The FDA has approved Cabenuva (ViiV Healthcare), an extended-release formulation of the new integrase strand transfer inhibitor (INSTI) cabotegravir copackaged with an extended-release formulation of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine, as a once-monthly complete regimen for intramuscular (IM) treatment of adults with HIV-1 infection who are virologically suppressed (HIV-1 RNA...

The FDA has approved tenapanor (Ibsrela - Ardelyx), a sodium/hydrogen exchanger 3 (NHE3) inhibitor, for twice-daily oral treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Tenapanor is the first NHE3 inhibitor to become available in the US.

Elinzanetant (Lynkuet – Bayer), a first-in-class neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Fezolinetant (Veozah), an NK3 receptor antagonist, was approved for the same indication in 2023.

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

The FDA has approved a generic injectable formulation of the opioid antagonist nalmefene (Purdue) for the management of known or suspected opioid overdose. Revex, the reference product, was withdrawn from the market in 2008 for commercial reasons.

The FDA has approved Opill (Perrigo), a progestin-only oral contraceptive that contains norgestrel, for sale over the counter (OTC). Opill is the first oral contraceptive to be approved in the US for sale without a prescription. Approval of OTC Opill is intended to increase access to effective contraception and reduce the rate of unintended pregnancies.

The FDA has approved a 0.25% ophthalmic solution of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for treatment of Demodex blepharitis. Lotilaner is the first drug to be approved in the US for this indication.

Avmapki Fakzynja Co-Pack (Verastem), a combination of the kinase inhibitors avutometinib and defactinib, has received accelerated approval from the FDA for treatment of KRAS-mutated recurrent low-grade serous ovarian cancer in women who had previously received systemic therapy. Neither drug is approved for use as monotherapy for any indication. Avmapki Fakzynja is the first treatment to be approved in the US for this indication.

The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since 2015 for emergency treatment of opioid overdose. Generic formulations of Narcan have also been approved; the manufacturers of these products will be required to switch them to OTC status and amend their labeling accordingly. Kloxxado, an 8-mg naloxone nasal spray, remains available only by prescription.

Lecanemab-irmb (Leqembi – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The label states that treatment with Leqembi should be initiated in patients with mild cognitive impairment (MCI) or mild dementia, the population in which the drug was initiated in clinical trials. Lecanemab is the second IV amyloid-beta directed monoclonal antibody to be approved for this indication; aducanumab (Aduhelm) was approved in 2021 and has the same restrictions on treatment...