The FDA has approved Inlexzo, a gemcitabine intravesical system, for treatment of Bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. The Inlexzo system is placed into the bladder to deliver gemcitabine for 3 weeks.

Nerandomilast (Jascayd – Boehringer Ingelheim), an oral phosphodiesterase 4 (PDE4) inhibitor, has been approved by the FDA for treatment of idiopathic pulmonary fibrosis (IPF) in adults. It is the third drug to be approved in the US for this indication; the oral antifibrotic drugs pirfenidone (Esbriet, and generics) and nintedanib (Ofev) were approved in 2014.

View the Comparison Table: Some Oral/Transdermal Opioid Analgesics

Initial treatment of allergic rhinitis (AR) depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).

View the Comparison Table: Triptans for Migraine

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

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.

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has been approved by the FDA for adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who received prior neoadjuvant or adjuvant chemotherapy. The drug was previously approved for treatment of adults with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who received chemotherapy in the neoadjuvant, adjuvant, or metastatic...

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has now been approved by the FDA for use in combination with abiraterone (Zytiga, and others) and either prednisone or prednisolone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib was previously approved by the FDA for treatment of adults with deleterious or suspected deleterious germline or somatic homologous recombinant repair (HRR) genemutated mCRPC who progressed on prior treatment with...

The recombinant interleukin-1 (IL-1) receptor antagonist anakinra (Kineret – Sobi) has been granted an FDA Emergency Use Authorization (EUA) for treatment of hospitalized adults with confirmed COVID-19 pneumonia who require low- or high-flow supplemental oxygen, are at risk of progressing to severe respiratory failure, and are likely to have elevated plasma levels of soluble urokinase plasminogen activator receptor (suPAR). Anakinra has been available in the US for years; it is FDA-approved for multiple indications, including rheumatoid arthritis. Assays for suPAR are...