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The Latest Breaking News from FDA

Science history: A tragic gene therapy death that stalled the field for a decade — Sept. 17, 1999

Sept. 17, 1999: Jesse Gelsinger died after receiving a gene therapy treatment to treat a liver disease. The death sparked an investigation and caution around gene therapy, which ultimately stalled the field for years.

LiveScience

FDA Flags Eli Lilly's Weight-Loss Drug Video For Misleading Claims

The U.S. Food and Drug Administration (FDA) has determined that a promotional video featuring Zepbound and Mounjaro (tirzepatide), both produced by Eli Lilly And Co. (NYSE:LLY), is false or misleading.

Benzinga

Hims & Hers Scrutinized For Marketing Its Product As Similar To Ozempic, Wegovy

Hims Hers Health Inc. (NYSE:HIMS) stock is trading lower on Tuesday. The U.S. Food and Drug Administration (FDA) issued a warning letter to Hims Hers Health, dated Sept. 9, addressed to the company’s CEO, Andrew Dudum.

Benzinga

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Enhanced Games athletes can dope to compete for US$1 million prizes. But at what cost to sport?

Olympic swimmer Ben Proud has become the first British athlete to join the Enhanced Games – a controversial new event that allows athletes from all over the world to compete using performance-enhancing drugs. The prize money on offer can hit US$1 million (£730,000). But the swimmer, who won a silver…

The Conversation

US health officials to revisit vaccine policies using anti-vax tactics, experts warn

Data public health experts say is worrisome will reportedly be presented to ACIP later this week before vote on shots

The Guardian - US

FDA takes aim at Hims and other telehealth services in drug advertising blitz

The Trump administration has issued its first warnings to online services that offer unofficial versions of popular drugs like the blockbuster obesity treatment Wegovy

The Independent UK

Moderna Reports 8-Fold Jump In Antibodies With Updated Spikevax

Moderna Inc. (NASDAQ:MRNA) on Tuesday released preliminary immunogenicity data for the 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.

Benzinga

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Adial Pharmaceuticals Highlights Favorable Comments From FDA Meeting For Lead Program In Alcohol Use Disorder

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) on Tuesday received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held in July.

Benzinga

What Is TikTok's Benadryl Challenge? Teen Almost Dies After Attempting Viral Trend

TikTok's Benadryl Challenge resurfaces after a teen's near-death overdose. FDA and doctors warn of severe health risks from the dangerous trend.

International Business Times UK

EXCLUSIVE: Scienture Secures PBM-Led Rebate Agreement To Position Hypertension Drug For Rapid Adoption In US Market

Scienture Holdings, Inc. (NASDAQ:SCNX) on Tuesday announced that it has formalized a commercial Pharmacy Benefit Manager (PBM) led Group Purchasing Organization (GPO) rebate agreement, advancing the process of securing formulary access with health plans covering more than 100 million lives for Arbli (losartan potassium) Oral Suspension, 10 mg/mL.

Benzinga

Confused About the New COVID Vaccine and Medicare? What You Need to Know

Getting the new COVID-19 vaccine covered by Medicare isn't as easy this year as it was in the past. Here's what you need to know before you take a trip to your pharmacy.

Kiplinger

FDA Expands Krystal Biotech Vyjuvek's Label Allowing Newborns Access To Gene Therapy For Blistering Skin

The U.S. Food and Drug Administration (FDA) on Monday approved Krystal Biotech, Inc.’s (NASDAQ:KRYS) label update for Vyjuvek (beremagene geperpavec-svdt).

Benzinga

ATyr Pharma Stock Sinks, Plans FDA Review After Mixed Phase 3 Results

Biotech firm aTyr Pharma Inc. (NASDAQ:ATYR) plummeted over 81% at last check on Monday, with a session volume of 34.7 million compared to the average volume of 4.83 million as per data from Benzinga Pro.

Benzinga

FDA Approves Hypertension Alerts On Apple Watch, iPhone Air's Chinese Launch Delayed And More: This Week In Appleverse

It was an eventful week for Apple Inc. (NASDAQ:AAPL), with significant developments in the tech giant’s product line and regulatory approvals. Here’s a quick look at the key stories that unfolded over the weekend.

Benzinga

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Benzinga

Palantir Co-Founder Rips Intel Deal, Apple Watch Wins FDA Nod, iPhone Air Stalls In China — This Week In Tech

The past week has been a whirlwind of tech news, with major players like Palantir Technologies, Intel Corp, and Apple Inc. making headlines. From concerns over government equity stakes to new health features on smartwatches, the tech industry continues to evolve and surprise.

Benzinga

Hims & Hers Faces FDA Heat As Commissioner Martin Makary Calls Out Super Bowl Ad For Hiding Drug Risks

Food and Drug Administration Commissioner Martin Makary stated on Friday that Hims Hers Health Inc. (NYSE:HIMS) broke federal law with its Super Bowl commercial promoting weight-loss drugs.

The Independent UK

Trump officials plan to tie Covid vaccines to child deaths at upcoming CDC meeting

IN FULL

Benzinga

FDA Gives Green Light To Hypertension Alerts On Apple Watch

On Tuesday, Apple Inc. (NASDAQ:AAPL) introduced Apple Watch Ultra 3. The company said Apple Watch Ultra 3 can be pre-ordered today, with availability beginning Friday, Sept. 19.

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The Independent UK

Major mac and cheese brand issues recall after eight reported incidents

The recalled pasta products contain undeclared ingredients

Tom’s Guide

This new Apple Watch health feature is a game-changer — and it just got FDA clearance

The Apple Watch’s new hypertension detection feature has won FDA clearance in time for the launch of the Series 11, and will arrive on watches next week.

The Independent UK

Apple gets official approval for watch feature that can spot potentially fatal problem

Tool will come to new watches announced this week – but some old ones, too

We Got This Covered

RFK Jr. sends ‘thousands of letters’ to drug companies over ‘misleading’ ads that ‘distorted physician prescribing habits’

Those happy pill ads with dancing patients? Trump's administration says they're basically lying to you.

The Independent UK

Over 22,000 juice pouches part of elevated recall over potentially harmful bacteria contamination

The recall has been declared a Class II by the FDA

Benzinga

Travere Shares Are Trading Higher Wednesday: What's Going On?

Travere Therapeutics, Inc. (NASDAQ:TVTX) shares are trading higher on Wednesday after the company announced that it was informed by the FDA that an advisory committee is no longer needed following further review of its supplemental New Drug Application (sNDA) for FILSPARI in focal segmental glomerulosclerosis.

The Independent UK

Trump's plan for a drug advertising crackdown faces many hurdles

Health Secretary Robert F

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