2025 has seen significant upheaval for the FDA, which means serious change for the food manufacturing industry as well. Budget cuts and substantial workforce reductions are likely to lead to casualties in communication capabilities and directly impact inspections and oversight. It’s essential to prepare accordingly to maintain a strong food safety culture throughout your operations.| AIB International Blog
The FDA can address longstanding uncertainty around ingredients like NAC by harmonizing statutory provisions instead of taking shortcuts.| Nutraceuticals World
For decades, the FDA has blacked out the names of generic drugs on inspection reports for foreign factories that were found to have safety and quality violations.|
PORT-77, an oral small molecule therapy being developed to treat erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), by Gondolabio through its affiliate Portal Therapeutics, has been granted both orphan drug […] The post PORT-77 gets FDA orphan drug, fast track designations for EPP and XLP appeared first on Porphyria News.| Porphyria News – The Web's Daily Resource for Porphyria News
The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the risk of serious kidney injury that can result from dehydration. This comes after people taking the medication for either obesity or diabetes have needed to undergo…| New Atlas
Recommendations surrounding covid vaccinations and other such shots have been confusing. Ultimately, though, little has changed. Here’s what you need to know.| Articles Archive - KFF Health News
The winners include a gene therapy for a rare form of deafness, a drug for vaping addiction, and a generic antibiotic.| STAT
Can Trump take credit for North Carolina's booming biopharma industry? Which drugs could get a shortcut to the market? All that and more on this week's episode of "The Readout…| STAT
In September, the U.S. Food and Drug Administration (FDA) announced that it has launched a pilot program aimed at streamlining the agency’s review of certain premarket tobacco product applications (PMTAs) for modern oral nicotine pouches. The announcement notes that evidence suggests nicotine pouches can help adults switch away from more harmful tobacco products. Although nicotine... Continue Reading| Tobacco Law Blog
An Ohio appellate court recently affirmed the dismissal of a case brought by the Ohio attorney general (AG) against Central Tobacco & Stuff Inc.| Tobacco Law Blog
The treatment drug to address insatiable hunger in people with Prader-Willi syndrome was greenlit this year. Discover five therapies in line for approval. The post Prader Willi syndrome: five much-anticipated therapies poised for approval appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, pr...| Labiotech.eu
Defining and Delineating Ultra-Processed Foods These comments are submitted on behalf of the Heartland Health Research Alliance (HHRA), a non-profit organization conducting research on the impacts of farming systems on the environment and public health (hh-ra.org), and the Swette Center for Sustainable Food Systems at Arizona State University. HHRA and the Swette Center submitted comments| HH-RA.org - Defining and Delineating Ultra-Processed Foods These comments a...
Preliminary meetings are occurring amid the ongoing government shutdown, while some advocates call for Health Secretary Kennedy’s removal The post It’s been a month. And we still don’t know much about Kennedy’s Long COVID consortium. first appeared on The Sick Times.| The Sick Times
There is no scientific basis or justification for vaccination (link). I support Senator Rand Paul’s position on this matter and offer a scientific argument for| BIOANALYTICX
In recent online discussions, several readers raised thoughtful questions about what defines a scientist and what truly qualifies as science. The conversation touched on topics| BIOANALYTICX
There has been much talk about a recently “discovered” study that claims to compare vaccinated and unvaccinated children, as summarized here (the article). The original| BIOANALYTICX
When asked, “What recent scientific discovery has fascinated you?“ my thoughts turn to the curious case of ivermectin and cancer — two seemingly unrelated entities now being linked in medical discussions (link).| BIOANALYTICX
EG110A received FDA fast track designation to treat neurogenic detrusor overactivity, a bladder issue common in MS.| Multiple Sclerosis News Today
An Ohio appellate court recently affirmed the dismissal of a case brought by the Ohio attorney general (AG) against Central Tobacco & Stuff Inc. (Central Tobacco), an e-cigarette retailer, in which the AG alleged that Central Tobacco sold e-cigarettes lacking FDA premarket authorization and violated the state’s Consumer Sales Practices Act (CSPA) by failing to... Continue Reading| Regulatory Oversight
Fragile X Research Q&A with Dr. Berry-Kravis on RECONNECT results, placebo effects, outcome measures, methylation, and research directions for families. The post Fragile X Research Q&A: Dr. Berry-Kravis on the RECONNECT Trial appeared first on FRAXA Research Foundation - Finding a Cure for Fragile X Syndrome.| FRAXA Research Foundation – Finding a Cure for Fragile X Syndrome
