Latest posts tagged with #FDA on Bluesky
【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 www.nbcnews.com/health/healt...
#measels #publichealth #vaccines #CDC #FDA #HHS
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
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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-...
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
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 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
(#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 #FDA #uniQure #AMT-130
Hawley introduces bill to remove #FDA approval for #Mifepristone #LAFirstNews www.louisianafirstnews.com/news/hill-po...
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 www.theguardian.com/us-news/2026...
#vaccines #CDC #FDA #HHS #science #publichealth
#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...
FDA RECALL
Brand: Primal Herbs
Product: Dietary supplement
Issue: Product contains sildenafil
Date: 03/11/2026
More: www.fda.gov/safety/recalls-market-wi... #FDA #recall
New Study Shows Drop in Tylenol Use During Pregnancy After Autism Concerns www.growingyourbaby.com/new-study-sh... #pregnancy #tylenol #FDA #CDC #research
👋 The #FDA is facing a new period of transition as Vinay Prasad, the agency’s chief medical and scientific officer, prepares to depart for the second time. This move follows a turbulent tenure marked by recurring public disputes with pharmaceutical companies.
www.theguardian.com/us-news/2026...
Had a few articles published on KevinMD about RFK wanting to deregulate peptides as well as my approach to framing personal health with my patients! Please take a look! #longevity #healthspan #peptides #kevinmd #healthcare #fda
kevinmd.com/post-author/...
