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The Latest Breaking News from FDA

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

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

Reason

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

The Guardian - US

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

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

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.

Benzinga

Two brothers have the same genetic disorder. Their insurance only covered life-altering treatment for one of them

Exclusive: Alison Joseph's sons Noah and Hunter both have Duchenne muscular dystrophy. She tells Rhian Lubin the heartbreaking reality of watching one thrive while the other suffers

The Independent UK

Maryland screwworm case has US officials bracing for return of an old foe

Rise in cases south of the border prompts concern over US livestock as Trump budget cuts hit research and foreign aid

The Guardian - US

LSD shows promise for reducing anxiety, shows drugmaker's study

The psychedelic drug LSD showed positive results for easing symptoms in people with generalised anxiety disorder, a recent study has shown.

Euronews

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Florida surgeon general Ladapo's vaccine mandates opposition goes against medical mainstream

Dr_ Joseph Ladapo, a Nigerian-born physician with impeccable U_S_ medical credentials, says that requiring vaccinations for diseases like measles, polio and chickenpox amounts to government-imposed “slavery.”

The Independent UK

6 Times a Recalled Product Was Still on the Shelf

Picture this: a product is recalled for safety, yet it somehow ends up still sitting on store shelves. It’s alarming, and potentially dangerous—and yes, it happens more often than you’d think. Learning about each recalled product on the shelf instance helps you stay alert, know what to check for, and…

Grocery Coupon Guide

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

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

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The Guardian - US

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

Benzinga

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.

The Guardian - US

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

Benzinga

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…

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news in one place.

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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.

Texas Observer

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.

The Independent UK

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

Benzinga

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.

Fortune

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.

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

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