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US FDA Approves Use of Sanofi’s Meningococcal Vaccine in Infants
French drugmaker Sanofi said the U.S. Food and Drug Administration has approved its meningococcal vaccine for use in infants as young as six weeks, making it the first shot intended for the age group. The vaccine, branded as MenQuadfi, is already approved for individuals aged two years and older to protect against the four most common strains of meningococcal bacteria — A, C, W and Y, the company said on Friday.
Meningococcal infections, caused by the Neisseria meningitidis bacteria, can cause serious, sometimes deadly, bloodstream infections, as well as severe swelling in the brain and spinal cord. British drugmaker GSK’s shot Menveo is approved in children as young as two months and adults up to 55 years of age.
“I think for convenience factor and accessibility… it is nice to have options,” said Dr. Patty Sabey, a pediatrician with Stanford Medicine Children’s Health, ahead of the decision. The approval was based on data from three late-stage studies involving more than 6,000 participants aged six weeks to 19 months, which showed that MenQuadfi was as effective as Menveo when co-administered with other routine pediatric vaccines.
Popular Allergy Medications Linked to Severe Withdrawal Symptoms, FDA Warns
Two common allergy medications could cause a severe reaction in some people who stop using it. The U.S. Food and Drug Administration (FDA) issued an alert related to cetirizine (Zyrtec) or levocetirizine (Xyzal), warning that patients who stop taking it after long-term use may experience “rare but severe itching,” a condition called pruritus.
The itching was reported by people who used the medicines every day for months or years, and then stopped using them. In total, 209 cases were reported worldwide (197 in the U.S.) between April 25, 2017, and July 6, 2023. “This number includes only reports submitted to FDA, so there may be additional cases of which we are unaware,” the agency stated in the release.
“Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention.” Many reports described a “significant and persistent impact on quality of life and ability to function,” the FDA noted.
Why the FDA Recalled Six Popular Acne Products
Yale School of Medicine reported:
In March, the U.S. Food and Drug Administration (FDA) announced voluntary recalls of several popular acne products due to contamination with benzene, a known cancer-causing chemical. The FDA was prompted to conduct its own testing after receiving a report from Valisure, an independent drug quality control testing laboratory based in New Haven, Conn., highlighting concerns about the safety of certain topical products containing the active ingredient benzoyl peroxide (BPO).
BPO is a chemical commonly used in acne products for killing the bacteria that is associated with breakouts and inflammation. However, over time, it can break down into the carcinogen benzene, researchers have found. The Valisure team tested the stability of a variety of acne products containing BPO. They discovered that many violated the conditional FDA limit of two parts per million (ppm), with some containing levels as high as 35 ppm.
They published their initial findings in Environmental Health Perspectives in March 2024, and a follow-up study in the Journal of Investigative Dermatology in October 2024. “Benzene is in your acne products, it’s in your dry shampoos, it’s in your sunscreens, it’s in second-hand or direct cigarette smoke, it’s in exhaust from cars. It’s all the benzene exposure throughout all of society that adds cumulative risk. And the last place consumers need additional risk is in an acne product.” — Christopher Bunick, M.D., Ph.D.
Rocket Crashes as Gene Therapy Patient Dies, FDA Imposes Hold
The U.S. Food and Drug Administration (FDA) has slapped a clinical hold on Rocket Pharmaceuticals’ pivotal gene therapy trial in response to a death. Rocket, which was aiming to report data in mid-2026, dropped its targeted trial completion date and outlined actions to extend its cash runway after suffering the setback.
New Jersey-based Rocket is testing its gene therapy RP-A501 in patients with Danon disease, a condition associated with weakening of the heart muscle. The biotech’s pivotal phase 2 trial is assessing the AAV9 gene therapy in 12 patients to support accelerated approval. RP-A501 is designed to fully restore cardiac function by delivering the LAMP2B transgene to heart cells.
Rocket stopped dosing in the phase 2 study and notified the FDA after a patient developed complications linked to capillary leak syndrome. Gaurav Shah, M.D., CEO at Rocket, discussed the timeline of events on a call with investors Tuesday, explaining that the company saw signs of capillary leak around one week after infusion.
