💉 RFK Jr. has long advocated for changes to the US pediatric vaccine schedule. Now, as HHS secretary, he’s turned his anti-vaccine activism into reality. Federal health officials announced this week that they would align the country’s schedule with Denmark's, recommending routine vaccinations for 11 diseases instead of 17. 

The vaccines that will no longer be recommended as part of the routine schedule include shots for rotavirus, Covid-19, flu, hepatitis A, hepatitis B and meningococcal disease. The first three will instead be left up to an individual’s choice, while the hepatitis A and meningococcal shots will still be recommended for high-risk groups — and still involve individual choice. For the hepatitis B vaccine, where the first dose is usually given to infants within 24 hours after birth, the recommendation will be dependent on the mother’s infection status. 

✅ One of our annual traditions here at Endpoints is to recap the previous year’s FDA drug and biologic approvals, and we published our 2025 edition this week. The whole team was involved in this project, and a special shoutout goes to Nicole Wetsman, our deputy editor for events and special projects, for wrangling this together. 

There were 53 new drugs and biologics approved last year, a slight dip from 2024 and 2023. The fall came despite FDA Commissioner Marty Makary’s claim in July that 2025 would be a record year for new approvals. Non-small cell lung cancer saw the most approvals with five, though most of those products likely won’t compete with each other. The rare disease hereditary angioedema also saw a burst of approvals with three. 

👩‍💼 The rare disease drugmaker announced a leadership transition this week, which will see COO Karen Massey take over for current chief Tim Van Hauwermeiren on May 6. Massey becomes one of just a handful of women leaders at biopharma companies valued at over $50 billion, joining Vertex’s Reshma Kewalramani and Alnylam’s Yvonne Greenstreet. Only two other women lead biopharma companies with a market cap above $20 billion: Hansoh, founded by CEO Zhong Huijuan; and United Therapeutics, led by Martine Rothblatt. There are about 45 pharma companies with a market cap at or above $20 billion.

❌ In an unusual move, the FDA released a rejection letter within days of turning away a new drug application. In this instance, the agency published the letter for Sanofi’s tolebrutinib, which was submitted to treat multiple sclerosis. The rejection was due to “a serious risk of severe drug-induced liver injury.” Sanofi’s public statement on Dec. 24 announcing the rejection made no mention of the FDA’s comments around liver injury associated with the drug. 

Sanofi responded by noting the potential risks of drug-induced liver injury have been known since 2022, when a clinical hold on the drug was put in place. A company spokesperson noted the rejection was “unexpected” and that it “observed evolving perspectives within the FDA review team with new considerations introduced late in the review cycle.” 

📊 A very small number of patients appeared to lose weight when given Arrowhead’s RNAi-based product dubbed ARO-INHBE when combined with Eli Lilly’s GLP-1 Zepbound. After four months, patients with obesity and diabetes in a Phase 1/2a trial who took the combination lost 9.4% of their body weight. This was nearly twice as much as the control group, who took Zepbound plus placebo. They lost 4.8% of their weight.