The Medical Letter - 2025
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January 20, 2025 (Issue 1720)
- Valeda Light Delivery System for Age-Related Macular Degeneration The FDA has authorized use of the Valeda Light Delivery System (LumiThera), a multiwavelength photobiomodulation (PBM) device, to improve visual acuity in patients with dry age-related macular degeneration...
- Emrosi — Low-Dose, Biphasic Oral Minocycline for Rosacea Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea...
- Dupilumab (Dupixent) for COPD The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately...
- Seladelpar (Livdelzi) for Primary Biliary Cholangitis Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid...
- Zenocutuzumab (Bizengri) for NSCLC and Pancreatic Adenocarcinoma Zenocutuzumab (Bizengri – Merus), a bispecific HER2- and HER3-directed antibody, has received accelerated approval from the FDA for treatment of advanced, unresectable or metastatic non-small cell lung...
- Zanidatamab (Ziihera) for Biliary Tract Cancer (online only) Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval from the FDA for treatment of unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer...
January 6, 2025 (Issue 1719)
- Drugs for Age-Related Macular Degeneration Age-related macular degeneration (AMD) has two major forms: dry or non-neovascular (~90% of patients) and wet or neovascular (~10% of patients).
- Qlosi — Pilocarpine 0.4% Ophthalmic Solution for Presbyopia The FDA has approved pilocarpine 0.4% preservativefree ophthalmic solution (Qlosi – Orasis) for treatment of presbyopia in adults. Pilocarpine 1.25% ophthalmic solution (Vuity) was approved in 2021 for the...
- Vyalev — Foscarbidopa/Foslevodopa Subcutaneous Infusion for Parkinson's Disease Vyalev (Abbvie), a solution for continuous subcutaneous infusion containing the prodrugs foscarbidopa and foslevodopa, has been approved by the FDA for treatment of motor fluctuations in adults...
- Revumenib (Revuforj) for Acute Leukemia (online only) Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A...