FDA
60 articles on FDA, researched and written by the Shotlee Editorial Team from primary sources.
What's the Deal with Peptides? The Hyped Market Under FDA Review
An in-depth look at the FDA's review of unregulated peptide therapy, the safety concerns raised by experts, and the conflict between industry demand and clinical evidence.
8 min read
Eli Lilly's Retatrutide Shows Cardiovascular and Diabetic Benefits in Trials
Eli Lilly's investigational drug, retatrutide, has shown promising results in clinical trials, offering substantial weight loss and significant improvements in cardiovascular health and type 2 diabetes management.
7 min read
New Yorkers Are Ordering Peptides Like Takeout – And California Trim Clinic Is Behind It
New York City is experiencing a surge in peptide therapy requests via telehealth platforms. This article explores the most popular compounds, safety protocols, and how to track results effectively.
8 min read
Peptides Get Their Regulatory Close-Up at FDA Review
The FDA is convening a panel to review regulations on popular injectable peptides. Learn about safety concerns, clinical evidence gaps, and what this means for patient access to peptide therapy.
8 min read
Semaglutide Offers Kidney Protection in Type 2 Diabetes and CKD, JACC Study Confirms
New findings from a major subgroup analysis of the FLOW trial, published in the Journal of the American College of Cardiology, demonstrate that semaglutide offers significant and consistent kidney protection for adults living with type 2 diabetes and chronic kidney disease (CKD). This benefit extends to individuals regardless of their existing heart disease, heart failure, or elevated cardiovascular risk.
9 min read
Thymosin Alpha-1 for Long COVID: FDA Concerns and Future Review
Thymosin alpha-1, a peptide with immune-modulating properties, is showing promise for Long COVID symptoms. However, the FDA has raised concerns about its compounding and stability, impacting its availability in the U.S. This article delves into the science, patient experiences, and regulatory landscape surrounding this peptide.
8 min read
The Peptides Bodybuilders and Gym Bros Are Using to Recover Faster After Exercise
An in-depth analysis of the peptides bodybuilders use for recovery, including TB-500 mechanisms, safety concerns, and current FDA regulatory standing.
8 min read
MOTS-C: A Peptide for Obesity Beyond GLP-1s?
While GLP-1 agonists have dominated weight loss discussions, a new peptide called MOTS-C is emerging with its own unique potential for tackling obesity and improving metabolic health. This article delves into what MOTS-C is, how it works, and its current research status.
7 min read
Melanotan II for Sunless Tan: What Young Men Are Experiencing
Young men are turning to Melanotan II for a sunless tan, but are experiencing unexpected and potentially dangerous side effects. This article delves into what the peptide is, its history, and the serious health concerns associated with its use.
8 min read
Eli Lilly Prepares FDA Run for ‘Triple-G’ Weight Loss Drug With Phase 3 Data
Eli Lilly has announced positive Phase 3 results for retatrutide, positioning the triple-agonist drug for an FDA filing in 2027 with substantial weight loss outcomes.
7 min read
Ozempic Lowers Calorie Intake For At Least A Year, Even If Hunger Returns, Trial Finds
A new 60-week clinical trial reveals that semaglutide continues to reduce calorie consumption significantly, even when subjective hunger sensations return to baseline levels.
7 min read
Millions Losing Weight Using GLP-1s: How Do Drugs Affect Love Lives?
As millions turn to GLP-1 medications for weight loss, unexpected changes in romantic relationships and sexual desire are emerging. This article explores the psychological and physiological impacts on love lives.
6 min read
The Billion-Dollar Problem Limiting Access to Ozempic, Wegovy, and Zepbound
Despite clinical evidence highlighting the significant health benefits and cost-effectiveness of GLP-1 medications such as Ozempic, Wegovy, and Zepbound, many insurance plans continue to impose restrictions on patient access. This article delves into the financial and practical barriers, as well as the profound consequences for individuals seeking these transformative treatments.
7 min read
Oral GLP-1 Drugs May Quiet the Brain's Food Craving Circuit
New research suggests that oral GLP-1 medications, including those used for weight loss and diabetes, might work by influencing the brain's reward pathways, potentially reducing cravings for enjoyable foods and offering insights into treating substance use disorders.
8 min read
Novo Nordisk Sues Eli Lilly Over Which GLP-1 Sheds the Most Pounds
Novo Nordisk has filed a federal lawsuit against Eli Lilly, alleging deceptive advertising regarding the comparative weight loss efficacy of Zepbound and Wegovy. The dispute centers on dosage comparisons and clinical trial data interpretation.
