#FDA update on #leucovorin
It was approved for a rare genetic disorder that impairs folate delivery to the brain not #autism
✔️ Best signal → language improvements
✔️ Some effect → social communication
✔️ Biggest responders → abnormal folate metabolism
Evidence > hype
#mentalhealth #ASD #medication

Unlocking a $50 Billion Market: Ispire and FDA's Guidance on Flavored ENDS Ispire Technology Inc. reveals the significant economic potential unlocked by the FDA's new guidance on flavored electronic nicotine delivery systems, opening a path to a $50 billion market.

Unlocking a $50 Billion Market: Ispire and FDA's Guidance on Flavored ENDS #United_States #Los_Angeles #FDA #Ispire_Technology #flavored_ENDS

#TheLensNola🔍 Republican lawmakers are focused on limiting the availability of abortion medication, the most common way to terminate early pregnancies in the United States.

✍ Elisha Brown

Full story: buff.ly/zUKuP7R

#abortionmedication #senjoshhawley #FDA

Ozempic Controversy Deepens as FDA Accuses Novo Nordisk of Failing to Report Patient Deaths, One Linked To Suicide Novo Nordisk faces FDA scrutiny for failing to report Ozempic-linked deaths, highlighting systemic issues in safety reporting. Learn about the implications for patient safety and ongoing legal challen...

The FDA says Novo Nordisk failed to report three patient deaths, including one suicide. And inspectors believe those aren't the only cases they missed.

#Ozempic #FDA

www.ibtimes.co.uk/novo-nordisk...

エンハーツ、HER2陽性早期乳がんの術後療法で米国FDAの優先審査に指定 再発・死亡リスクを53％低減 | STELLANEWS.LIFE STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見 | STELLANEWS.LIFE（ステラニュース・ライフ）は、科学や技術、医薬品分野における最新の研究成果や発見

【ENHERTU Granted Priority Review in the US for Patients with HER2-Positive Early Breast Cancer】
エンハーツ、HER2陽性早期乳がんの術後療法で米国FDAの優先審査に指定 再発・死亡リスクを53％低減

stellanews.life/technology/9...

#Enhertu #BreastCancer #FDA #PriorityReview #HER2Positive #MedicalNews

FDA RECALL
Brand: Boner Bear, Red Bull and Blue Bull
Product: Honey dietary supplement
Issue: Product contains sildenafil and tadalafil
Date: 03/14/2026
More […]

Regulatory presentations require precision and expertise. SlideSource provides full support for FDA AdComms and CHMP meetings, and more. #RegulatoryExperts #PharmaSupport #FDA #CHMP

https://bit.ly/3zBBsIh

Utah measles outbreak speeds up but there are few changes to daily life Health officials in the outbreak's epicenter are relying on social media and talk radio to reach residents. Many aren't listening.

Utah measles outbreak speeds up but there are few changes to daily life www.nbcnews.com/health/healt...

#measels #publichealth #vaccines #CDC #FDA #HHS

Anti-trans hate groups petitioning FDA for registry of trans women, crackdown on transition, newly revealed document shows In the short term, this is not as dangerous as an outright ban on estrogen. If implemented and then combined with other methods of suppressing trans people, it might be far more destructive in the lon...

Oh, anti-trans groups being gross, as usual: theneedlenews.com/anti-trans-h...

#Bluesky #FDA #fuckTERFs #protecttranspeople #list

FDA RECALL
Brand: Omnipod
Product: Alternate controller enabled insulin infusion pump
Issue: Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended.
Date: 03/13/2026
More […]

FDA Approves Wakix for Cataplexy in Pediatric Narcolepsy New FDA approval for Wakix (pitolisant) allows for the treatment of cataplexy in pediatric narcolepsy patients.

In honor of #WorldSleepDay, check out our story on the Food and Drug Administration’s (#FDA) recent approval of Wakix® (pitolisant) for treatment of cataplexy in pediatric patients with #narcolepsy 🔽

www.sleepwakeadvisor.com/news/fda-approves-wakix-...

Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months The FDA's cancer advisors will discuss AstraZeneca’s application for the oral SERD camizestrant in breast cancer and the AKT inhibitor Truqap in prostate cancer.

NCHR President Diana Zuckerman told reporters this panel should include more diversity of opinion than has been seen recently.

Cancer patients deserve rigorous, transparent reviews with solid evidence.

#FDA #CancerResearch #BreastCancer #ProstateCancer

www.biospace.com/fda/two-astr...

