FDA Approved Pluvicto Plus ARPI for PSMA-Positive mAPMN/S Prostate Cancer
oncodaily - On July 31, 2026, the US Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan, marketed as Pluvicto, in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults […]
AI Summary: The FDA has approved an expanded use for a lutetium‑177 radiopharmaceutical (Pluvicto), broadening access for PSMA‑positive metastatic prostate cancer patients and potentially speeding the adoption of targeted radionuclide therapy. Clinicians note the approval could shift treatment sequencing and patient pathways, with implementation details and eligibility criteria guiding real‑world impact.
- Access, dose optimization and real-world data for Lu-177 (4)
- FDA expands Pluvicto approval; industry reaction (3)
- PSMAddition trial: earlier Lu-177 delays metastatic progression (5)
Access, dose optimization and real-world data for Lu-177
FDA expands Pluvicto approval; industry reaction
PSMAddition trial: earlier Lu-177 delays metastatic progression
FDA approves first drug for full range of narcolepsy symptoms
medicalxpress - The U.S. Food and Drug Administration has approved Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults. Orzeyful marks the first medication approved for the full range of symptoms associated with narcolepsy type 1 and is the first approved…
AI Summary: The FDA has approved a medication that treats the full range of narcolepsy symptoms, including excessive daytime sleepiness and cataplexy, marking the first such comprehensive option for patients with narcolepsy type 1. Clinicians now have a single, regulated choice to address multiple debilitating symptoms rather than juggling piecemeal therapies.