The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for...

The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast is the first topical PDE4 inhibitor to be approved by the FDA for this indication; crisaborole (Eucrisa), another topical PDE4 inhibitor, is approved for treatment of atopic dermatitis. Oral roflumilast (Daliresp) is approved for treatment of chronic obstructive pulmonary disease.

The FDA has approved deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is the first selective TYK2 inhibitor to be approved in the US for any indication.

Bellafill (Suneva), a dermal filler approved earlier for correction of nasolabial folds, has now also been approved by the FDA for correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in adults ≥21 years old. It is the only dermal filler approved in the US for correction of facial acne scars.

Cefditoren pivoxil (Spectracef — TAP), a new oral third-generation cephalosporin, has been approved by the FDA for treatment of acute exacerbations of chronic bronchitis, pharyngitis, tonsillitis and uncomplicated skin and soft tissue infections in adults and children 12 or more years old. The drug has been used in Japan for 7 years.

Monitoring adherence of psychiatric patients to oral medication may be especially difficult. The FDA has approved Abilify MyCite (Otsuka/Proteus), an aripiprazole tablet with an embedded sensor that tracks when patients take the medication. It is indicated for treatment of adults with schizophrenia, bipolar disorder, or major depressive disorder. Abilify MyCite is the first drug with a digital ingestion tracking system to be approved in the US.

Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA for treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults. Accelerated approval of the drug was based on the response rate and duration of response. Retifanlimab is the third drug to be approved in the US for treatment of MCC; pembrolizumab (Keytruda), a PD-1 blocking antibody, is approved for the same indication as retifanlimab in patients ≥12 years old and avelumab (Bavencio), a programmed death...

Piperacillin/tazobactam (Zosyn - Lederle), an antibiotic combination product, has been approved by the US Food and Drug Administration for intravenous treatment of intra-abdominal, pelvic, skin, and skin-structure infections and for community-acquired pneumonia of moderate severity.

Vorinostat (Zolinza - Merck), an oral histone deacetylase (HDAC) inhibitor, has received accelerated approval from the FDA for treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that is persistent, progressive or recurrent after two systemic therapies. The most common types of CTCL are mycosis fungoides and SΘzary syndrome, the leukemic form of mycosis fungoides.

The FDA has approved ThermaClear (Therative), a battery-powered, handheld device, to treat individual acne lesions with heat. ThermaClear is indicated only for use on mild to moderate inflammatory acne, not severe nodular or severe cystic acne, and it is not meant to be used on blackheads and whiteheads. Two similar devices are already on the market: Zeno, another handheld device that delivers heat to acne lesions, and the Radiancy Clear Touch Lite Acne Clearance System, a larger heat-delivery device.