The FDA has approved infliximab-dyyb (Inflectra – Pfizer; marketed as Remsima in some countries), as a biosimilar of the TNF inhibitor infliximab (Remicade). Infliximab-dyyb was approved in the European Union (EU) in 2013 and in Canada in 2014. It is the second biosimilar to be approved by the FDA. Filgastrim-sndz (Zarxio), a recombinant human granulocyte colony-stimulating factor, was the first.

The FDA has approved lofexidine (Lucemyra – US WorldMeds/Salix), a centrally acting alpha₂ receptor agonist, to manage withdrawal symptoms in adults abruptly stopping opioid use. Available in the UK since 1992, lofexidine is the first nonopioid to be approved in the US for management of opioid withdrawal symptoms. Clonidine (Catapres, and generics), another central alpha₂ receptor agonist, has been used off-label for this indication for many years.

Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is the second selective IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) was the first.

The FDA has approved the subcutaneously injected monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of patients ≥12 years old with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupilumab was approved earlier to treat adults with moderate to severe atopic dermatitis inadequately controlled with topical therapies.

Since 2008, because of safety concerns, the FDA has mandated that long-term cardiovascular outcomes trials be conducted for all new drugs for type 2 diabetes. Reductions in the incidence of macrovascular complications in these trials with some sodium-glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients at risk for cardiovascular disease (see Table 1) have led to new recommendations.

The FDA has approved the 5-HT4 receptor agonist prucalopride (Motegrity – Shire) for treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride is the only drug currently approved in the US for treatment of CIC that stimulates colonic peristalsis. It has been available in Europe and Canada for several years.

Most colorectal cancers arise from localized adenomatous polyps in a process that may take 10 years or more. Early detection and removal of a precancerous colonic lesion (polyp) can prevent cancer from developing.

The FDA has approved Apadaz (KemPharm), a short-acting, fixed-dose combination of benzhydrocodone and acetaminophen, for short-term management (≤14 days) of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate. Benzhydrocodone is a prodrug of hydrocodone. Fixed-dose combinations of short-acting hydrocodone and acetaminophen or ibuprofen have been available for years and are the most abused opioid products in the US. Apadaz was developed under the presumption that inclusion of the inactive prodrug would reduce the potential for...

The FDA has approved upadacitinib (Rinvoq – Abbvie), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or cannot tolerate methotrexate (Trexall, and others). Upadacitinib is the third JAK inhibitor to be approved in the US for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) and baricitinib (Olumiant) were approved earlier.

The FDA has approved a 4% aerosol foam formulation of minocycline (Amzeeq – Foamix) for topical treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old. It is the first topical tetracycline formulation to be approved for use in patients with acne. Oral minocycline (Minocin, Solodyn, and generics) is