The FDA has approved rolapitant (Varubi – Tesaro), an oral substance P/neurokinin 1 (NK₁) receptor antagonist, for use with other antiemetics to prevent delayed nausea and vomiting associated with cancer chemotherapy in adults. It is the third substance P/NK₁ receptor antagonist to be approved in the US; aprepitant (Emend) and netupitant (only available in combination with the 5-HT₃ receptor antagonist palonosetron as Akynzeo) were approved earlier for prevention of both acute and delayed chemotherapy-induced nausea and vomiting.

The FDA has approved a 10% nanoemulsion gel formulation of the porphyrin-based photosensitizer aminolevulinic acid hydrochloride (ALA; Ameluz – Biofrontera) for use in combination with a narrowband red light photodynamic therapy (PDT) lamp (BF-RhodoLED) for treatment of actinic keratoses (AKs) of mild to moderate severity on the face and scalp. A 20% ALA solution (Levulan Kerastick) approved for use in combination with blue light PDT (BLU-U) has been available in the US since 2002.

The recombinant interleukin-1 (IL-1) receptor antagonist anakinra (Kineret – Sobi) has been granted an FDA Emergency Use Authorization (EUA) for treatment of hospitalized adults with confirmed COVID-19 pneumonia who require low- or high-flow supplemental oxygen, are at risk of progressing to severe respiratory failure, and are likely to have elevated plasma levels of soluble urokinase plasminogen activator receptor (suPAR). Anakinra has been available in the US for years; it is FDA-approved for multiple indications, including rheumatoid arthritis. Assays for suPAR are...

Vilazodone (Viibryd – Forest), a selective serotonin reuptake inhibitor (SSRI) and partial 5-HT_1A receptor agonist, has been approved by the FDA for treatment of depression. It has been claimed to have no sexual side effects and not to cause weight gain.

The FDA has approved darolutamide (Nubeqa – Bayer), an androgen receptor inhibitor, for oral treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC). Darolutamide is the third androgen receptor inhibitor to be approved for this indication; apalutamide (Erleada) and enzalutamide (Xtandi), which are also approved for use in patients with metastatic castration-resistant prostate cancer (mCRPC), were approved earlier.

Rotarix, an oral live-attenuated rotavirus vaccine, has been approved by the FDA for prevention of rotavirus gastroenteritis in infants and children. Rota-Shield was withdrawn from the market because of an association with intussusception. RotaTeq, an oral live, human-bovine reassortant rotavirus vaccine, is recommended by the American Academy of Pediatrics as a routine immunization.

The FDA has approved ceftazidime/avibactam (Avycaz – Actavis) for IV treatment of complicated urinary tract and intra-abdominal infections in adults who have limited or no other treatment options. Ceftolozane/tazobactam (Zerbaxa – Cubist), another cephalosporin/beta-lactamase inhibitor combination, was approved in 2014.

The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live fecal microbiota spores, for prevention of additional recurrences of Clostridioides difficile infection (CDI) in adults. Vowst is the first orally administered microbiota-based treatment to be approved for this indication. A rectally-administered live fecal microbiota-based suspension (Rebyota) was approved in 2022 for the same indication. Neither product is approved for acute treatment of CDI.

The EarCheck Middle Ear Monitor (Innovia Medical) is a device marketed to consumers for home detection of middle-ear effusion (MEE) in children.

Over-the-counter products containing melatonin are widely used as sleep aids in children and adults.