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The Latest Breaking News from FDA

Personalized mRNA Cancer Vaccine Shows Five-Year Data Stunning Oncologists with 69 Percent of Stage III IV Melanoma Patients Cancer-Free

ASCO 2026 (June 3, 2026) and Journal of Clinical Oncology: Intismeran autogene + Keytruda shows 49% sustained recurrence reduction at 5 years, 59% distant metastasis reduction, and 53% overall survival benefit in high-risk Stage III/IV melanoma. 69% of combination patients are cancer-free at 5 years.

Medical Daily

Parasite That Causes Weeks of Severe Diarrhea Hits Peak Season in the United States Amid Active Outbreak Investigation

The FDA is actively investigating a Cyclospora (cyclosporiasis) outbreak with an unknown source as case counts increase in summer 2026. Cyclospora is a microscopic parasite linked to leafy greens, cilantro, basil, and other fresh produce. Summer is peak season. Here is the warning every American needs before reaching for the…

Medical Daily

Deadly Listeria Outbreak Linked to Soft Cheese May Have Circulated in the U.S. Food Supply for Three Years Undetected, and the Contaminated Batch's Sell-By Date Was Yesterday

A Listeria outbreak linked to Clover Hill Dairy requesón/soft ricotta cheese has killed 1 and hospitalized 8 across Maryland, New York, and Virginia. Illness samples date to March 2023 — a potential 3-year undetected contamination. The contaminated batch had a sell-by date of June 14, 2026. Maryland has suspended the…

Medical Daily

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Psychedelics for Mental Health: Inside the 2026 Boom

Nushama, a riff on the Hebrew word for soul, treats mostly treatment-resistant patients, many of them heavily medicated and numbed out, using IV ketamine and Spravato.

International Business Times

More than 500,000 mac and cheese packages sold at Aldi recalled in the US over undeclared allergens

The FDA upgraded the recall to a Class II, which means that eating the product can pose a serious health risk

The Independent UK

First Needle-Free Epinephrine for Anaphylaxis Enters Real-World Clinical Use, Transforming Emergency Treatment for 32 Million Americans with Food Allergies

Neffy (epinephrine nasal spray), approved by the FDA in August 2024, is now in real-world clinical use as the first needle-free treatment for anaphylaxis. With summer outdoor activities creating an elevated allergy risk, here is why this device-free option is transforming emergency care for millions.

Medical Daily

Chikungunya Hits Mauritius as the CDC Now Has Four Simultaneous Active Outbreaks Listed — the Widest Multi-Country Chikungunya Warning Since 2014

CDC issued a new chikungunya travel notice for Mauritius on May 14, 2026 — now the fourth simultaneous active chikungunya outbreak notice alongside Suriname, French Guiana, and Mayotte. The FDA-approved Ixchiq vaccine is available but widely underutilized. Here is the full warning.

Medical Daily

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Raw Milk Tycoon Earning $30M a Year Admits He Has Put Children in Hospital While Calling Himself a 'Pioneer'

Mark McAfee's raw milk business thrives despite multiple health outbreaks and legal challenges, with federal support and consumer demand driving continued success.

International Business Times UK

Halia Therapeutics Receives FDA Fast Track Designation for Ofirnoflast (HT-6184) in Lower-Risk Myelodysplastic Syndromes

LEHI, Utah, June 15, 2026 /PRNewswire/ -- Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company developing first-in-class therapies targeting inflammasome-driven disease biology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ofirnoflast (HT-6184) for the treatment of adult patients with lower-risk myelodysplastic syndromes (LR-MDS).

AAP

Stanford Scientists Unveil Breakthrough That Could Eliminate the Need for Knee Replacements by Regrowing Cartilage with a Single Injection

Stanford Medicine published a landmark study in Science (June 12, 2026) showing that blocking the aging enzyme 15-PGDH completely reverses cartilage loss in old mice, prevents post-injury arthritis, and regenerates human knee tissue from replacement surgeries. Here is the full breakthrough.

Medical Daily

Alfredo sauce sold in 41 states recalled at ‘highest risk’ level over potential salmonella contamination

A dry milk powder ingredient in the sauce is potentially contaminated with the deadly bacteria

The Independent UK

Chikungunya Outbreaks Are Now Active in Three Different Countries and Territories Simultaneously — and Summer Travelers Are at Risk from the Caribbean to the Indian Ocean

Active CDC travel notices cover chikungunya outbreaks in Suriname (Feb 2026), Mayotte (March 2026), and French Guiana (June 4, 2026). The FDA-approved Ixchiq vaccine is available but underused. Here is everything summer travelers to the Caribbean and Indian Ocean need to know.

