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The Latest Breaking News from FDA

FDA Approves Xocova (Ensitrelvir): The First Oral COVID Pill You Take After Exposure — Before You Get Sick

Xocova (ensitrelvir) is the first FDA-approved oral COVID post-exposure pill, cutting risk by 67% in the SCORPIO-PEP Phase 3 trial. What high-risk patients need to know.

Medical Daily

A Smart Ring That Diagnoses Sleep Apnea at Home with 97% Accuracy Just Got FDA Cleared — Here's How It Works

The FDA-cleared Happy Ring diagnoses sleep apnea at home with 97% accuracy. Up to 30M Americans have undiagnosed OSA. Here's what this means for your health.

Medical Daily

The FDA Just Put Psilocybin and an MDMA-Like Drug on a 1-to-2 Month Approval Track. A Historic Mental Health Decision Is Coming.

FDA issued National Priority Vouchers to Compass Pathways, Usona, and Transcend for psilocybin and methylone in April 2026. A decision could come by late 2026.

Medical Daily

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Hepatitis Delta Is the Deadliest Form of Viral Hepatitis — and the U.S. Just Got Its First Treatment for It

FDA granted accelerated approval to Hepcludex (bulevirtide) for Hepatitis Delta on May 22, 2026 — the first-ever U.S. treatment for HDV. What patients need to know.

Medical Daily

Nara Organics Baby Formula Recalled After 3 Infants Hospitalized with Botulism in California, Pennsylvania, and Washington

FDA and CDC link 3 infant botulism cases to Nara Organics formula sold at Target. All lots recalled. Learn what parents must do now.

Medical Daily

Superfood Supplement Powder Linked to Active Multistate Salmonella Outbreak, Exposing Health Risks Many Buyers Do Not Know About

FDA updated its moringa leaf powder Salmonella outbreak investigation (ref #1358) on June 3, 2026, adding recalled products. The multistate outbreak has 88% of interviewed victims reporting moringa consumption. Products include Live It Up Super Greens and Why Not Natural Moringa capsules. Here is the consumer warning.

Medical Daily

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

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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

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

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

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AAP

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).

Medical Daily

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.

The Independent UK

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

Medical Daily

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.

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The Independent UK

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

AAP

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

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.

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.

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