About 50% of the world’s population is infected with Helicobacter pylori. These gastric bacteria can cause chronic inflammation and have been associated with development of gastritis, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Eradication of H. pylori can promote gastric healing, prevent recurrence of duodenal and gastric ulcers, and reduce the incidence of gastric cancer. Guidelines for treatment of H. pylori infection were updated recently.

Taletrectinib (Ibtrozi – Nuvation Bio), an oral kinase inhibitor, has been approved by the FDA for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. It is the fourth oral kinase inhibitor to be approved in the US for this indication; crizotinib (Xalkori), entrectinib (Rozlytrek), and repotrectinib (Augtyro) were approved earlier.

The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

The FDA has approved a 6% otic suspension formulation of the fluoroquinolone antibiotic ciprofloxacin (Otiprio – Otonomy) for single-dose treatment of acute otitis externa (swimmer's ear) caused by Pseudomonas aeruginosa or Staphylococcus aureus in patients ≥6 months old. Otiprio was approved earlier for prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Pemigatinib is the first drug to be approved in the US for this indication.

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The FDA has approved ciprofloxacin 6% otic suspension (Otiprio – Otonomy) for single-dose prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement. It is the first drug to be approved for this indication in the US. Otic formulations of the fluoroquinolone antibiotics ofloxacin (Floxin Otic, and generics) and ciprofloxacin (plus dexamethasone; Ciprodex) have been available for years for treatment of acute otitis media in children with tympanostomy tubes; an otic suspension containing ciprofloxacin and fluocinolone...

Palbociclib (Ibrance – Pfizer), an oral cyclin-dependent kinase inhibitor, has been approved by the FDA for use in combination with the aromatase inhibitor letrozole (Femara, and generics) for first-line treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. It is the first cyclin-dependent kinase inhibitor to become available in the US.

Three extended-release injectable formulations of second-generation antipsychotic drugs — two of risperidone (Rykindo, Uzedy) and one of aripiprazole (Abilify Asimtufii) — have been approved by the FDA for treatment of schizophrenia in adults. Rykindo and Abilify Asimtufii are also approved for maintenance treatment of bipolar I disorder in adults. Other extended-release injectable formulations of risperidone and aripiprazole have been available in the US for years (see Table 1).

The oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) has been approved by the FDA for treatment of giant cell arteritis. Upadacitinib was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease.