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The Latest Breaking News from FDA

Sam Altman-Backed Arcadia Medicine Gets FDA Nod for Trials on 'Healthier' Ecstasy Formula

San Francisco biotech Arcadia Medicine, backed by Sam Altman, wins FDA nod to trial AM-1002, a safer MDMA variant to treat anxiety.

International Business Times UK

Company backed by Sam Altman gets FDA approval to trial ‘legal ecstasy’

Clinical trials of ‘safer MDMA’ could lead to new way of treating mental health problems, biotech firm says

The Independent UK

N.Y. Federal Court Upholds "Algorithmic Pricing Disclosure Act"

From Nat'l Retail Fed'n v. James, decided yesterday by Judge Jed Rakoff (S.D.N.Y.): [T]he Algorithmic Pricing Disclosure Act … provides… The post N.Y. Federal Court Upholds "Algorithmic Pricing Disclosure Act" appeared first on Reason.com.

Reason

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Original Zyn: FDA Failures Allow Fake Nicotine Pouches To Flood U.S. Market

By refusing to approve safer nicotine pouches, regulators have turned gas stations into gray markets for knockoffs.

Reason

Breakthrough Alzheimer’s Drug Could Reshape Senior Care

A new Alzheimer’s drug is offering hope where few options once existed. Recently approved by the FDA, it’s the first treatment shown to slow cognitive...

Saving Advice

Regeneron's Libtayo Gains FDA Approval To Reduce Recurrence Risk In Skin Cancer Patients

On Wednesday, the U.S. Food and Drug Administration (FDA) approved Regeneron Pharmaceuticals Inc.’s (NASDAQ:REGN) PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

Benzinga

Tempus AI's $100 Breakout — Billionaire Cliff Asness Reaps 60% Windfall

Tempus AI Inc (NASDAQ:TEM) has become one of 2025's most dramatic comeback stories. The stock soared past $100 this week, marking a new 52-week high and sending the market buzzing about the AI-powered cancer diagnostics company's growth prospects. Investors are taking note as the stock climbs amid recent FDA clearances…

Benzinga

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FDA Expands Johnson & Johnson Ulcerative Colitis Drug Approval To Pediatric Patients

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson Johnson’s (NYSE:JNJ) Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kg.

Benzinga

What's Going On Sarepta Stock On Wednesday?

Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock is trading higher on Wednesday, with apparently no news to justify the movement.

Benzinga

Kroger Pasta Salad Recall: URGENT Health Warning Issued Over Fears of Deadly Listeria Bug in Across 30 States

Kroger issues urgent recall of pasta salads sold in 30 U.S. states due to potential Listeria contamination, prompting health warnings and consumer alerts.

International Business Times UK

7 Things You Should Always Check on a Food Label—But Rarely Do

We all glance at calories and maybe check sugar, but most of us miss deep insights lurking on food labels. For shoppers aiming to eat smarter—especially with allergies, diet goals, or health conditions—those hidden metrics matter. By learning which seven things to always check, you’ll dodge misleading claims, spot hidden…

Grocery Coupon Guide

My Wife Took Tylenol While Pregnant—Should We Worry? Experts Explain

On September 22, 2025, President Donald Trump released a statement suggesting that Tylenol was linked to an increased risk of autism when used by pregnant mothers. He urged pregnant women to stop taking the drug. “Don’t take Tylenol,” Trump said. “Fight like hell not to take it.” On the same…

Clever Dude

Merck, Doctors Reject Proposal To Break Up Combined MMR Vaccine

A top U.S. health official's call to split the measles-mumps-rubella (MMR) vaccine into separate shots sparked strong pushback from Merck Co., Inc. (NYSE:MRK) and medical experts, who said such a move lacks scientific justification and could undermine immunization efforts.

Benzinga

This Emerging Biotech Stock Jumped 1,300% on Monday After Major FDA Breakthrough Milestone

Spruce Biosciences' stock surged to record highs after it received an FDA breakthrough designation for the TA-ERT candidate to treat a rare genetic disease.

International Business Times UK

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Benzinga

Adicet Bio's Lupus Trial Delivers 100% Response, Setting Stage For Phase 2

Adicet Bio Inc. (NASDAQ:ACET) shares fell Tuesday after the biotechnology company priced an $80 million direct offering, even as early safety and efficacy data from its Phase 1 trial of ADI-001 in autoimmune diseases showed encouraging signs.

Benzinga

EXCLUSIVE: Envoy Medical Cuts Capital Needs After FDA Approval For Final Trial Stage Of Cochlear Implant Trial

Envoy Medical Inc. (NASDAQ:COCH) announced on Tuesday that it has received U.S. Food and Drug Administration (FDA) approval to expand its pivotal clinical trial for the fully implanted Acclaim cochlear implant to the final stage, based on promising three-month data from the first 10 patients.

Benzinga

Spruce Biosciences (SPRB) Stock Jumps 30% After Hours Following Red Hot Rally On Monday: Here's Why

Spruce Biosciences Inc. (NASDAQ:SPRB) jumped to $175.00 during after-hours trading on Monday, up 34.20% or $44.60 from its closing price.

Grocery Coupon Guide

Here Are 10 Things You Need to Know About GMO Fruit

Whether you love them or avoid them, genetically modified fruits—better known as GMOs—have become impossible to ignore. From apples that don’t brown to papayas that resist disease, GMO fruit has quietly made its way onto grocery store shelves around the world. Yet confusion remains high, and misinformation spreads faster than…

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Kiplinger

What the Government Shutdown Means to Retirees

Depending upon how long it lasts, a government shutdown can impact your daily life, including seeing family, managing your health, and enjoying your free time.

The Independent UK

Kroger premade pasta salads sold in 28 states under recall over Listeria concerns

There have been no reports of illness stemming from the recall

Benzinga

AstraZeneca/Daiichi Sankyo Partnered Breast Cancer Drug Shows Survival Benefit Over Chemotherapy

AstraZeneca Plc (NASDAQ:AZN) and Daiichi Sankyo on Monday released high-level results from the TROPION-Breast02 Phase 3 trial.

MarketBeat

QURE: Why Analysts See Up to 63% Upside After 250% Single-Day Pop

Biotech stock uniQure just popped nearly 250% in one day, with an analyst calling its trial results "amazing". Wall Street sees significant upside to come.

Android Central

Samsung Galaxy Watches will 'soon' detect warning signs for heart failure

Apple made a splash with hypertension alerts; now Samsung will tackle its own serious health condition: Heart failure.

Tom’s Guide

I wore the Circular Ring 2 for three weeks and wanted to love it — but one big thing held it back

The Circular Ring 2 is a long-lasting, subscription-free smart ring with advanced, holistic tools like ECG readings, blood oxygen monitoring, and AFib detection but a buggy app limits its appeal for now.

The Guardian - US

Anti-abortion groups furious as FDA approves generic abortion pill

Abortion rights supporters hail win for evidence-backed medicine as Evita Solutions’ generic version of mifepristone given approval

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