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The Latest Breaking News from FDA

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.

Benzinga

Major mac and cheese brand issues recall after eight reported incidents

The recalled pasta products contain undeclared ingredients

The Independent UK

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.

Tom’s Guide

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read the most diverse news in one place.

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

The Independent UK

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.

We Got This Covered

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

The Independent UK

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.

Benzinga

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

Health Secretary Robert F

The Independent UK

FDA Expands Approval For AstraZeneca's Drug For Pediatric Patients With Rare Type Of Cancer

On Wednesday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s (NASDAQ:AZN) Koselugo (selumetinib) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN), benign, nerve sheath tumors.

Benzinga

Johnson & Johnson's FDA-Approved Bladder Cancer Drug Offers New Option For Patients Avoiding Surgery

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson Johnson's (NYSE:JNJ) Inlexzo (gemcitabine intravesical system) as a new treatment approach for certain types of bladder cancer patients who need additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy).

Benzinga

Federal agents seize more than 600K illegal vapes in nationwide crackdown

Federal agents have seized illegal vaping products nationwide as the Trump administration cracks down on items often used by teens

The Independent UK

FDA Moves To Publicize Data On Pregnant Women's Covid Vaccine Side Effects

Top health officials under the U.S. Health and Human Services Secretary Robert F. Kennedy Jr. are intensifying efforts to gather and publicize data on potential harms caused by COVID-19 vaccines, particularly in pregnant women.

Benzinga

Apple Watches' hypertension alerts just put every smartwatch rival on notice

Every smartwatch brand wants to "save lives" and get people healthier. By detecting hypertension, Apple is making a major statement.

Android Central

Trump Moves To Rein In Misleading Pharmaceutical Ads With Stricter Regulations, Sidesteps Total Ban Proposed By RFK Jr.

President Donald Trump has signed an order to intensify regulations on direct-to-consumer drug advertisements. The administration has accused pharmaceutical companies of providing misleading information about medications and their side effects.

Benzinga

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Axios

Trump warns thousands of pharma companies over "deceptive ads"

The FDA said it's sending out 100 cease-and-desist letters and warning thousands of others over ads it says are "misleading."

Grocery Coupon Guide

10 Times Brands Promised “Lower Sugar” But Didn’t Deliver

We all celebrate when a product boasts “lower sugar,” thinking we’re making a healthier choice—only to be disappointed (and maybe even misled). The promise of sweetness with less cost to our health feels smart, but in many cases, it’s more marketing than truth. From sneaky labeling to lawsuits over deceptive…

Grocery Coupon Guide

What’s Behind the Sudden Rise in “Plant-Based” Labels—With No Plants?

Have you ever grabbed a product labeled “plant-based,” expecting something leafy, only to find it’s greenwashed marketing—not actual plants? You’re not alone. The trend of plant-based labels with no plants is growing fast and causing plenty of confusion for shoppers. Understanding why this happens—from marketing spin to lax regulation—can help…

Fortune

Tylenol maker's stock lost billions after a rumor linking the medicine to autism. Wall Street says buy the dip as one bank sees a 'major overreaction'

Canaccord Genuity went on social media to gauge the reaction. Even the MAHA crowd was mixed on this one.

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Roll Call

Broad ‘MAHA’ proposal largely calls for studies, awareness - Roll Call

The Trump administration on Tuesday presented a "Make America Healthy Again" plan to tackle rising chronic disease.

Benzinga

Ionis Pharmaceuticals To Expedite Development Of Rare Neurological Disease Candidate With FDA Breakthrough Status

On Tuesday, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Ionis Pharmaceuticals Inc.’s (NASDAQ:IONS) ION582 for Angelman syndrome (AS), a rare neurological disorder.

Evening Standard

Soap, deodorant and sanitiser recalls over sepsis concerns - full list revealed

Customers are eligible for a full refund

Reason

Advocates of MDMA-Assisted Psychotherapy Complain that 'the FDA Moved the Goalposts'

The agency's puzzling concerns about the Lykos Therapeutics drug application

The Guardian - US

As Covid surges in the US, Americans can’t get vaccinated: ‘terrified I might kill somebody’

The FDA is allowing the vaccine for people 65 and older, but younger people need to have an underlying condition

Benzinga

FDA To Expedite Nicotine Pouch Reviews In Pilot Program Under Trump Pressure: Report

The U.S. Food and Drug Administration (FDA) is reportedly set to launch a pilot program to fast-track the review of nicotine pouches from four major tobacco companies amid mounting pressure from the Trump administration.

Benzinga

FDA Tightens Grip On Safe Weight Loss Drugs, WHO Adds Them To Essential Medicines List

The U.S. Food and Drug Administration on Friday established a "green list" import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market.

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