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The Latest Breaking News from FDA

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

From analysis to the latest developments in health,
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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

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.

Benzinga

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

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The Independent UK

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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

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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The Independent UK

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

Health Secretary Robert F

Benzinga

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).

The Independent UK

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

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Benzinga

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.

Android Central

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.

Benzinga

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.

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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