The recent terrorist attacks on the US have led to many questions about the clinical effects, prevention and treatment of injury caused by chemical warfare agents.

The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based vaccine manufactured by Johnson & Johnson/Janssen to include administration of a booster dose in select populations after primary immunization with either the same COVID-19 vaccine or a different one.

The FDA has required a new warning in the label of the oral selective neurokinin 3 (NK3) receptor antagonist fezolinetant (Veozah) about the risk of hepatoxicity. The label of fezolinetant, which was approved by the FDA in 2023 for treatment of moderate to severe vasomotor symptoms due to menopause, already contained a warning about hepatic transaminase elevations associated with use of the drug.

Antiretroviral therapy is recommended for all HIV-infected patients, both to reduce the risk of disease progression and to prevent transmission of the virus to others. Various guidelines for treatment of HIV infection are available.

Two new fixed-dose combinations are now available for management of type 2 diabetes. Metaglip (Bristol-Myers Squibb), a combination of metformin and glipizide, is approved for initial therapy or as second-line treatment when control is not adequate on metformin or a sulfonylurea alone. Avandamet (GlaxoSmithKline), a combination of metformin and rosiglitazone, is approved by the FDA only as second-line therapy for patients who are not well controlled on metformin alone, or are already taking both metformin and rosiglitazone. Glucovance (Bristol-Myers Squibb), a combination of metformin and...

Azacitidine (Vidaza - Pharmion), a pyrimidine nucleoside analog of cytidine, is the first drug approved by the FDA for treatment of myelodysplastic syndrome (MDS). Azacitidine is incorporated into newly synthesized DNA and inhibits DNA methyltransferase. Hypomethylation of DNA can restore the normal expression of genes critical for cell differentiation.

Duetact (Takeda), a new fixed-dose combination of the thiazolidinedione pioglitazone (Actos) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved as an adjunct to diet and exercise to improve glycemic control in patients already taking pioglitazone and/or a sulfonylurea. Avandaryl, a combination of glimepiride and the thiazolidinedione rosiglitazone, was approved in 2006.

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.

Treatment options for snoring and obstructive sleep apnea (OSA) now include, in addition to lifestyle remedies such as weight loss and avoidance of alcohol in the evening, mechanical devices, injection of botulinum toxin into the soft palate and a variety of ENT surgical outpatient procedures. Palatal implants (Pillar procedure - Restore Medical Inc) have been approved by the FDA for treatment of snoring and OSA.