The FDA has approved Lasix ONYU (SQ Innovation), a subcutaneous formulation of the loop diuretic furosemide administered via a wearable pump (onbody infusor), for treatment of edema in adults with chronic heart failure (HF). A similar product, Furoscix, is approved for treatment of edema in chronic HF or chronic kidney disease. Furosemide has been available for years in oral and IV formulations for such use.

The FDA has licensed the adjuvanted, recombinant varicella zoster virus (VZV) vaccine Shingrix (GSK) for prevention of herpes zoster (shingles) in adults of any age who are or will be at elevated risk because of disease- or therapy-induced immunodeficiency or immunosuppression. Shingrix has been licensed for herpes zoster prevention in adults ≥50 years old since 2017.1 It is the only VZV vaccine currently available in the US; Zostavax, a live-attenuated VZV vaccine, was withdrawn from the market in 2020.

Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA for treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults. Accelerated approval of the drug was based on the response rate and duration of response. Retifanlimab is the third drug to be approved in the US for treatment of MCC; pembrolizumab (Keytruda), a PD-1 blocking antibody, is approved for the same indication as retifanlimab in patients ≥12 years old and avelumab (Bavencio), a programmed death...

View the Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Constipation (IBS-C)

Atogepant (Qulipta – Abbvie), an oral small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), has been approved by the FDA for prevention of episodic migraine in adults. It is the second oral CGRP receptor antagonist to be approved in the US for this indication; the first was rimegepant (Nurtec ODT), which is also approved for acute treatment of migraine. Parenteral CGRP monoclonal antibodies are approved for prevention of migraine (see Table 3).

The recombinant respiratory syncytial virus (RSV) vaccine Arexvy (GSK) has now received FDA approval for use in adults 50-59 years old who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV. It was previously approved only for adults ≥60 years old. Two other RSV vaccines have received FDA approval: Abrysvo, a recombinant vaccine that is licensed for use in adults ≥60 years old and in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants, and mResvia, an mRNA vaccine recently licensed for use in adults ≥60 years old...

The FDA has approved the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) vadadustat (Vafseo – Akebia) for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 3 months. Vadadustat is the second HIF-PHI to be approved in the US for this indication; daprodustat (Jesduvroq) was approved earlier, but it was withdrawn from the US market in 2024 for commercial reasons.

The injectable interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) is now FDA-approved for treatment of moderately to severely active Crohn's disease (CD) in adults. Mirikizumab was approved in 2023 for treatment of ulcerative colitis. Two other IL-23 antagonists, risankizumab (Skyrizi) and guselkumab (Tremfya), are also approved for treatment of CD.

The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.

The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases. The drug received accelerated approval for the same indication in 2020 based on initial overall response rates and duration of response.