Fotivda-Tivozanib
Later-line renal cell carcinoma has accumulated several VEGF-targeted options, and tolerability increasingly separates them. Fotivda (tivozanib) was positioned for heavily pretreated patients. Tivozanib is an oral VEGF receptor tyrosine kinase inhibitor whose selectivity for VEGFR1-3 aims to limit off-target effects. Dosed once daily on a three-weeks-on, one-week-off cycle, it treats adults with relapsed or refractory […]
Azstarys-Serdexmethylphenidate And dexmethylphenidate
Stimulant therapy for ADHD depends heavily on how quickly a dose takes effect and how long it lasts. Azstarys (serdexmethylphenidate and dexmethylphenidate) approached that problem through prodrug chemistry. The capsule combines immediate-release dexmethylphenidate with serdexmethylphenidate, a prodrug converted to active drug in the lower gastrointestinal tract, delivering early onset from one component and extended coverage […]
Pepaxto-Melphalan Flufenamide
Pepaxto (melphalan flufenamide) tested whether a peptide-drug conjugate could deliver alkylating chemotherapy more selectively into myeloma cells. It became a landmark case in accelerated approval enforcement instead. Relying on aminopeptidase-driven cleavage inside tumor cells, it concentrated its alkylating payload where it was needed. Accelerated approval covered its use with dexamethasone for relapsed or refractory multiple […]
Nulibry-Fosdenopterin
Nulibry (fosdenopterin) was the first therapy approved for molybdenum cofactor deficiency Type A, an ultra-rare metabolic disorder that is usually fatal in infancy and had nothing to change its course. It supplies cPMP, the substrate these patients cannot synthesize, allowing the body to make molybdenum cofactor and clear the neurotoxic sulfite that otherwise accumulates. The […]
Amondys 45-Casimersen
Duchenne muscular dystrophy is caused by mutations that halt dystrophin production, and exon-skipping therapies are tailored to specific mutation subsets. Amondys 45 (casimersen) serves patients amenable to exon 45 skipping. Casimersen is a phosphorodiamidate morpholino antisense oligonucleotide that masks exon 45 during RNA processing, letting cells produce a shortened but partially functional dystrophin protein. Infused […]
Cosela-Trilacicilib
Chemotherapy-induced myelosuppression has traditionally been managed after the fact with growth factors and transfusions. Cosela (trilaciclib) introduced the idea of protecting the bone marrow before chemotherapy is even given. Administered intravenously shortly before chemotherapy, Cosela transiently pauses the cell cycle of blood-forming stem cells so cytotoxic drugs spare them. It is approved to reduce chemotherapy-induced […]
Ukoniq-Umbralisib
Ukoniq (umbralisib) entered a crowded PI3K inhibitor class with a differentiated dual-target design, and its trajectory became one of the clearest cautionary tales in the field. It was an oral inhibitor of both PI3K-delta and casein kinase-1 epsilon, a dual-target design intended to improve tolerability over earlier PI3K agents. Accelerated approval covered relapsed or refractory […]
Tepmetko-Tepotinib
Tepmetko (tepotinib) targets MET exon 14 skipping alterations, which drive a small but distinct subset of lung cancer that had few targeted options until recently. Taken once daily, tepotinib selectively blocks MET kinase signaling to slow tumor growth in adults with metastatic non-small cell lung cancer harboring MET exon 14 skipping alterations. It was the […]
Lupkynis-Voclosporin
Lupus nephritis has historically been treated with broad immunosuppression and steroids, with remission rates that left substantial room for improvement. Lupkynis (voclosporin) arrived as the first FDA-approved oral therapy developed specifically for the condition. It is a calcineurin inhibitor that reduces the immune-driven kidney inflammation behind proteinuria, while also stabilizing the podocytes that maintain the […]
Cabenuva-Cabotegravir And Rilpivirine (Co-Packaged)
Cabenuva broke a pattern that had defined HIV treatment for decades, in which staying suppressed meant taking pills every single day. It is the first complete long-acting injectable regimen approved for HIV-1. The regimen co-packages cabotegravir, an integrase strand transfer inhibitor, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor, given as intramuscular injections once monthly or […]
