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The Latest Breaking News from FDA

RFK Jr hints access to key abortion drug could be cut back

Health secretary claims Biden officials ‘twisted the data’ despite research showing mifepristone is safe and effective

The Guardian - US

FDA Breakthrough Status Awarded To Lilly-Merck Combo Drug For Advanced Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) on Thursday granted Breakthrough Therapy designation to Eli Lilly and Co.’s (NYSE:LLY) olomorasib, in combination with Merck Co. Inc.’s (NYSE:MRK) anti-PD-1 therapy Keytruda (pembrolizumab), for the first-line treatment of unresectable advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation…

Benzinga

FDA Confirms Direct Review Path For Aquestive's Allergy Treatment

The U.S. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc. (NASDAQ:AQST) that an advisory committee meeting is not required for Anaphylm (dibutepinephrine) Sublingual Film.

Benzinga

From analysis to the latest developments in health,
read the most diverse news in one place.

Texas Legislature Passes ‘Bounty Hunter’ Ban on Abortion Pills

House Bill 7 attacks one of the last remaining options for reproductive care in Texas and declares legal war on blue states.

Texas Observer

LSD shows promise for reducing anxiety in drugmaker's midstage study

A midstage study of the psychedelic drug LSD showed positive results for easing symptoms in people with generalized anxiety disorder

The Independent UK

FDA Delays Decision On Agios Pharmaceuticals' Blood Disorder Drug For Expanded Use

On Thursday, the U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for Agios Pharmaceuticals, Inc.’s (NASDAQ:AGIO) supplemental New Drug Application (sNDA) of Pyrukynd (mitapivat) for adult patients with non-transfusion-dependent (NTD) and transfusion-dependent (TD) alpha- or beta-thalassemia by three months to December 7, 2025.

Benzinga

Forget vapes: Nicotine pouch startup Sesh raises $40 million from 8VC, Post Malone, and Diplo to take on Zyn

Founder Max Cunningham is hoping to reshape U.S. nicotine consumption through his venture-backed startup.

Fortune

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Florida Chooses 'Medical Freedom' As State Plans To End Vaccine Mandates, Even For Schools: Experts Warn Of 'Major Disaster' (CORRECTED)

Editor’s Note: This article has been updated to reflect the correct year-to-date performance of Moderna stock.

Benzinga

Scientists say there is no link between ‘microdosing’ weight-loss drugs and living longer

It is ‘too early’ to know whether small doses of weight-loss drugs can help you live longer, experts say

The Independent UK

FDA Official Pressures YouTube Into Removing a Channel For Posting His Own Vaccine Comments

Not long ago, conservatives were rightly concerned about jawboning. Now they're apparently happy to take part in it themselves.

Reason

Texas sued over its lab-grown meat ban

Two California-based companies accuse the state of government overreach for banning the sale of their products for the next two years.

The Texas Tribune

After Copycat Boom, China's Drugmakers Target Global Generics

China-based drugmakers that once fueled a surge of copycat weight-loss treatments in the U.S. are now pivoting to generics of Novo Nordisk‘s (NYSE:NVO) Wegovy and Eli Lilly's (NYSE:LLY) Zepbound as regulators tighten rules on compounded medicines.

Benzinga

Illegal products from China seized at Bangkok warehouses

Consumer protection police raided two warehouses in Bangkok’s Bang Khun Thian district and seized goods smuggled from China worth over 10 million baht.

Bangkok Post

RFK Jr critic Paul Offit removed from FDA vaccine advisory committee

Offit, long-serving vaccine scientist, says he was not given a reason for dismissal after initially being offered extension

The Guardian - US

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The Guardian - US

What you need to know about Covid vaccines in the US this fall

In a move praised by RFK Jr, the FDA approved a new shot, but only for some people – here’s what to know about who can get them, and where

Grocery Coupon Guide

6 Snack Brands Being Recalled for “Undeclared Allergens”

An undeclared allergen is one of the most serious and common reasons for a food recall. A simple mistake on the ingredient label can have life-threatening consequences for a person with a severe food allergy. In 2025, the FDA has already issued numerous recalls for popular snack foods that were…

The Mary Sue

‘Her entire body swelled up’: Pennsylvania woman feeds dog grain-free food. Then her dog has heart failure

Imagine shelling out extra money to give your pet the “best of the best,” only to learn the food could be the very thing harming them.

Benzinga

Why Is United Therapeutics Stock Rallying On Tuesday?

United Therapeutics Corporation (NASDAQ:UTHR) released data on Tuesday from its TETON-2 study evaluating the use of nebulized Tyvaso (treprostinil) Inhalation Solution for idiopathic pulmonary fibrosis (IPF).

Get all your
news in one place.

100's of premium titles.
One news app.

Benzinga

Johnson & Johnson Showcases Positive AFib Data, Treatment Results

Johnson Johnson (NYSE:JNJ) reported new cardiovascular data at the 2025 European Society of Cardiology Congress.

Benzinga

Ionis Pharma's Investigational Drug Shows Promise For Triglyceride And Pancreatitis Reduction

Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) on Tuesday released topline results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen for severe hypertriglyceridemia (sHTG).

Benzinga

Trump Demands Pfizer, Other Covid Drug Makers To 'Justify The Success,' Show Their Results Amid New FDA Restrictions

President Donald Trump has called for pharmaceutical companies to provide evidence of the effectiveness of their COVID-19 drugs.

Grocery Coupon Guide

8 Expiration Dates That Are Just Marketing Tricks

The expiration date on a product seems like a strict safety deadline. In reality, most of these dates are not regulated by the FDA. They are a manufacturer’s best guess for peak quality. Some companies use these dates as a marketing trick. The goal is to encourage you to throw…

The Guardian - US

Trump news at a glance: US president issues threat to mandate voter ID

Donald Trump says he will issue an executive order to ensure every single vote will require identification, a move that could affect millions. Key US politics stories from Sunday 31 August at a glance

The Guardian - US

Top FDA official demands removal of YouTube videos in which he criticized Covid vaccines

Channel was an attempt to ‘preserve’ what officials in current Trump administration said during the pandemic

Al Jazeera

Who can get updated COVID-19 vaccines in the US now?

FDA has approved COVID shots for people aged 65+ and at high risk; others need a doctor’s order.

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