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The Latest Breaking News from FDA

FDA Acceptance Of Rocket Pharmaceuticals' Lead Gene Therapy Application Reestablishes Momentum For Stock

On Tuesday, the U.S. Food and Drug Administration (FDA) accepted Rocket Pharmaceuticals, Inc.’s (NASDAQ:RCKT) resubmission of the Biologics License Application (BLA) for Kresladi (marnetegragene autotemcel; marne-cel), a lentiviral vector (LV)-based investigational gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I).

Benzinga

Telix Pharmaceuticals Enters Q4 On Strong Footing With Stabilized Pricing Pressures, Upgraded Annual Sales Guidance

Telix Pharmaceuticals (NASDAQ:TLX) updated on Tuesday its commercial and operational performance for the third quarter of fiscal 2025.

Benzinga

Simple blood test gets green light by FDA to improve early detection of Alzheimer’s disease

Millions of Americans are living with Alzheimer’s and hundreds of thousands are diagnosed each year

The Independent UK

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State urges residents to check freezers for radioactive shrimp after damning investigation into Indonesian farm

FDA has added to list of brands and products that may have been contaminated with cesium-137, a human-made radioactive substance that can cause cancer

The Independent UK

Why Congress Is Buying Intuitive Surgical Ahead of Earnings

Intuitive Surgical has attracted recent congressional buying ahead of its next quarterly earnings results, implying a new potential bull run

MarketBeat

Doritos and Cheetos are getting a makeover with ingredient change — and new flavor line

In addition to new recipes, PepsiCo hopes to introduce fresh packaging for its beloved snacks

The Independent UK

Depression-Focused GH Research Shares Could See Significant Upside: Analyst

Needham initiated coverage on Monday for GH Research PLC (NASDAQ:GHRS), citing the company’s lead drug candidate, GH-001, which had demonstrated impressive efficacy in Phase 2 versus competition.

Benzinga

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Why Is Scholar Rock Stock Trading Lower On Monday?

Scholar Rock Holding Inc. (NASDAQ:SRRK) stock is falling on Monday with a session volume of 8.19 million versus the average volume of 2.08 million, as per data from Benzinga Pro.

Benzinga

10 Foods That Interfere with Common Senior Medications

As people age, prescription use increases—but few realize that certain everyday foods can make those medications less effective or even dangerous. The Centers for Disease...

Saving Advice

FDA Adds New Warning For Johnson & Johnson's Cancer Cell Therapy

The Food and Drug Administration (FDA) has updated safety labeling for Johnson Johnson's (NYSE:JNJ) Carvykti after receiving reports of immune effector cell-associated enterocolitis (IEC-EC)—a rare but serious complication seen in both clinical trials and postmarketing data.

Benzinga

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

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

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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...

Benzinga

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

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.

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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.

International Business Times UK

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.

Grocery Coupon Guide

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…

Clever Dude

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…

Benzinga

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.

International Business Times UK

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.

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.

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