Morning Briefing
Summaries of health policy coverage from major news organizations
Third Time's A Charm: FDA Approves Melanoma Drug After Roller Coaster Of Rejections
MedPage Today: FDA Finally OKs Twice-Rejected Melanoma Drug
The FDA granted accelerated approval to vusolimogene oderparepvec (Tudriqev), known as RP1, in combination with nivolumab (Opdivo) to treat adults with unresectable advanced cutaneous melanoma, the agency announced Thursday. The genetically modified oncolytic viral therapy is indicated for patients who experienced disease progression with an anti-PD-1-based therapy. (Bassett, 8/6)
MedPage Today: FDA Approves First-In-Class Narcolepsy Drug
The FDA approved oveporexton (Orzeyful) for the treatment of narcolepsy type 1 (narcolepsy with cataplexy) in adults, the agency announced Wednesday. Oveporexton is a first-in-class orexin treatment that goes beyond symptom relief alone and targets the root cause of the rare sleep disorder. (Lou, 8/6)
The New York Times: A Promising Heart Drug Fails, Challenging A Long-Held Theory Of Disease
Novo Nordisk stunned the cardiology world last week when it announced that a large study it was running on an experimental drug for heart disease had failed. The drug, widely expected to be a blockbuster, was no better than a placebo. The drug, ziltivekimab, reduces inflammation, which is generally thought to be a cause of atherosclerosis. Stopping that inflammation was hoped to be a way to save lives. (Kolata, 8/6)
Also —
Modern Healthcare: What To Know About Medtronic’s Hernia Mesh Jury Verdict
A federal court jury decided Medtronic must pay an Alabama man and his wife $88 million after finding the company failed to adequately warn of the risks associated with one of its hernia mesh products. The Tuesday verdict was the first to come out of thousands of lawsuits filed against the company over its hernia mesh products. Medtronic and certain of its subsidiaries have been named as defendants in lawsuits filed in state and federal courts on behalf of about 10,350 consumers as of June 10, according to the company’s 2026 annual report. (Dubinsky, 8/6)
Stat: Study On Tau Protein May Bring Alzheimer's Drug Closer To Reality
In the race for new ways to treat Alzheimer’s and other devastating neurologic diseases, the protein tau has become a tantalizing target for drug developers. A new study lends support to those efforts by describing a previously unknown role that tau plays in neurodegeneration — and suggesting a novel way researchers might block the protein’s activity. (Wosen, 8/6)
