The FDA has approved the human interleukin (IL)-12 and -23 antagonist ustekinumab (Stelara – Janssen Biotech) for treatment of moderately to severely active Crohn's disease in adults who were intolerant of or whose disease was unresponsive to treatment with immunomodulators or corticosteroids, or a tumor necrosis factor (TNF) inhibitor. Ustekinumab was approved earlier for treatment of psoriasis and psoriatic arthritis.

The FDA has approved siponimod (Mayzent – Novartis), a sphingosine 1-phosphate (S1P) receptor modulator, for oral treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Siponimod is the second S1P receptor modulator to be approved in the US; fingolimod (Gilenya), which is approved for oral treatment of relapsing forms of MS in patients ≥10 years old, was the first. The purine antimetabolite cladribine (Mavenclad) was also...

The FDA has approved a new indication for prevention of anal cancer and anal intraepithelial neoplasia in both sexes for the human papillomavirus (HPV) vaccine Gardasil (Merck). This vaccine is already FDA-approved for prevention of cervical cancer and genital warts in females 9-26 years old and for prevention of genital warts in males 9-26 years old. HPV types 6 and 11 cause about 90% of genital warts. Types 16 and 18 cause more than 70% of cervical cancer and about 80% of anal cancer.1 Gardasil is highly effective in preventing infection with HPV types 6, 11, 16 and 18 in both males and...

The FDA has withdrawn its Emergency Use Authorization (EUA) of the investigational anti-SARS-CoV-2 monoclonal antibody bebtelovimab (LY-CoV1404 – Lilly) for treatment of COVID-19. Bebtelovimab is not expected to retain activity against the Omicron variants BQ.1 and BQ.1.1, which currently cause the majority of COVID-19 cases in all regions of the US.

Lefamulin (Xenleta – Nabriva), a semisynthetic pleuromutilin antibiotic, has been approved by the FDA for IV and oral treatment of community-acquired bacterial pneumonia (CABP) in adults. It is the first systemic pleuromutilin antibiotic to be approved in the US; retapamulin (Altabax), a 1% topical ointment for treatment of impetigo, was approved in 2007.

The Reflotron (Boehringer Mannheim), a desk-top colorimetric reflectance analyzer that weighs 12 pounds, can do clinical chemistry tests on 30 l of whole blood, plasma or serum, using multilayered strips containing dry chemicals. A single test takes two to three minutes.

Recombinant alpha interferon has been marketed in the USA for treatment of hairy-cell leukemia, genital warts, and AIDS-related Kaposi's sarcoma (Medical Letter, 28:78, 1986; 30:70, 1988). Recent reports indicate it may also be useful for treatment of chronic viral hepatitis. Recombinant alpha interferon is available as alfa-2a (Roferon-A - Roche) or alfa-2b (Intron A - Schering), which are identical except for one amino acid.

Fludarabine phosphate (Fludara - Berlex), an analog of vidarabine (Vira-A), was recently approved by the U.S. Food and Drug Administration for treatment of patients with refractory chronic lymphocytic leukemia (CLL). The drug has not yet been marketed but is still available, as it has been for two years, through the National Cancer Institute.

Flosequinan (Manoplax - Boots), a fluoroquinolone derivative, is now available in the USA for treatment of congestive heart failure. Labeling approved by the US Food and Drug Administration recommends the drug only for patients who cannot tolerate or have not responded adequately to an angiotensin-converting enzyme (ACE) inhibitor.

Nedocromil sodium (Tilade - Fisons), an anti-inflammatory drug similar to cromolyn sodium (Intal - Fisons), although chemically unrelated, is now available in the USA as a metered-dose inhaler for maintenance treatment of mild to moderate asthma.