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The Latest Breaking News from FDA

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.

Medical Daily

The First Lyme Disease Vaccine in 24 Years Just Passed Its Pivotal Phase 3 Trial with 74 Percent Efficacy — and It Is for Children Too

Pfizer and Valneva announced Phase 3 VALOR trial results for Lyme disease vaccine PF-07307405 on March 23, 2026: 73.2–74.8% efficacy in ages 5 and older. Regulatory submissions planned for 2026. No Lyme vaccine has been available in the U.S. since 2002.

Medical Daily

Frozen pizza product recalled in 21 states over possible presence of metal fragments

The US Food and Drug Administration elevated the recall to Class II, which means the product can pose a serious health risk

The Independent UK

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FDA Set to Rule on First New Smoking Cessation Drug in 20 Years: Cytisinicline Decision Due June 20

Cytisinicline, a plant-based alkaloid for smoking cessation, has an FDA PDUFA date of June 20, 2026 — 8 days away. If approved, it would be the first new quit-smoking drug in 20 years. Phase 3 ORCA-2 and ORCA-3 trials showed significantly higher quit rates than placebo.

Medical Daily

Americans Are Still in Nebraska Quarantine from the Cruise Ship Hantavirus Outbreak. Here Is the Latest on the Most Unusual U.S. Health Emergency of 2026.

The CDC's June 11, 2026 situation update on the M/V Hondius Andes hantavirus outbreak: 10 Americans remain at the Nebraska Quarantine Unit, 8 have returned home for monitoring, and a separate Washington State hantavirus case has been reported. Full timeline and what it means for travelers.

Medical Daily

Autistic children being injected with unapproved stem cell treatments supported by RFK Jr

Desperate US parents paying up to $20,000 a session for a procedure scientists say could be bogus

The Guardian - US

‘Autistic kids are being experimented on’: inside America’s booming market for unproven stem cell infusions

Feeling abandoned and overwhelmed, families are turning to controversial new therapies backed by the US health secretary

The Guardian - US

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Instant ramen cafe raided for selling expiring, illegally imported noodles

NAKHON RATCHASIMA – A search of a popular imported instant ramen cafe in Mueang district revealed that nearly half of the store’s products were smuggled or illegally imported, lacked FDA approval and were nearing expiration.

Bangkok Post

Frozen Pizza Recall Hits 21 States as FDA Took Three Weeks to Classify Metal Risk in Popular Kids' Snack

Farm Rich Pizza Cheese Crunchers recalled in 21 states over metal pieces. The FDA took three weeks to classify the risk in the popular kids' frozen snack. Check your lot number now.

International Business Times UK

Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s why

Dabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data integrity lapses. The company said the impact is limited to a small portion of operations, while broader business and domestic sales remain unaffected.

The Economic Times

A Blood Test That Detects Alzheimer's Disease Years Before Brain Scans Can Just Took a Major Leap Forward — Harvard Study Confirms It Outperforms PET Imaging in Early Detection

Harvard Mass General Brigham study in Nature Communications (April 2026): plasma pTau217 blood test detects Alzheimer's progression years before PET scans. FDA already cleared Lumipulse pTau217 test for symptomatic patients.

Medical Daily

The Antibiotic Last Line of Defense Against Gonorrhea Just Lost More Ground: WHO Data Shows Sixfold Resistance Rise and U.S. Is Running Out of Options

WHO EGASP data show ceftriaxone resistance in gonorrhea rose more than sixfold globally from 2022 to 2024. Ceftriaxone is the only U.S.-recommended gonorrhea treatment. New pipeline drugs show promise but are not yet approved.

Medical Daily

US drug regulator issues import alert for drugs made at a Dabur India plant

The US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed significant issues with data integrity and factory maintenance. Critical manufacturing records were reportedly falsified. Live birds and droppings were also found in a raw material warehouse.

The Economic Times

FDA issues new kidney warning for weight loss pill

Alli was the first over-the-counter weight loss pill approved by the U.S. Food and Drug Administration

The Independent UK

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AAP

FDA's e-cigarette authorization: Fruity vapes not significantly better than tobacco ones

A new memo from U.S. health regulators is raising questions about a recent decision to authorize the first fruit-flavored e-cigarettes for adult smokers

The Independent UK

FDA memo reveals fruit-flavored e-cigarettes aren’t better for quitting smoking

The six-page FDA memo suggests regulators sidestepped previous concerns about the risks associated with sweet vaping flavors

Medical Daily

A 1,000-Year-Old Chinese Herb Just Passed Modern Scientific Scrutiny for Hair Loss

A 2026 review in the Journal of Holistic Integrative Pharmacy confirms Polygonum multiflorum (He Shou Wu) combats hair loss through four simultaneous biological mechanisms: DHT blocking, follicle regeneration signaling, anti-apoptosis, and improved scalp circulation.

Medical Daily

AI Is Now Detecting Cancer Years Before Doctors Can — New 2026 Research Shows How Machine Learning Is Transforming Diagnosis

A 2026 Nature Cancer AI identified 18 cancer types with high accuracy from minimal slides. A Mayo Clinic AI detected pancreatic cancer up to 3 years before diagnosis — nearly doubling specialist rates.

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Medical Daily

Alzheimer's Treatment Is Entering a New Era — Here Is Everything That Has Changed in 2026

Leqembi and Kisunla are slowing Alzheimer's decline by 27-35% in early-stage patients. The 2026 drug pipeline has 158 candidates in 192 trials. Prevention trials are beginning. Here's the full update.

Reason

The FDA Finally Approved a New Sunscreen Ingredient. It Only Took Over 25 Years.

The FDA's burdensome regulatory process has throttled sunscreen innovation.

Medical Daily

Finerenone Kidney Drug Shown to Protect Heart and Kidneys in Millions More Patients After Three Major 2026 Studies

Three major studies published in NEJM, JAMA, and The Lancet in June 2026 show finerenone protects kidneys and hearts in non-diabetic CKD patients, expanding its potential reach to millions.

The Independent UK

Pet food recall expands to 20 US states amid concerns over serious neurological symptoms

Product could have potentially low levels of Vitamin B1, which is essential for ‘neurologic function in both cats and dogs’

Medical Daily

Medicare Is About to Cover Weight-Loss Drugs for the First Time — Here's What the GLP-1 Bridge Program Means for Millions of Americans with Obesity

Medicare's GLP-1 Bridge launches July 1, 2026, offering eligible Part D enrollees Wegovy and Zepbound for $50/month — the first-ever Medicare coverage for obesity-specific GLP-1 drugs.

Medical Daily

FDA Approves Bemotrizinol: First New Sunscreen Ingredient in 25 Years to Hit U.S. Market in 2026

The FDA approved bemotrizinol on June 9, 2026 — the first new sunscreen ingredient in the U.S. in more than 25 years. It provides superior UVA protection already used worldwide.

Medical Daily

Two Breakthrough Treatments Are Changing the Outlook for Americans with Treatment-Resistant Depression

New 2026 clinical data on Caplyta and Spravato offer major new hope for the roughly 7 million Americans with treatment-resistant depression. Here's what the evidence now shows.

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