The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

The guanylate cyclase-C receptor agonist linaclotide (Linzess – Abbvie/Ironwood) was first approved by the FDA in 2012 for treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. The drug has now been approved for treatment of functional constipation in patients 6-17 years old. Linaclotide is the only drug to be approved in the US for treatment of functional constipation.

The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab was approved earlier for treatment of plaque psoriasis and psoriatic arthritis.

The FDA has approved osimertinib (Tagrisso – AstraZeneca), an oral kinase inhibitor, for adjuvant treatment of non-small cell lung cancer (NSCLC) after tumor resection in adults who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. Osimertinib is the first targeted therapy to be approved in the US for this indication. The drug was previously approved for first-line treatment of adults with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations and for treatment of EGFR T790M mutation-positive NSCLC in adults whose disease progressed...

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

The oral kinase inhibitor alpelisib (Vijoice – Novartis) has been approved by the FDA for treatment of patients ≥2 years old with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic treatment. Alpelisib is the first drug to be approved in the US for this indication. It was also approved in 2019 as Piqray for use in combination with fulvestrant for treatment of certain types of breast cancer.

Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response. KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation is the most common KRAS mutation. Sotorasib is the first KRAS inhibitor to be approved in the US.

The injectable interleukin (IL)-23 antagonist risankizumab-rzza (Skyrizi – Abbvie), previously approved by the FDA for treatment of Crohn's disease (CD), has now been approved for treatment of moderately to severely active ulcerative colitis (UC) in adults. Risankizumab is the first IL-23 antagonist to be approved for treatment of both CD and UC. It is also approved for treatment of plaque psoriasis and psoriatic arthritis.

Atopic dermatitis (AD; also known as eczema) is frequently associated with other atopic disorders such as allergic rhinitis, asthma, and food allergy. It commonly presents in infancy and early childhood and has a relapsing course, often improving by adolescence, but sometimes persisting into (or first appearing in) adulthood or even old age.

The FDA has approved Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Other oral colonoscopy preparations available in the US are listed in Table 2. Suflave is marketed as tasting better than other products.