8 min read
Eli Lilly to Seek FDA Approval for Obesity Drug Retatrutide
Eli Lilly announces plans to file for FDA approval of its triple-agonist obesity drug retatrutide in early 2027 following successful Phase 3 trial data.
8 min read
The New Drug Melting Body Fat From 38% To 22% — And The Side Effects Patients Are Ignoring
A detailed look at the case of Gary Anderton, who achieved significant weight loss using unregulated peptides, and the critical safety risks associated with this trend.
8 min read
FDA to Review 7 Popular Peptides Touted for Weight Loss, Healing and Longevity
The FDA Pharmacy Compounding Advisory Committee is set to evaluate seven peptide substances currently available through the gray market. Experts weigh in on safety, efficacy, and future patient access.
7 min read
Peptides: Lab Finds Issues in 30% of Vials as FDA Panel Considers Looser Rules
Peptides are rapidly gaining traction for various health and wellness claims, but a recent lab analysis revealed significant quality control issues in a substantial percentage of tested vials. As the FDA panel prepares to discuss potentially easing restrictions, understanding the risks and the science behind these compounds is crucial.
7 min read
Compounded Ozempic and Zepbound Still Widely Available After Shortages End
Despite the FDA declaring an end to drug shortages for popular weight loss medications, a new study finds compounded versions remain easily accessible. Understanding the safety implications and regulatory landscape is crucial for patient health.
8 min read
FDA Advisory Committee Votes to Lift Restrictions on Popular Wellness Peptide BPC-157
The FDA advisory committee recently voted to recommend lifting restrictions on BPC-157. This article details the vote, the science behind the peptide, and what it means for patient access.
7 min read
Semaglutide Telehealth: From The Access Boom To Regulatory Reckoning
The rapid rise of GLP-1 receptor agonists like semaglutide and tirzepatide has transformed obesity and diabetes care, generating billions in revenue for major manufacturers while creating unprecedented demand for weight management solutions. Telehealth platforms initially emerged as a critical access channel, offering convenient prescriptions and more affordable compounded versions during national shortages. Yet by 2025 and 2026, the sector faced a sharp pivot as FDA actions resolved shortages and curtailed large-scale compounding operations.
7 min read
Novo Nordisk Sues Eli Lilly Over GLP-1 Advertising Claims in Legal Battle
Novo Nordisk has filed a lawsuit against Eli Lilly in the U.S. District Court for the District of New Jersey, alleging false advertising regarding GLP-1 weight loss medications.
7 min read
US Regulators Consider Controversial Peptides Backed by RFK Jr.
The US Food and Drug Administration is evaluating the use of seven peptides, increasingly marketed for wellness and medical conditions. This review comes amidst soaring popularity, celebrity endorsements, and significant debate over their safety and efficacy.
8 min read
Ozempic Maker Novo Nordisk Sues Eli Lilly Over 'Materially Misleading' Ads
Novo Nordisk has filed a lawsuit against Eli Lilly, alleging deceptive advertising regarding weight-loss drugs. This legal battle highlights the intense competition between semaglutide and tirzepatide.
9 min read
Jim Cramer on Eli Lilly Amid Rival's GLP-1 Lawsuit
Jim Cramer weighs in on Eli Lilly's position in the GLP-1 market following a lawsuit from competitor Novo Nordisk, analyzing the situation for investors.
7 min read
Peptide Hype: Do They Live Up to the Claims for Skin and Wellness?
From skincare routines to GLP-1 weight loss medications, peptides are everywhere. But do they deliver on their promises for skin health, longevity, and recovery? This article delves into the science and the trend.
9 min read
Dr. Reddy's Generic Ozempic Supplies Delayed on API Issue
Dr. Reddy's Laboratories has paused commercial production of generic semaglutide following quality concerns with the active ingredient. Here is what patients need to know about the delay and what it means for access to GLP-1 therapy.
8 min read
Yes, GLP-1s Make You Thinner. But Do They Make You Freer?
While GLP-1 drugs like Ozempic and Wegovy offer significant medical benefits, their rise raises critical questions about freedom, body image, and the cultural pressure to be thinner.
8 min read
Ozempic and Wegovy Use Linked to Thousands of Poison Control Calls
The widespread adoption of Ozempic and Wegovy for weight loss has coincided with a significant rise in calls to poison control centers. This article delves into the research behind this trend, highlighting common mistakes and the importance of proper patient education.