Dr. Jeannie Lee wins $1M Blavatnik Award to advance FMR1 gene reactivation therapy for Fragile X, building on years of FRAXA-funded research. The post Harvard’s Dr. Jeannie Lee Wins $1M Award to Develop Gene Reactivation Therapy for Fragile X appeared first on FRAXA Research Foundation - Finding a Cure for Fragile X Syndrome.| FRAXA Research Foundation – Finding a Cure for Fragile X Syndrome
Scholars argue that regulators and celebrities must work to halt ads for miracle weight loss products. The post Lights, Camera, Deception first appeared on The Regulatory Review.| The Regulatory Review
As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects. A| Drug & Device Law
Jyotsna Shah, PhDDr. Jyotsna Shah is an immunologist and molecular biologist with over 40 years of experience in diagnostic tools for tick-borne diseases. She holds a Ph.D. in diagnostic immunology from the University of Nairobi and conducted postdoctoral work at Harvard University. Shah joined IGeneX in 1997, becoming Laboratory Director in 2003 and now serving...| Bay Area Lyme Foundation
Bryan Haynes, head of Troutman Pepper Locke’s Tobacco + Nicotine practice, was quoted in the September 24, 2025 Bloomberg Law article, “Tobacco Industry Fights Biden’s Proposed Cigarette Nicotine Cut.” “Technical achievability is something that FDA is required by law to consider when it implements a tobacco product standard, and it’s not clear to me that... Continue Reading| Tobacco Law Blog
The US has officially got a homegrown hero in the burgeoning global industry of effective weight-loss treatments, with the FDA approval of Eli Lilly’s Zepbound. The company has announced the once-a-week injectable drug's cost, dosages, insurance subsidies and when it will be on shelves.| New Atlas
The stock market—and biotech insiders—reacted negatively to the allegedly forced resignation of CBER Director Peter Marks, who said RFK Jr. does not seek “truth and transparency” but rather “subservient confirmation of his misinformation and lies.”| BioSpace
While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers who have recently left the agency is unprecedented. The lack of communication, transparency and human decency is as well.| BioSpace
The FDA derives just under half of its yearly funding from pharma user fees, which help support its operations and fund employee salaries. An analysis from AgencyIQ suggests that the agency is dangerously close to losing it all.| BioSpace
It is essential to note that the term “study,” as used here (quote) and throughout much of the medical literature, most often refers to an observational survey rather than a valid scientific study. The same applies to the term “research” in medicine—what is called “medical research” is frequently nothing more than a survey, sometimes with statistical analysis added, but still not scientific research in the true sense.| BIOANALYTICX
In our latest article (1) we introduced the new head of the Federal Drug Administration, Marty Makary. That article dealt with the ending of the exorbitant pricing of many drugs. This current articles focuses on the introduction of a huge nationwide study that will go into the possible effects of the mRNA vaccines. In the […]| Gondolath – Deep State Study Group
One of the major players within the globalistic power structures must be the pharmaceutical companies, often referred to as ‘Big Pharma’ by their critics. So when Trump promised to drain the swamp, it would be logical to take on these pharmaceutical giants. On May 12, 2025 Trump announced an executive order that would basically force […]| Gondolath – Deep State Study Group
The FDA has authorized two versions of SOMNOmedics’ forehead-applied type II home sleep test with a pulse oximeter ring. Use cases range from insomnia screening to CPAP efficacy monitoring.| Sleep Review
The device, cleared for mild to moderate OSA, is available immediately. PDAC coverage is pending.| Sleep Review
About 93 reworked units distributed in the United States and France may have incorrect configurations that could lead to serious health risks.| Sleep Review
On September 22, the United States Department of Health and Human Services, under Health Secretary Robert F. Kennedy (RFK) Jr., released a report that falsely associates the intake of acetaminophen (more commonly and commercially called Tylenol), by pregnant women, with autism in their offspring. The Food and Drug Administration updated…| TrumpFile.org
The post FOIA Requesters Probe Trump Administration AI Moves appeared first on Poliscio Analytics LLC.| Poliscio Analytics LLC
Trump made his claims during a White House briefing on Monday. Kenvue, the company that makes Tylenol, denounced Trump's claims as nonfactual.| NewsOne
First published by GR on August 5, 2020 Polymerase Chain Reaction (RT-PCR) tests are used worldwide to “diagnose” Sars-Cov-2 infection. An in-depth investigation reveals clear scientific evidence proving that these tests are not accurate and create a statistically significant percentage of false positives. Positive results more likely indicate “ordinary respiratory diseases like the common cold.” …| Global Research
