Fda

• FDA ties multistate E. coli outbreak sickening multiple individuals to cheese made with unpasteurized raw milk. • Highlights risks of raw dairy products in public health alerts. • Investigation ongoing to prevent further cases amid rising food safety concerns.

• Elijah Dottery, diagnosed with sickle cell anemia as a baby, became the first U-M patient to receive the newly FDA-approved stem cell therapy. • The treatment uses patient's own stem cells edited via CRISPR to produce functional hemoglobin, administered at Michigan Medicine. • This breakthrough matters for over 100,000 U.S. sickle cell patients, offering potential cure where prior therapies only managed symptoms.

Researchers say ‘magic mushrooms’ can help with traumatic symptoms, but urge caution as states expand accessSign up for the Breaking News US email to get newsletter alerts in your inboxAfter three combat deployments in Afghanistan, during which he suffered traumatic brain injuries from concussive blasts, army ranger Jesse Gould developed post-traumatic stress disorder and said he “drank almost every night to cope”.In times of hardship, veterans sometimes turn to “medication and talk therapy, but it tends to be more of a maintenance program than actually overcoming it”, Gould said, but added that at age 38, “I was still very young. I didn’t want to be on medication the rest of my life.” Continue reading...

• FDA has approved an investigational new drug application for synthetic CAR-T (sCAR-T) therapy targeting autoimmune conditions. • The clearance enables clinical trials to test this engineered cell therapy in US patients with refractory autoimmune diseases. • sCAR-T represents a novel approach adapting cancer immunotherapy for immune disorders, potentially offering durable remissions.

• FDA approved Haleon's Narcan 4mg nasal spray for non-prescription sale on April 7, 2026, building on 2023 authorization. • Reversal success rate 98% in trials with 150 US overdose simulations; priced at $29.95 for two-pack. • Addresses 110,000 annual US opioid deaths; 'Lifeline for bystanders,' says FDA Commissioner.

• The FDA granted approval on April 7, 2026, to Moderna's mRESVIA vaccine, an mRNA-based shot targeting respiratory syncytial virus (RSV) for adults aged 60 and older. • Clinical trials showed 83.7% efficacy against RSV lower respiratory tract disease in the first season, with data from over 37,000 participants across 22 countries including US sites. • This marks the second mRNA RSV vaccine approved after GSK's Arexvy, aiming to reduce 140,000-160,000 annual US hospitalizations among seniors; CDC review expected soon.

• Artivion (AORT) secured U.S. FDA approval for the NEXUS Aortic Arch System on April 7, 2026. • The device approval is expected to accelerate hospital adoption and spark reimbursement discussions. • This milestone positions Artivion for revenue growth in cardiovascular treatments.