Medical Daily

Baby formula sold at Target is recalled across the US after multistate botulism outbreak

Infant botulism is a rare but serious illness that occurs in babies under age 1

The Independent UK

Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak

Nara Organics has recalled its organic baby formula sold at Target stores and online due to a multistate outbreak of infant botulism

AAP

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Medical Daily

First-in-Class Drug Targeting Treatment-Resistant High Blood Pressure Wins FDA Approval — and Works Like No Existing Drug

FDA approved baxdrostat (Baxfendy) on May 18, 2026 as the first-ever oral aldosterone synthase inhibitor for uncontrolled and resistant hypertension. BaxHTN Phase 3 (NEJM 2025): 8.7–9.8 mmHg additional systolic blood pressure reduction added to background therapy. Here is the full story.

The Independent UK

How parents can talk to their kids about vaping as FDA authorizes some flavored e-cigarettes

Nearly 6% of U.S. middle and high school students vape

Medical Daily

A New Antibiotic That Defeats Superbugs Just Received FDA Approval for Dangerous Drug-Resistant Urinary Tract Infections

FDA approved Zaynich (cefepime and zidebactam) on May 29, 2026 for complicated urinary tract infections caused by drug-resistant Gram-negative pathogens. ENHANCE-1 Phase 3 trial showed superiority to meropenem at test of cure. Here is how it works and who benefits.

Medical Daily

CRISPR Gene Editing Achieves a Functional Cure for Sickle Cell Disease in 96 Percent of Patients — RUBY Trial Results in the New England Journal of Medicine Are Historic

The RUBY Trial (NEJM, April 2026): CRISPR-Cas12a gene editing therapy reni-cel (renizgamglogene autogedtemcel) achieved a functional cure in 27 of 28 (96%) severe sickle cell disease patients, with no painful crises for up to two years after treatment. Led by Dr. Rabi Hanna at Cleveland Clinic.

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Medical Daily

Counterfeit Botox Injections Are Sending People to Hospitals in Multiple U.S. States — and the CDC Warns the Risk Is Ongoing

The CDC has an active warning about harmful and potentially fatal reactions from counterfeit Botox and mishandled botulinum toxin injections, documented across multiple U.S. states. A 2024 investigation found 22 hospitalizations, including 4 on ventilators. The CDC warning remains active in 2026.

Medical Daily

Alzheimer's Disease Is No Longer Untreatable: A 2026 Guide to the Blood Tests, Drugs, and Prevention Strategies That Are Changing the Future for 7 Million Americans

A comprehensive June 2026 guide to Alzheimer's prevention and treatment: two FDA-approved disease-modifying drugs (lecanemab/Leqembi, donanemab/Kisunla), an FDA-cleared blood test (Lumipulse pTau217), and the lifestyle interventions with the strongest prevention evidence.

Medical Daily

Lassa Fever Nigeria 2026: 663 Confirmed Cases, 167 Deaths, 25 Percent Fatality Rate as US Healthcare Experts Issue Urgent Warning to Travelers

Nigeria's 2026 Lassa fever outbreak: 663 confirmed cases, 167 deaths, 25.2% case fatality rate — up from 18.5% last year — across 22 states. 39 healthcare workers infected. NETEC warns U.S. clinicians to increase suspicion in returning travelers. Here is what patients and providers need to know.

Medical Daily

ByHeart Infant Formula Botulism Outbreak Post-Investigation 2026: Root Cause Still Unidentified Despite Genetic Match to Milk Powder Supplier

The FDA and CDC declared the ByHeart infant formula botulism outbreak over on February 26, 2026 after 48 infants were sickened across 17 states. A June 10, 2026 Food Safety Magazine investigation reveals the root cause remains unidentified despite genetic matches to organic whole milk powder. New testing protocols are…

Medical Daily

AI Outpaces Trust in Healthcare as Patients and Doctors Struggle to Keep Up, 2026 Study Finds

The 2026 Future Health Index found AI is transforming clinical care, but trust gaps among doctors and patients are slowing adoption and threatening patient safety.

Medical Daily

Eli Lilly's $2.75 Billion AI Bet on Anti-Aging Drugs Signals a Major Shift in Pharmaceutical Priorities

Eli Lilly's $2.75B AI deal with Insilico Medicine targets age-related diseases. How AI is transforming longevity drug discovery and what it means for patients.

Medical Daily

FDA Clears First Human Epigenetic Reprogramming Trial in U.S. — What the Harvard-Backed Anti-Aging Therapy Could Mean for You

Harvard-backed Life Biosciences has received FDA clearance for the first-ever human epigenetic reprogramming trial. Here's what it targets and why it matters.

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