In May, we wrote about the Trump administration’s first major enforcement action involving the importation of unauthorized e-cigarettes, in which the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) seized products valued at nearly $34 million. FDA and CBP have once again seized unauthorized e-cigarettes in Chicago, but this time... Continue Reading| Tobacco Law Blog
As the release of a CRL declining Lykos' therapy generates a strong reaction from MAPS, delve into what this new transparency could change.| Labiotech.eu
The EU banned TPO-based gel nail polish in 2025 over safety concerns—learn why it's banned in Europe but still allowed in the United States.| The ANSI Blog
“The greatest spreader of misinformation during the pandemic was the United States government.”“And that is the weaponization of medical research itself.”“And public-health officials were intellectually| BIOANALYTICX
Thank you for sharing your thoughts. In general, I agree with your comment and conclusion—except for the last sentence: “A formal education in a topic doesn’t guarantee you are right.” (link)| BIOANALYTICX
Medical experts, in particular physicians, are, in fact, the least knowledgeable in real science. They have zero scientific credentials, yet they lie about having them. This is the critical point: rather than demanding records on vaccines or viruses, authorities must first demand that they prove their claim that their work is based on science and that they have the required education and expertise in science. They cannot—because they have no credentials. At that moment, the game is over. No...| BIOANALYTICX
In May, we wrote about the Trump administration's first major enforcement action involving the importation of unauthorized e-cigarettes, in which the U.S.| Regulatory Oversight
The HST maker will immediately begin commercialization of the device, leveraging its dedicated US salesforce.| Sleep Review
Fragile X syndrome research explores insulin and cAMP pathway crosstalk, mapping brain metabolism to guide treatment strategies. The post Metabolic and Mitochondrial Crosstalk in Insulin and cAMP Pathways in Fragile X Syndrome appeared first on FRAXA Research Foundation - Finding a Cure for Fragile X Syndrome.| FRAXA Research Foundation – Finding a Cure for Fragile X Syndrome
Discover dicentra’s integrated framework for validating point-of-care (POC) diagnostics, from lab to clinic to regulatory approval.| dicentra
Discover why prevention is the smartest investment in pet product safety and how quality systems, training, and third-party verification reduce recall risks.| NASC LIVE
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump administration could move forward with its sweeping reorganization of the agency.| BioSpace
You’ve probably heard by now about the massive Mid America Pet Food recall; if you haven’t, here’s what’s going on: Late Thursday evening, the U.S. Food and Drug Administration (FDA) (…) Read more| Poisoned Pets | Pet Food Safety News
Recently the US Food and Drug Administration approved Sanofi's new quadrivalent meningococcal vaccine, MenQuadfi, for injection into infants between the ages of six weeks and 23 months. MenQuadfi was first...| Health Freedom Defense Fund
This article was originally published on August 29, 2025 on Law360 and is republished here with permission. On June 20, in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., the U.S. Supreme Court concluded that marketing denial orders issued by the FDA regarding new tobacco products can be challenged not only by the... Continue Reading| Tobacco Law Blog
On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its June 2022 marketing denial order (MDO) for certain flavored, disposable electronic nicotine delivery systems (ENDS). As we recently covered... Continue Reading| Tobacco Law Blog
While some skin lightening products may be effective, they can come with risks that are often hidden and can be life-threatening. Read more.| LegitScript
Heart devices lead medtech’s summer financing surge. This and more in this week’s life sciences update.| The Real Economy Blog
On first glance, Dr. Vinay Prasad’s medical credentials sound impressive. But look closer and you’ll find a narcissistic attention-seeker peddling misinformation, whose views will cost lives.| The New Republic
Hindsight is 20/20. What happened in 2020? The COVID-19 experiment happened! Nowadays, no one is talking about The Experiment unless it is to complain about "misinformation." Forget that the COVID-19 pandemic, its rituals, and its products destabilized world economies, politics, social and food systems, and freedoms. Forget that the COVID-19 shots were "experimental," promoted as [...]| Nature of Healing
Fragile X syndrome fundraising took center stage at Patrick’s PALS 29, raising over $150,000 at Boston’s premier 3-on-3 basketball event. The post Patrick’s PALS 29 Raises Over $150K for Fragile X Syndrome at 3-on-3 Tournament appeared first on FRAXA Research Foundation - Finding a Cure for Fragile X Syndrome.| FRAXA Research Foundation – Finding a Cure for Fragile X Syndrome
