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The Latest Breaking News from FDA

Regenxbio Unveils 12-Month Data For Gene Therapy Soon After FDA Delays Review Date

On Friday, REGENXBIO Inc. (NASDAQ:RGNX) shared new data from the Phase 1/2/3 CAMPSIITE trial of clemidsogene lanparvovec (RGX-121) for the treatment of patients with Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome, at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025.

Benzinga

US Senator Claims Eating Radioactive Shrimp Will Make You An Alien - Is Video Real Or AI? The Answer Will Surprise You

Senator John Kennedy claims radioactive shrimp could turn people into aliens, sparking viral debate while experts confirm risks are real but not sci-fi extreme.

International Business Times UK

Why did a republican take a giant photo of the alien from ‘Alien’ to the Senate?

IN FULL

The Independent UK

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Republican senator suggests eating radioactive shrimp will turn you into an alien

Louisiana Republican John Kennedy claimed that eating recalled radioactive shrimp could make people resemble the creature from the sci-fi horror movie Alien – or even grow an extra ear

The Independent UK

Syndax Gains Attention With Strong Drug Portfolio, Path To Leukemia Market Growth

Investors are increasingly looking to biotechnology companies for potential breakthroughs and profitable returns, as the sector shows resilience and growth amid broader market volatility. Within this landscape, Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) is capturing attention with its promising drug portfolio and financial performance.

Benzinga

RFK Jr accused of ‘reckless disregard for science and the truth’ in Senate hearing

Health secretary defends his leadership as Democrats attack his vaccine policy and demand his resignation

The Guardian - US

FDA Outlines Process To Speed Up Rare Disease Therapy Approvals

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations.

Benzinga

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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

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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Benzinga

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.

The Independent UK

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

Reason

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.

The Texas Tribune

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.

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Benzinga

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.

Bangkok Post

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.

The Guardian - US

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

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).

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