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...

A drug that combines the neutral sulfate salts of dextroamphetamine and racemic amphetamine with the dextro isomer of amphetamine saccharate and d,l amphetamine aspartate (Adderall - Richwood Pharmaceutical) has recently been promoted for treatment of children with Attention-Deficit/Hyperactivity Disorder (ADHD). This same mixture of amphetamine salts was previously marketed as Obetrol for treatment of obesity.

Methicillin-resistant Staphylococcus aureus (MRSA), which was traditionally a nosocomially-acquired organism but now frequently occurs in the absence of healthcare exposure, is the predominant cause of suppurative skin and soft-tissue infections in many parts of the US. Community-associated MRSA usually causes furunculosis, purulent cellulitis, and abscesses, but necrotizing fasciitis, necrotizing pneumonia, and sepsis can also occur.

The FDA has approved 2 oral drugs for treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone (Esbriet) has been available in Europe since 2011 and in Canada since 2012. Nintedanib (Ofev) is available only in the US.

Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten that occurs in about 1% of the population. The main form of treatment is a lifelong gluten-free diet.

Recent studies have caused concern about cardiomyopathy associated with doxorubicin (Adriamycin, and others), daunorubicin (Cerubidine, and others), idarubicin (Idamycin), mitoxantrone (Novantrone), and related anthracycline or anthraquinone anticancer drugs. Dexrazoxane (ADR-529, ICRF-187 - Adria), a piperazine derivative of ethylenediaminetetraacetic acid (EDTA), is now under investigation for prevention of this drug-induced cardiomyopathy.

The FDA has approved the oral GABA_A receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this indication; brexanolone (Zulresso), another GABA_A receptor modulator, was approved for IV treatment of PPD in 2019.

Sunitinib (Sutent - Pfizer) and sorafenib (Nexavar - Bayer), two oral tyrosine kinase inhibitors, have been approved by the FDA for treatment of advanced renal cell carcinoma (RCC). Sunitinib is also approved for use in patients with gastrointestinal stromal tumor (GIST) who are not responding to or are intolerant of standard therapy with imatinib (Gleevec).

The investigational oral antiviral drug molnupiravir (Merck/Ridgeback Biotherapeutics) was granted an FDA Emergency Use Authorization (EUA) on December 23, 2021 for treatment of mild to moderate COVID-19 in outpatients ≥18 years old who are at high risk of progressing to severe disease, including hospitalization or death (see Table 1), and for whom alternative treatment options are not available or clinically appropriate. Paxlovid (Pfizer), nirmatrelvir copackaged with ritonavir, was granted an EUA on December 22, 2021. The IV antiviral drug remdesivir (Veklury) was approved by the...

Four new drugs have become available in the USA for HIV infection or its complications. Nevirapine (Viramune - Roxane), intravenous cidofovir (Vistide - Gilead), and amphotericin B oral suspension (Fungizone Oral Suspension - Bristol-Myers Squibb) have been approved by the US Food and Drug Administration; nelfinavir (Viracept - Agouron) is currently available only through an "Expanded Access Program."