The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.

Polatuzumab vedotin-piiq (Polivy – Genentech), a CD79b-directed antibody and microtubule inhibitor conjugate, has been approved by the FDA for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for first-line treatment of diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) in adults who have an International Prognostic Index (IPI) score ≥2. The drug was previously approved for use in combination with bendamustine and rituximab for treatment of patients with relapsed or refactory DLBCL,...

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Rates of meningococcal disease are highest in infancy, but until recently no meningococcal vaccine was approved for use in this age group. MenHibrix (GSK), a new conjugate vaccine that protects against Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib), has been approved by the FDA for use in infants ≥6 weeks old and Menveo, a meningococcal vaccine already approved for patients ≥2 years old that protects against serogroups A, C, Y, and W-135, is now approved for use in infants ≥2 months old.SEROGROUPS — Five major serogroups of N. meningitidis, A, B, C,...

Mirvetuximab soravtansine-gynx (Elahere – Immuno-Gen), an antibody-drug conjugate, has received accelerated approval by the FDA for treatment of folate receptor (FR) alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy. Accelerated approval was based on the overall response rate and median duration of response.

The FDA has licensed Penbraya (Pfizer), a pentavalent polysaccharide conjugate meningococcal vaccine, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penbraya is the only meningococcal vaccine that contains all five of these serogroups. Two quadrivalent polysaccharide conjugate meningococcal vaccines containing serogroups A, C, W, and Y (MenACWY; Menveo, MenQuadfi) and two meningococcal serogroup B vaccines (MenB; Bexsero, Trumenba) are available in the US (see Table...

Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5 or below, T-scores between -1.0 and -2.5 with a history of fragility (low-trauma) fracture of the hip or spine, or T-scores between -1.0 and -2.5 with a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture.

Increased resistance of pneumococci to antimicrobial drugs may encourage more extensive use of pneumococcal polysaccharide vaccine.

Pegademase (Adagen - Enzon), bovine adenosine deaminase (ADA) conjugated with polyethylene glycol (PEG), was recently approved by the US Food and Drug Administration as an 'orphan drug' for treatment of severe combined immunodeficiency disease (SCID). SCID due to inherited deficiency of ADA occurs in less than one per million births; until recently, without extraordinary isolation measures, it was usually fatal before the age of two.

Indium 111 In-satumomab pendetide (CYT-103, OncoScint CR/OV Kit - Cytogen), a new intravenous imaging agent, has been approved by the US Food and Drug Administration for detection of extrahepatic spread of colorectal and ovarian tumors.