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• From an outright refusal to file to a backpedaled review earlier this year, Moderna has secured the FDA’s approval for its mRNA-based flu vaccine mFluvisa.

• The decision, revealed late yesterday, grants traditional approval for mFluvisa to prevent seasonal influenza in patients 50 through 64 years of age, and accelerated approval for use in people 65 years and older.

• MFluvisa is the first mRNA-based flu shot in the US, according to Moderna’s announcement.

• The company expects to make mFluvisa available “in the coming weeks,” in time for the 2026-2027 respiratory virus season in the US. Moderna didn’t disclose pricing for mFluvisa. (BioSpace)

• The FDA approved Orzeyful (oveporexton), an oral orexin receptor agonist, for a form of narcolepsy – opening up the market for a drug class that key opinion leaders (KOLs) are touting as a new frontier in the indication.

• The twice-daily therapy will soon become available to American patients with narcolepsy type 1, which is a lifelong sleep disorder characterized by daytime sleepiness, sudden muscle weakness and other debilitating symptoms like nighttime sleep disruptions, hallucinations and sleep paralysis.

• The FDA approved Orzeyful based on the results of the phase 3 FirstLight and RadiantLight trials, in which the therapy significantly improved patients’ ability to remain awake during the day over those in the placebo arm.

• The drug also offered meaningful improvements across a wide spectrum of narcolepsy symptoms, including disrupted nighttime sleep, hallucinations and sleep paralysis. (Pharmaceutical Technology)

• Last Friday, the FDA approved Novartis’ radiopharma drug Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use alongside hormone therapy, making the drug available to many more patients.

• The approval nearly doubles the eligible patient population for Pluvicto, according to a press release. It’s an important nod for Novartis, which has bet big on the radiopharmaceutical industry.

• Pluvicto leads the up-and-coming class of drugs and reported $2 billion in sales last year. Novartis has said that it expects Pluvicto to reach $5 billion or more in sales at its peak. (Endpoints)

• On one hand, biotech and regulatory leaders are on board with a pilot program to speed early trials in hopes of bringing them back to the US.

• But former regulators point to roadblocks to running first-in-human trials that are beyond the FDA’s control.

“FDA is not the primary source of most delays in early phase clinical trials,” Harpreet Singh, a former division director of oncology at FDA, said. The major delays instead occur at the site level, she said.

• By simplifying the investigational new drug (IND) application and approval process, the health department—including the FDA—aim to make the US more competitive as an ideal location to run these trials.

• China’s National Medical Products Administration has also overtaken the FDA in terms of cancer approvals, greenlighting 94 oncology drugs between 2020 and 2025 compared to the 87 that entered the US market in the same timeframe, per a new Health Affairs Scholar study.

• Six weeks after Eli Lilly granted a single 79-year-old patient special access to retatrutide, an unapproved obesity drug, the company confirmed on Monday that it will allow other patients to apply for early access.

• It marks a striking change in the public posture of the pharmaceutical giant, which had previously offered little information about the special access program.

• “For a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial, we believe it is medically appropriate to make authentic retatrutide available before FDA approval, consistent with FDA’s guidance,” a Lilly spokesperson said.

• The company said it is actively reviewing requests from health care providers. (STAT)

• In a milestone for IgA nephropathy, Voyxact has shown for the first time in a phase 3 trial that a drug can stabilize patients’ kidney function decline to the normal rate seen in healthy adults.

• Results from the Visionary trial showed that Voyxact (sibeprenlimab) achieved an annualized estimated glomerular filtration rate (eGFR) slope of a 0.3 mL/min/1.73m² gain over two years, suggesting an improvement in kidney function.

• The rate matches the normal age-related decline of less than 1 mL/min/1.73m² per year, as laid out in the KDIGO 2025 Clinical Practice Guideline for IgAN.

• To be presented at the GlomCon Hawaii 2026 conference, the latest Voyxact result is better than an annualized eGFR slope of negative 4.2 mL/min/1.73m² for placebo.

• It’s also better than Voyxact’s own performance over 12 months, when it recorded an annualized loss of 3 mL/min/1.73m² at an interim analysis of the Visionary trial. (Fierce Pharma)

• Curium will merge with Lantheus, in an arrangement where Lantheus falls under the umbrella of Curium’s US wholly-owned subsidiary.

• Together, the two parties will create a unified radiopharmaceutical company covering diagnostics and therapeutics, particularly in oncology, where Curium specializes.

• Curium and Lantheus say they mutually have the infrastructure and capabilities to serve patients in more than 70 countries.

• The merger plans to span the full nuclear medicine value chain. This runs from isotope production and manufacturing to diagnostic imaging and targeted radionuclide therapy. (Contract Pharma)

• Kalshi also plans to allow users to bet on whether drug trials will succeed.

• They said they worry that study results could be compromised, insider trading could go undetected and public trust could be eroded.

“Turning loose a betting market in an ongoing randomized clinical trial really is a breach of scientific conduct,” Dr. Robert Califf, who was the FDA commissioner in the Biden administration, said.

• The platforms have also generated mounting scrutiny over how they police trading based on inside information.

• As of publication time, traders collectively gave it a 64 percent probability for approval by the end of this year.