric T2D and provide a much needed additional oral treatment option for the population.

Colchicine 0.5 mg is associated with reduction in a wide range of CV events in patients already on statin therapy, supporting the long-held "anti-inflammatory" hypothesis.

The FDA's VRBPAC members were unanimous in their recommendation that the 2023-24 COVID vaccines reflect the dominant strain in circulation, XBB.

The FDA advisory committee will review all current surveillance data and recommend which strain/s to include in updated COVID-19 vaccines for the 2023-2024 vaccination campaign.

Nirsevimab, a long-acting monoclonal antibody, if approved, will be indicated to prevent RSV LRTD in neonates and infants born during or entering into their first RSV season.

Proposed indications for the investigational factor XIa inhibitor are: stroke prevention after acute ischemic stroke or high-risk transient ischemic attack; recent acute coronary syndrome; and atrial fibrillation.

Compounded versions of semaglutide, often sold online, may contain salt versions of the molecule and are not evaluated by the FDA for safety or efficacy.

The FDA's decision was based on data from the pivotal phase 3 RENOIR trial, which demonstrated the efficacy, immunogenicity, and safety of Abrysvo in adults aged ≥60 years.

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."

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