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The Latest Breaking News from FDA

Texas A&M Scientists Unlocked the Human Body's Hidden Ability to Regrow Bone and Joints — Using Two Already-Approved Signals

Texas A&M / Nature Communications June 17, 2026: FGF2 + BMP2 sequential treatment regrew bone, joint, cartilage, and ligaments in mice that normally scar. What it means for medicine.

Medical Daily

FDA panel backs first-of-its-kind flu vaccine using mRNA technology

A new kind of flu vaccine is moving a step closer to the U.S. market

AAP

uniQure Stock Looks Drastically Undervalued After Upbeat FDA Meeting

uniQure stock looks poised to soar over the long term, but it does pose meaningful risk.

Barchart

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Nearly 370,000 bottles of duloxetine have been recalled in the US due to elevated levels of a potentially cancer-causing impurity.

International Business Times UK

FDA Advisory Panel Votes Today on First mRNA Flu Vaccine as MFLUSIVA Phase 3 Results Face Intense Scrutiny

FDA VRBPAC votes June 18 on Moderna's MFLUSIVA — the first mRNA flu vaccine. Phase 3 showed 26.6% RVE vs. standard dose; 47.9% vs. healthcare outcomes. PDUFA August 5, 2026.

Medical Daily

FDA panel considers a first-of-its-kind flu vaccine using mRNA technology

U.S. health advisers are debating a new kind of flu vaccine

AAP

New mRNA flu vaccine faces scrutiny ahead of key FDA decision

U.S. health advisers are debating a new kind of flu vaccine

The Independent UK

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How the FDA Created a Peptide Black Market

Because the agency has banned most peptides, products from overseas labs dominate the market. How does that protect Americans?

Reason

Exclusive: A 21-year-old Stanford grad just raised $11 million to put a hormone lab on your wrist

As Oura and WHOOP expand into women's health, startup Clair Health has raised $11 million to build a wearable designed from the ground up to continuously model hormonal cycles.

Fortune

CDC Activates Emergency Operations Center Following New World Screwworm Detection in Texas as Experts Assess Potential Threats to Humans

CDC activated emergency operations June 16 for New World screwworm in Texas and New Mexico. 12 animal cases confirmed. Human risk low but real. What to watch for.

Medical Daily

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

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

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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

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…

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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…

International Business Times

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.

The Independent UK

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

Medical Daily

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.

International Business Times UK

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.

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).

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