The 21st Century Cures Act creates an exception for Clinical Decision Support Software. If you're developing software that supports healthcare professionals in making decisions, you might not need FDA regulation. #CDS #FDA

Late-stage trial results show strong reductions in kidney damage markers, pushing experimental therapy closer to potential US approval.

vist.ly/4uu8q

#longevity #KidneyDisease #Biotech #DrugDevelopment #ClinicalTrials #FDA #Biopharma

llustration of a cell undergoing division, showing two nuclei forming within a translucent cell membrane

Opinion piece: The #FDA must regulate #StemCell therapies to mitigate risks to patients and the public. In PNAS Front Matter: https://ow.ly/RRoL50Yttgt

#StemCellTherapy #HHS #Evidence-basedMedicine #AdultStemCells #EmbryonicStemCells

FDA Launches New Adverse Event Look-Up Tool FDA launched a new unified platform for analyzing adverse event reports. This platform — called the FDA Adverse Event Monitoring System (AEMS) — represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.

The FDA launched a new unified platform for analyzing adverse event reports. This platform represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.
https://post.citiprogram.org/3NBKUTd
#FDA #AdverseEvents

The US #FDA approves a wearable tumor treating fields (#TTFields) device for #pancreaticcancer. In a phase 3 trial, adding it to a chemotherapy regimen improved survival and delayed pain progression, with the main side effect being mild, localized skin reactions, including inflammation, rashes, and

FDA move on flavored vapes rattles public health experts New FDA guidance suggests mint, coffee, and spice vape flavors could be authorized, raising debate over toxic additives and youth vaping risks.

FDA move on flavored vapes rattles public health experts www.statnews.com/2026/03/13/f... via @statnews.com

#FDA #CDC #HHS #publichealth #science

#FDA to Revoke Authorization for the Use of #Red No. 3 in Food and Ingested Drugs

fda.gov/food/hfp-con...
U.S. Food & Drug Administration 1/15/2025

Pills sold nationwide contain poison, FDA warns Pills sold nationwide are being recalled due to a poisonous plant found in the products.

(#DietarySupplement) Pills (By G.A. Mart dba H&Natural) sold nationwide contain #poison (yellow oleander), #FDA #warns

By Matthew Self
yahoo.com/news/pills-s...
Yahoo, KSNT Topeka 2/24/2024

FDA RECALL
Brand: Favorina
Product: Chocolate Ladybugs - German-Style Nougat Candy
Issue: Undeclared hazelnut allergen
Date: 03/12/2026
More […]

🔴 Free access now live for PIOL Radar™ at Radar.PIOL.ai
No credit card required.
Explore regulatory intelligence, FDA enforcement signals, recall trends, and risk visibility in one place.
Go in. Explore. Decide on value.
#PIOLRadar #FDA #Compliance #Quality #Regulatory #Leadership

Federal Officials Accuse uniQure of Misleading Data in AMT-130 Drug Controversy uniQure is facing serious allegations from federal health officials regarding manipulated data for its AMT-130 drug, amid a class action lawsuit.

Federal Officials Accuse uniQure of Misleading Data in AMT-130 Drug Controversy #FDA #uniQure #AMT-130

Hawley introduces bill to remove #FDA approval for #Mifepristone #LAFirstNews www.louisianafirstnews.com/news/hill-po...

Pharmalittle: We're reading about telehealth prescribers, a Lilly push against compounding, and more Medical groups affiliated with telehealth companies the FDA warned about marketing of compounded weight loss drugs may be under the microscope, too

Pharmalot.. Pharmalittle.. Good Morning: We’re reading about telehealth prescribers, a Lilly push against compounding, and more news.. statnews.com/pharmalot/20... #pharma #FDA #telehealth #obesity #GLP1 #compounding #abortion #Lilly

There have been about 15 minutes of laying down the rules, discussing conflicts and whether or not panelists are granted waivers. Such a breath of fresh air in comparison to ACIP meetings.

#IDsky #vaccines #FDA #influenza #flu #healthpolicy

🚨 Latest #FDA Update!

🔷 Cairn Surgical has submitted a De Novo 510(k) pre-market application to the FDA for its breast cancer locator system. The technology is designed to help surgeons more precisely identify tumor locations during breast cancer procedures.

Join the thousands of subscribers to our free newsletter and keep your knowledge of the latest clinical trial regulatory updates current: https://ow.ly/QEU850YreTy

#regulatoryintelligence #regulatorycompliance #regintel #medicaldevices #biotech #pharma #FDA

Experts fear ‘unethical’ vaccine trial in Africa is ‘prototype’ for US studies under RFK Jr Danish researchers whose work on effects of vaccines has been called into question are at center of US vaccine policy

Experts fear ‘unethical’ vaccine trial in Africa is ‘prototype’ for US studies under RFK Jr www.theguardian.com/us-news/2026...

#vaccines #CDC #FDA #HHS #science #publichealth

Novo rapped by FDA for not reporting drug adverse effects Novo Nordisk has been sent a warning letter from the FDA for violations of postmarketing adverse drug experience (PADE) regulations.

#NovoNordisk has been sent a #warningletter from the #FDA for a series of violations of postmarketing #adversedrugexperience (PADE) regulations, including failure to report #sideeffects among patients using its #GLP1 drugs for diabetes and weight loss.

pharmaphorum.com/news/novo-ra...