FDA has banned Red 3 for foods & ingestible drugs. Learn the impact, compliance dates, and petition steps for ingredient companies.| dicentra
FDA 510(K) clearance received for first medical product based on our novel Flat Panel Source. We aim to transform medical radiology with affordable low-dose Point-of-Care 3D imaging to replace 2D X-ray; for quicker, more accurate diagnosis| Adaptix
Article Revision: Updated August 24, 2025This article has been revised to clarify that the modern hemp industry began in the 1990s, honoring the pioneers, advocates, and entrepreneurs of that era who laid the foundation for the industry’s return to U.S. soil in 2014. The original version of this article suggested Hemp 1.0 began only with […] The post Hemp 3.0: The Next Chapter of the American Hemp Industry first appeared on Let's Talk Hemp.| Let's Talk Hemp
Friends of NoCo Hemp Expo, thank you. After more than a decade of rolling up sleeves and raising roofs, I can say with a grin, what a long, strange trip it’s been. We built something together that mattered. And we are not done. I am resetting, refining, refocusing, and pressing onward. Fall down seven times, […]| Let's Talk Hemp | #1 Website for Cannabis and Hemp News, Hemp Events
In July to August 2025, the Charlotte Lozier Institute (CLI) submitted three comments regarding three citizen petitions submitted to the Food and Drug Administration requesting regulatory action on the abortion drug mifepristone. Below, brief summaries and links for each of these comments are provided. CLI Comment on Massachusetts AG et al. Citizen Petition (Submitted 7/24). […]| Lozier Institute
The post Some Research Into Short-Seller Culper Research appeared first on Poliscio Analytics LLC.| Poliscio Analytics LLC
The post ExodusPoint Gains A Unique Advantage appeared first on Poliscio Analytics LLC.| Poliscio Analytics LLC
The Republican attorneys general call on the FDA to bring back regulations ‘it identified as necessary as recently as 2011’ but were removed under Obama and Biden or pull abortion pills from the market.| LifeSite
The U.S. FDA has granted orphan drug designation to CS1, Cereno Scientific’s lead therapy candidate for treating pulmonary arterial hypertension (PAH).| Pulmonary Hypertension News
Novo Nordisk’s GLP-1 drug Wegovy expanded its label to include the metabolic disorder known as MASH. Analysts say there’s room for many MASH drugs with the treatment landscape expected to shape up to include combinations of therapies bringing different approaches to this fatty liver disease.| MedCity News
In early August, the U.S. District Court for the Northern District of Texas ruled that the civil money penalty (CMP) provision in the Food, Drug, and| Tobacco Law Blog
Each week we highlight five things affecting the life sciences industry. Here’s the latest.| The Real Economy Blog
President Trump imposes reciprocal tariffs on over 60 countries, FDA launches PreCheck Program to streamline regulatory review, and more…| The Regulatory Review
The announcement by the Department of Health and Human Services highlighted a flurry of moves, which include the shifting of departments. Also this week, HHS Secretary Robert F. Kennedy Jr. tapped fellow vaccine critic David Geier to investigate vaccine safety within the CDC.| BioSpace
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.| BioSpace
From the rice paddies of Thailand to the sun-scorched plains of the American Midwest, from the green hills of Europe to the vibrant markets of South America, a quiet movement has been growing. A global cadre of visionaries has spent the last decade moving through time zones and cultures with one common thread guiding them: […] The post From Fields to Futures: Hemp’s Global Mission first appeared on Let's Talk Hemp.| Let's Talk Hemp
The first FDA-approved eye drops to treat age-related blurry near vision (presbyopia) has gone on sale in the US, offering a potential alternative to reading glasses for the estimated 128 million Americans affected by this common condition.| New Atlas
The first aceclidine-based eye drop to improve near vision in adults with presbyopia, which affects more than 100 million adults in the US alone, has been approved by the Food and Drug Administration (FDA) and will be available within three months.| New Atlas
The US Food and Drug Administration’s controversial recent approval of Alzheimer’s drug Aduhelm has been subject to vociferous criticism from many in the scientific community. Amidst concerns surrounding the drug’s efficacy and price, several expert advisors to the FDA have resigned in protest and…| New Atlas
A new Alzheimer’s disease treatment has been controversially approved for use in the United States despite an independent Food and Drug Administration (FDA) advisory panel reporting last year the drug’s Phase 3 trial results were inconclusive. The approval marks the first new treatment for…| New Atlas
Dr. Vinay Prasad, a progressive activist, is undermining Trump’s FDA and the Make America Healthy Again agenda from within.| Loomered
