A new systematic review and meta-analysis of studies looking at a possible association between Tylenol (acetaminophen) use in pregnancy and neurodevelopmental disorders in children concludes there is no evidence of any meaningful risk. The study was carried out by researchers in the U.K., Italy, Sweden and Norway, in response to U.S. Secretary of Health and Human Services Robert Kennedy saying last September that there is a link. Unless medically necessary, it is “irresponsible” to take Tylenol during pregnancy, Kennedy said.

For decades, scientists have searched for a mechanistic link between viral infection and multiple sclerosis (MS). Insights from three studies recently published in Cell bring that connection into sharper focus. By tracing how the immune system responds to Epstein-Barr virus (EBV) – and how those responses can misfire against the brain – researchers are beginning to uncover a compelling biological explanation for MS.

Years after approving three glucagon-like peptide-1 (GLP-1) receptor agonists to treat obesity, the U.S. FDA is acknowledging that the drugs don’t have the same risk seen with older weight-loss medicines. Citing its post-market evaluation that found no increased risk of suicidal ideation or behavior, the U.S. FDA is requesting that the risk be removed from the warnings and precautions section of labeling for the GLP-1 obesity drugs – Eli Lilly and Co.’s Zepbound (tirzepatide) and Novo Nordisk A/S’ Saxenda (liraglutide) and Wegovy (semaglutide).

Perhaps the biggest indicator of U.S. President Donald Trump’s activism in his second term is the 225 executive orders (EOs) he issued in 2025. The pace of those orders seems to have slowed, with “only” 16 released in the last quarter of the year. Four of the recent EOs could impact drug and device companies in a myriad of ways.

The U.S. FDA has approved Zycubo (copper histidinate) as the first treatment for Menkes disease, a rare, genetic disease affecting children who cannot absorb copper through their intestines, leading to seizures, weak muscles, a failure to thrive and, ultimately, if left untreated, an early death by age 3.

Stoke Therapeutics Inc.’s speeded-up timeline for zorevunersen, the antisense oligonucleotide in development with Biogen Inc. as a first-in-class potential disease-modifying treatment for Dravet syndrome, put the rare, severe form of lifelong epilepsy in the spotlight. The news involved completion of enrollment and a phase III data readout from the Emperor study, as officials said signups of 150 patients are expected in the second quarter of the year, which puts the study on track for data in mid-2027.

On the last day of the year, shares of Axsome Therapeutics Inc. rose 22% on news that the U.S. FDA accepted and granted priority review of the company’s supplemental NDA for AXS-05 to treat Alzheimer’s disease agitation, a $1 billion-plus opportunity, scheduling the PDUFA date for April 30.