6 min read
Mounjaro's Impact on Food Cravings: A Case Study
A groundbreaking case study involving deep brain activity recordings has shed light on how tirzepatide, known as Mounjaro and Zepbound, impacts the brain's reward center and its connection to food cravings and loss of control eating.
8 min read
Novo Nordisk's Semaglutide Implant Could Replace Ozempic Injections
Novo Nordisk and Vivani Medical are developing a semaglutide implant that could eliminate the need for weekly injections. Here is everything to know about the technology.
6 min read
Eli Lilly's Foundayo: A New Daily Pill Outperforming Oral Semaglutide
A groundbreaking Phase 3 trial reveals that Eli Lilly's new daily oral medication, orforglipron (Foundayo), demonstrates superior efficacy in lowering blood sugar and promoting weight loss compared to existing oral semaglutide treatments for individuals with Type 2 diabetes. This development marks a significant step forward in non-injectable peptide therapies for metabolic health.
6 min read
Wegovy and the Wedding Dress: The Hidden Costs of Rapid Weight Loss
Prescription weight loss drugs are becoming a wedding staple, but medical experts warn of serious side effects and ethical concerns behind the trend.
9 min read
Ozempic & Wegovy Safety: The Yale Study on Online Prescribing
A recent JAMA study reveals significant gaps in medical oversight for online GLP-1 prescriptions. Discover the risks and how to ensure safe access to weight loss medications.
7 min read
Ozempic, Mounjaro & More: Yale Study Exposes Risky Online GLP-1 Prescribing
New research from Yale University highlights critical gaps in the online prescribing of GLP-1 medications, raising serious concerns about patient safety and regulatory oversight.
8 min read
Ozempic & Wegovy Online: The Risky Rush to Bypass Doctor Consultations
The surge in GLP-1 medications for weight loss has led to a concerning trend: many online pharmacies are prescribing these powerful drugs with minimal to no doctor consultation, putting patients at significant risk.
6 min read
Beyond the Hype: Understanding Peptides for Weight Loss and Health
Curious about peptides and their role in weight loss, cholesterol management, and overall health? This article breaks down what peptides are, how they work, and what the science says about popular options like GLP-1 agonists.
7 min read
Beyond the Hype: Understanding GLP-1s and Weight Management
The rise of GLP-1 medications has revolutionized weight management. This comprehensive guide delves into semaglutide, tirzepatide, and other peptide therapies, offering insights into their efficacy, potential side effects, and how to track your progress effectively.
7 min read
Medicare's $50 GLP-1 Weight Loss Drug Trial: Who Qualifies?
For many older Americans, the high cost of GLP-1 weight loss medications has been a significant barrier. Now, a new Medicare trial offers a lifeline, potentially making these life-changing drugs accessible for just $50 a month. This article breaks down what you need to know about the Medicare GLP-1 Bridge program, including who qualifies, which medications are covered, and the program's future.
8 min read
Peptides: Fad or Future? Unpacking the Hype for Skin, Weight Loss & More
From celebrity endorsements to GLP-1 weight loss drugs, peptides are everywhere. But what exactly are they, and can they deliver on their promises for skin health, longevity, and more? This article dives into the science, the trends, and the risks.
7 min read
Peptides and Health: The Truth Behind the Beauty and Weight Loss Claims
Peptides are the newest buzzword in health and beauty, promising everything from wrinkle reduction to profound weight loss. But does the science actually back up the claims, and are they safe?
7 min read
Navigating Medicare's New Path for GLP-1 Weight Loss Coverage
For years, Medicare coverage for GLP-1 medications like Ozempic and Wegovy was strictly limited to diabetes management. A significant shift is underway, however, as a new 'Bridge' program opens doors for weight loss coverage, albeit with specific requirements and nuances that patients must navigate.
6 min read
Medicare's GLP-1 Weight Loss Drug Bridge: What You Need to Know
For the first time, Medicare is expanding access to GLP-1 medications for weight loss through a new pilot program. Starting July 1, eligible beneficiaries can access popular drugs like Wegovy and Zepbound for a $50 monthly copay. This groundbreaking initiative aims to make these life-changing treatments more accessible, but understanding the specifics is crucial.
