The FDA has approved omidubicel-onlv (Omisirge – Gamida Cell), a nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from cord blood, to reduce the time to neutrophil recovery and the risk of infection in patients ≥12 years old with hematologic malignancies who will undergo umbilical cord blood transplantation following myeloablative conditioning therapy. Hematopoietic progenitor cell (HPC) umbilical cord products (e.g., Allocord, Clevecord, Ducord) have been available in the US for years for the same indication. Cord blood banks also supply cord...

The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults.Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

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 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.

This article includes recommendations for management of most sexually transmitted infections (STIs) other than HIV and viral hepatitis. Some of the indications and dosages recommended here have not been approved by the FDA (see Table 1).

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupilumab is the first biologic drug to be approved in the US for this indication. It has been available for years for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

Mepolizumab (Nucala – GSK), a subcutaneously injected interleukin-5 (IL-5) antagonist, has been approved by the FDA for add-on maintenance treatment of adults who have inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. Mepolizumab is also approved for treatment of asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

Irritable bowel syndrome (IBS) is a common disorder characterized by recurrent abdominal pain and altered bowel habits, often accompanied by bloating. IBS is classified by its predominant bowel symptom: constipation (IBS-C), diarrhea (IBS-D), mixed type (IBS-M), or unclassified (IBS-U). Since the exact cause of IBS is unknown, the goal of treatment is symptom control. Some over-the-counter (OTC) products and prescription drugs for IBS are listed in Tables 1-4. The safety of these drugs during pregnancy and lactation is described in Table 5 (online only).