Vusolimogene oderparepvec (Tudriqev – Replimune), a genetically-modified herpes simplex virus type 1 (HSV-1) oncolytic therapy, has been granted accelerated approval by the FDA for use in combination with the programmed death receptor-1 (PD-1)-blocking antibody nivolumab (Opdivo) for treatment of unresectable advanced cutaneous melanoma in adults who had disease progression on a PD-1-blocking antibody-based regimen. About 30-50% of patients develop primary resistance to anti-PD-1 therapy. The oncolytic viral therapy talimogene laherparepvec (Imlygic) was approved in 2015 for...

The rapid-acting inhaled human insulin Afrezza (MannKind), which was approved in 2014 for treatment of type 1 or type 2 diabetes in adults, has now been approved by the FDA for use in children ≥6 years old.

Iberdomide (Zenbexus – BMS), an oral first-in-class cereblon-modulating protein degrader, has received accelerated approval from the FDA for use in combination with the CD38-directed cytolytic antibody daratumumab (Darzalex Faspro) and dexamethasone for treatment of multiple myeloma in adults who received at least one prior line of therapy, including a proteasome inhibitor (e.g., bortezomib) and an immunomodulatory drug. The drug was approved based on a surrogate endpoint of minimal residual disease-negative complete response.

Zidesamtinib (Jideytro – GSK), 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 who received at least one prior ROS1 kinase inhibitor. It is the fifth oral kinase inhibitor to be approved in the US for treatment of ROS1-positive NSCLC; crizotinib (Xalkori), entrectinib (Rozlytrek), repotrectinib (Augtyro), and taletrectinib (Ibtrozi) were approved earlier.

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The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

The FDA has approved the sodium-glucose co-transporter 2 (SGLT2) inhibitor ertugliflozin (Merck) for treatment of adults with type 2 diabetes, both alone (Steglatro) and in fixed-dose combinations with metformin (Segluromet) and sitagliptin (Steglujan). Ertugliflozin is the fourth SGLT2 inhibitor to be approved in the US. All four are available in combination with metformin and three are available in combination with a dipeptidyl peptidase-4 (DPP-4) inhibitor (see Table 3).

The FDA has approved Plenvu (Salix), a polyethylene glycol (PEG)-containing oral powder for reconstitution, for colon cleansing prior to colonoscopy in adults. Plenvu is the first PEG-containing colonoscopy preparation that requires only 1 L of water for dissolution and ingestion of 1 L of clear fluid in addition.

The FDA has approved omadacycline (Nuzyra – Paratek), a semisynthetic tetracycline derivative, for once-daily IV and oral treatment of community-acquired bacterial pneumonia (CAP) and acute bacterial skin and skin structure infections (ABSSSIs) in adults.

The FDA has approved romosozumab-aqqg (Evenity – Amgen), a sclerostin inhibitor, for once-monthly subcutaneous (SC) treatment of osteoporosis in postmenopausal women who are at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or cannot tolerate other drugs for this indication. Romosozumab is the first sclerostin inhibitor to be approved in the US and the third drug for treatment of postmenopausal osteoporosis that stimulates bone formation; the parathyroid hormone (PTH) receptor agonists abaloparatide (Tymlos) and...