Eflapegrastim-xnst ((Rolvedon) [Spectrum]; previously called Rolontis), a granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG4, 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.

Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, in patients with RAS wild-type mutations, anti-EGFR therapy. The drug can be used in patients with mCRC regardless of biomarker status. Fruquintinib is the first drug to become available in the US for treatment of mCRC that targets 3 VEGF receptor kinases.

The FDA has approved the dual endothelin receptor antagonist aprocitentan (Tryvio – Idorsia) for use in combination with other antihypertensive drugs to treat hypertension in adults whose blood pressure is not adequately controlled on other drugs. Three other dual endothelin receptor antagonists, ambrisentan (Volibris, and generics), bosentan (Tracleer, and generics), and macitentan (Opsumit), are available in the US for treatment of pulmonary arterial hypertension.

The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of extensive-stage small cell lung cancer (SCLC) in adults who had disease progression on or after platinum-based chemotherapy. It is the first bispecific DLL3-directed CD3 T-cell engager to be approved in the US for this indication. Most patients with SCLC have a response to initial treatment, but progression generally occurs within a few months and overall survival is usually less than 8 months....

The FDA has approved Aurlumyn (Eicos Sciences), an IV formulation of the prostacyclin analog iloprost, to reduce the risk of digit amputation in adults with severe frostbite. Iloprost is the first drug to be approved by the FDA for treatment of severe frostbite; it has been used off-label for this indication in the EU and elsewhere for decades. In the US, iloprost is also available as an inhaled formulation (Ventavis) for treatment of pulmonary arterial hypertension.

Marstacimab-hncq (Hympavzi – Pfizer), a tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. It is the first hemophilia treatment to be approved in the US that targets an inhibitor of coagulation and the first to become available in prefilled pens and syringes for subcutaneous administration.

The FDA has approved vutrisiran (Amvuttra – Alnylam), a subcutaneously injected small interfering RNA (siRNA), to reduce cardiovascular hospitalizations, urgent heart failure visits, and cardiovascular death in adults with wild-type or variant transthyretin amyloid cardiomyopathy (ATTR-CM). Vutrisiran is the first siRNA to be approved in the US for this indication; it was approved earlier for treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

Fluoxetine (Prozac - Dista), a phenylpropylamide, is the first serotonin-reuptake blocker introduced in the USA for treatment of . It is being promoted as causing fewer adverse effects than other antidepressants. Claims of greater safety and patient tolerability have often been made for new non-tricyclic antidepressants in recent years, but unpredicted adverse effects have emerged with widespread use, including priapism with trazodone (Desyrel - Medical Letter, 26:35, 1984) and fatal hemolytic anemia with nomifensine (Merital - Medical Letter, 27:73, 1985).