The antibiotic aztreonam is now available as an inhalation solution (Cayston – Gilead) to improve respiratory symptoms in cystic fibrosis (CF) patients ≥7 years old colonized with Pseudomonas aeruginosa. It is the second inhaled antibiotic to be FDA-approved for this indication in CF patients; the aminoglycoside tobramycin (Tobi) was the first. Inhaled antibiotics offer the advantage of high airway concentrations while minimizing systemic side effects.

The average daily intake of sodium in the US is about 3400 mg. Dietary guidelines recommend reducing it to <2300 mg/day in general, and to 1500 mg for African Americans, persons with hypertension, diabetes or chronic renal disease, and for all those >50 years old. Salt reduction lowers blood pressure, and lowering blood pressure reduces the risk of myocardial infarction, stroke and death.

The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Glucarpidase has been available in the US since 2007 under a compassionate use open-label treatment protocol (Clinical Trials and Consulting Services, 1-877-398-9829), which will remain in effect until the drug becomes commercially available later this year. There is currently a shortage of IV methotrexate in the US.

Auvi-Q (Kaléo; previously manufactured and marketed by Sanofi), the epinephrine auto-injector approved by the FDA in 2012 for emergency treatment of anaphylaxis and voluntarily withdrawn in 2015 due to potential inaccurate dosage delivery, has become available once more. According to Kaléo, improvements in the manufacturing process have addressed the concerns that led to its recall.

View the Expanded Table: Antibiotics for Travelers' Diarrhea

The short-acting formulation of mixed amphetamine salts (Adderall, and generics) FDA-approved for treatment of attention-deficit hyperactivity disorder (ADHD) and narcolepsy, is currently in short supply in the US. Until an adequate supply is restored, patients may be looking for alternatives.

Efbemalenograstim alfa-vuxw (Ryzneuta – Evive), a nonpegylated granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG2, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia. It is the first nonpegylated, long-acting G-CSF to become available in the US. Two pegylated, long-acting G-CSFs, pegfilgrastim (Neulasta, and biosimilars) and eflapegrastim (Rolvedon), are...

Zenocutuzumab (Bizengri – Merus), a bispecific HER2- and HER3-directed antibody, has received accelerated approval from the FDA for treatment of advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion in adults who had disease progression on or after prior systemic therapy. It is the first drug to be approved in the US for treatment of NRG1-positive cancers. Accelerated approval of zenocutuzumab was based on the overall response rate and duration of response.

Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval from the FDA for treatment of unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer in patients who received prior therapy. Biliary tract cancer includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma. Zanidatamab is the first dual HER2-targeted therapy to be approved in the US for this indication. Accelerated approval was based on the overall response rate and duration of response.

The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults.Abrysvo is also approved for use in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.