New narcolepsy treatments are being tested in the clinic, and recently, some of them have made promising strides. How far along are they?| Labiotech.eu
As Congress considers amendments that could once again stifle the U.S. hemp industry, including the deeply flawed Miller Amendment language, it’s time to reassess how we regulate this transformative crop. Hemp, in all its forms, deserves rational, science-based regulation. What it doesn’t need is more prohibition. Because prohibition doesn’t work. It never has. Prohibition Sets […]| Let's Talk Hemp | #1 Website for Cannabis and Hemp News, Hemp Events
By Brian Bienkowski The US Food and Drug Administration (FDA) approved another naturally derived food dye on Monday, making good on one of its key promises in the effort to rid the US food system of petroleum-based synthetic dyes.| The New Lede
The ASAM Joint Clinical Practice Guideline on Benzodiazepine Tapering is now available. Some of us at BIC, including the late Dr. Christy Huff, served voluntarily on the Patients with Lived Experience (PWLE) panel (see our names on page...| Benzodiazepine Information Coalition
FDA tools Elsa and CDRH-GPT mark a shift in oversight. Learn how AI could impact GRAS, NDI, and device reviews and how to be submission-ready| dicentra
Amgen announced May 2nd financial results for the first quarter 2024, and its shares soared right after the announcement, which was followed closely by a FDA approval of a lung-cancer drug. “With many of our innovative products delivering strong growth and promising new medicines advancing through our pipeline, we are excited about delivering attractive long-term […] The post Amgen Shares Value Rose After Financial Results And New Drug Related Announcement appeared first on Healthcare Wee...| Healthcare Weekly
From Med City News. "A Bristol Myers Squibb drug whose landmark FDA approval introduced the first novel mechanism for treating schizophrenia in decades| Mad In America
The biopharma job market likely won’t turn around until 2026, according to two industry experts. Both cited a need for more investment and noted the impact of uncertainty on the industry.| BioSpace
Press Conference prior to the 2006 FDA Advisory Committee Public Hearing on the connection between antidepressants and suicidal thoughts and actions. The press conference was put together by the family of Woody Witczak. Vera Sharav: Watch on Youtube Kim Witczak: Watch on youtube Dr. Joseph Glenmullen discussed a side effect...| Message to Germany | Alliance for Human Research Protection
By Brian Bienkowski Chemicals used to make plastics more flexible are linked to more than 356,000 deaths annually across the globe, creating what researchers called a “substantial global health burden,” according to a new peer-reviewed study.| The New Lede
By Brian Bienkowski Federal health officials announced plans Tuesday to phase out synthetic food dyes made from petroleum, marking a significant shift in how the U.S. regulates chemical additives in food.| The New Lede
DUBLIN, IRELAND and OXFORD, UK, April 14, 2025 – SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing of … Continue reading "SynOx Therapeutics Receives Fast Track Designation from U.S. Food and Drug Administration for Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT)"| Synox | Website
By: Cullen Irwin With the advent of a new administration and the overturning of Chevron comes deregulation initiatives across several industries, creating a slew of implications for drug regulation under the watch of the newly minted Secretary of the Department of Health and Human Services, Robert Kennedy, Jr. (RFK Jr.). RFK Jr.’s confirmation resulted in significant […]| Wake Forest Law Review
As the Food and Drug Administration (FDA) sets global standards in many ways, any disruptions in its operations could create a ripple effect in other regulatory agencies around the world, including the European Medicines Agency (EMA).| FleishmanHillard
Merchants are facing increasing scrutiny for selling nutraceuticals tainted with harmful ingredients. Learn how to avoid this kind of merchant risk.| LegitScript
Among alternative products is kava — an elixir that’s been gaining traction around the world. But its legality is complicated. Read more.| LegitScript
by Gertrud U. Rey The number of measles cases is steadily increasing across the United States, especially in areas with low vaccination rates. Instead of recommending that children be vaccinated with the measles, mumps, and rubella (MMR) vaccine, US Health and Human Services Secretary Robert F. Kennedy Jr. continues to promote ideas that are rooted …Vitamin A, Cod Liver Oil, and Measles Read More »| Virology Blog
Is eliminating self-affirmed GRAS the answer? Kennedy thinks so—dicentra explores what this means for FDA oversight and food safety.| dicentra
Es brauchte Trumps Wahl, damit die wirren Ansichten von RFK Jr. auch bei stärker bekannt wurden. Früher war er mit seiner Medizinesoterik bei Grünen und Linken hierzulande ein gern gesehener Gast – und bis heute bleibt man sich in vielen zentralen Fragen einig.| Salonkolumnisten