7 min read
Beyond GLP-1s: Understanding the Peptide Therapy Health Craze
Peptide therapy is rapidly gaining traction far beyond the well-known GLP-1 medications. This deep dive explores the science, the 'health-maxing' movement, supply chain complexities, and the crucial regulatory landscape shaping the future of these powerful compounds.
7 min read
Wegovy Arrives in Jordan: A New Era for Weight Management
Novo Nordisk has officially launched Wegovy®️ (semaglutide 2.4 mg) in Jordan, marking a significant advancement in the country's approach to tackling the growing challenge of excess weight and its associated health risks.
7 min read
Wegovy & Mounjaro: Navigating Medicare's New Path to Weight Loss
For years, Medicare's stance on GLP-1 medications for weight loss was a firm 'no.' However, a significant shift is underway. Discover how the new 'Bridge' program opens doors to crucial weight management tools like Wegovy and Mounjaro, and what you need to know.
6 min read
GLP-1s and Menopause: Expert Warns of Accelerated Bone Loss Risk
The collision of rapid weight loss driven by GLP-1 medications like Wegovy and Mounjaro with the natural bone density decline of menopause creates a significant, under-discussed risk for women's skeletal health.
6 min read
Ozempic Culture: Why Medical Weight Loss Needs Better Guardrails
As semaglutide medications become ubiquitous, we must balance their life-saving cardiovascular benefits with the dangers of normalizing extreme thinness and disordered eating behaviors.
7 min read
Wegovy for Children: Safety Concerns, Obesity Trends, and Expert Advice
An in-depth look at the controversial use of GLP-1 medications in pediatric patients, childhood obesity statistics, and long-term safety concerns highlighted by medical experts.
8 min read
Beyond Ozempic: Exploring the Expanding World of Peptide Therapeutics
Peptides are making waves in health and wellness, driven by the success of medications like Ozempic. This article delves into what peptides are, their growing applications, and the exciting future of peptide therapy.
8 min read
Ozempic and Testosterone: Does Weight Loss Drive Sperm Quality Gains?
A comprehensive review of clinical trials suggests that GLP-1 medications may offer reproductive benefits for men with obesity-related low testosterone, potentially surpassing traditional hormone replacement therapies.
7 min read
Semaglutide and Male Fertility: New Study Reveals Testosterone Boost
Can GLP-1 medications like Ozempic or Wegovy improve male fertility? A new study indicates potential benefits for testosterone and sperm health, but what does this mean for patients?
7 min read
Beyond the Hype: Navigating the Rise of Online Peptides
A surge in injectable peptides marketed online for enhancement purposes is outpacing regulatory oversight, creating a 'grey zone' with potential public health implications. This article delves into the complexities, risks, and what consumers should understand.
6 min read
GLP-1s & Telehealth: Navigating Risks and Ensuring Safety
The booming popularity of GLP-1 medications for weight loss has coincided with a dramatic rise in telehealth services. This article delves into the benefits and significant risks of obtaining these powerful drugs online, highlighting critical safety concerns and offering guidance for patients.
6 min read
Alli Weight Loss Pill: FDA Flags Serious Kidney Risks
The Food and Drug Administration (FDA) has issued a new warning regarding potential serious kidney complications associated with Alli, the sole over-the-counter weight loss medication available in the United States. The drug's label has been updated to reflect these risks, urging caution for consumers.
8 min read
Beyond Weight Loss: How GLP-1s Impact Your Blood Pressure
GLP-1 receptor agonists, known for their role in diabetes and weight management, are increasingly recognized for their broader health benefits, including effects on blood pressure. This article delves into how these medications work, their impact on cardiovascular health, and whether they are safe for individuals with hypertension.
8 min read
Wegovy, Ozempic & Mounjaro: The Real Truth About Weight Loss Meds
A comprehensive guide to GLP-1 receptor agonists, understanding efficacy, managing side effects, and navigating the future of obesity treatment.
7 min read
Alli's Kidney Risk: FDA Updates Label for Over-the-Counter Weight Loss Pill
The FDA has issued a critical update to the drug facts label for Alli, the only over-the-counter weight loss medication available in the U.S. The changes highlight rare but potentially severe kidney-related side effects, prompting new warnings for consumers.
7 min read
CagriSema Breakthrough: New Dual Therapy Delivers Major Weight Loss in Diabetes Trials
Explore the groundbreaking REIMAGINE trial results for CagriSema, a novel dual-agonist therapy showing superior glycemic control and weight loss in type 2 diabetes patients.
7 min read