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The Latest Breaking News from FDA

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 · Sep 16, 2025

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 · Sep 16, 2025

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 · Sep 16, 2025

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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 · Sep 16, 2025

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 · Sep 15, 2025

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 · Sep 15, 2025

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 · Sep 15, 2025

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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 · Sep 14, 2025

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 · Sep 14, 2025

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 · Sep 13, 2025

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

IN FULL

The Independent UK · Sep 13, 2025

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 · Sep 12, 2025

Major mac and cheese brand issues recall after eight reported incidents

The recalled pasta products contain undeclared ingredients

The Independent UK · Sep 12, 2025

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 · Sep 12, 2025

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The Independent UK · Sep 12, 2025

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 · Sep 10, 2025

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 · Sep 10, 2025

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 · Sep 10, 2025

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.

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The Independent UK · Sep 10, 2025

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

Health Secretary Robert F

Benzinga · Sep 10, 2025

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 · Sep 10, 2025

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 · Sep 10, 2025

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

Benzinga · Sep 10, 2025

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 · Sep 10, 2025

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 · Sep 10, 2025

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.

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