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FDA Demands Safety Data for Lilly's Oral GLP-1 Drug Foundayo

FDA Demands Safety Data for Lilly's Oral GLP-1 Drug Foundayo

FDA Demands Safety Data for Lilly's Oral GLP-1 Drug Foundayo
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FDA Introduces New Draft Safety Guidelines to Accelerate Bespoke Gene Therapies

FDA Introduces New Draft Safety Guidelines to Accelerate Bespoke Gene Therapies

The FDA has released new draft guidance aimed at standardizing safety evaluations for genome editing therapies. This initiative is part of a broader effort to expedite the development of personalized treatments for ultra-rare diseases. The guidance, issued by the FDA’s Center for Biologics Evaluation and Research, builds on previous guidelines from 2024 and focuses on both ex vivo and in vivo products. It includes recommendations for sequencing strategies and analysis parameters to ensure comprehensive safety assessments. The FDA is seeking public comments on these guidelines, which are designed to support nonclinical studies accompanying investigational new drug and biologics license applications. This move follows the FDA's earlier announcement of a new pathway to accelerate bespoke therapies, exemplified by the creation of a custom CRISPR therapy for a child with a rare metabolic condition.
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FDA Demands Transparency from Drug Developers, Urges Public Disclosure of Trial Results

FDA Demands Transparency from Drug Developers, Urges Public Disclosure of Trial Results

The Food and Drug Administration (FDA) has issued a directive to over 2,200 drug developers, reminding them of their legal obligation to publicly disclose clinical trial results on the federal database, clinicaltrials.gov. This move is part of the FDA's broader initiative to enhance transparency within the pharmaceutical industry. According to the FDA, approximately 29.6% of mandated studies have not complied with this requirement, leading to significant gaps in the public record. The FDA emphasizes that the failure to report, particularly negative outcomes, skews the perception of drug development by overrepresenting successes. The agency is seeking voluntary compliance but warns that non-compliance could result in civil penalties or criminal prosecution. This transparency push aligns with the FDA's ongoing campaign to foster accountability and professionalism in the industry.
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FDA Considers Lifting Restrictions on Peptides Amid Wellness Trend

FDA Considers Lifting Restrictions on Peptides Amid Wellness Trend

The Food and Drug Administration (FDA) is evaluating the possibility of allowing compounding pharmacies to produce seven peptides that are currently restricted due to safety concerns. This move comes as peptides gain popularity for their purported wellness and anti-aging benefits. Health and Human Services Secretary Robert F. Kennedy Jr. has expressed support for making these peptides more accessible, citing their potential benefits for conditions such as ulcerative colitis, wound healing, and obesity. The FDA's advisory panel on pharmacy compounding is set to discuss these peptides in a meeting scheduled for late July. The agency's previous classification of certain peptides as 'Bulk Drug Substances that Raise Significant Safety Risks' has led to a black market for these substances.
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FDA Classifies Cough Drops Recall as Moderate Risk Due to Quality Concerns

FDA Classifies Cough Drops Recall as Moderate Risk Due to Quality Concerns

The U.S. Food and Drug Administration (FDA) has classified a nationwide recall of multiple cough drop products as a Class II recall, indicating a moderate risk to consumers. The recall, initiated on March 20, 2026, was prompted by an FDA inspection at an overseas manufacturing facility that revealed conditions potentially affecting product quality. The affected products, manufactured in China by Xiamen Kang Zhongyuan Biotechnology Co., Ltd., include various flavors and are distributed under several brand names such as Exchange Select and Caring Mill. These products are sold in packages ranging from 25 to 90 counts and have expiration dates in 2026. The FDA's classification suggests that while the likelihood of serious harm is low, the use of these products may cause temporary or medically reversible adverse health effects.
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FDA Urges Over 2,200 Sponsors and Researchers to Disclose Clinical Trial Results

FDA Urges Over 2,200 Sponsors and Researchers to Disclose Clinical Trial Results

The U.S. Food and Drug Administration (FDA) has issued reminders to more than 2,200 medical product companies and researchers about their obligation to submit clinical trial results to ClinicalTrials.gov. This action addresses the issue of non-disclosure of trial results, which can lead to publication bias and a skewed perception of drug efficacy and safety. According to the FDA, nearly 30% of studies that should report results have not done so, particularly those involving FDA-regulated products. The agency's reminders aim to encourage voluntary compliance before considering further regulatory actions.
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FDA Grants Priority Review to Ifinatamab Deruxtecan for Small Cell Lung Cancer Treatment

FDA Grants Priority Review to Ifinatamab Deruxtecan for Small Cell Lung Cancer Treatment

The U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for ifinatamab deruxtecan, a potential first-in-class B7-H3 directed DXd antibody drug conjugate developed by Daiichi Sankyo and Merck. This investigational drug is intended for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum-based chemotherapy. The Priority Review status indicates that the FDA sees significant potential for the drug to improve treatment outcomes compared to existing options. The application is also being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, which aim to expedite the availability of effective cancer treatments. The Prescription Drug User Fee Act (PDUFA) date for the FDA's decision is set for October 10, 2026.
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FDA Considers Easing Restrictions on Unproven Peptides Popular Among Wellness Influencers

FDA Considers Easing Restrictions on Unproven Peptides Popular Among Wellness Influencers

FDA Considers Easing Restrictions on Unproven Peptides Popular Among Wellness Influencers
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FDA Considers Easing Restrictions on Peptide Injections Amid Safety Concerns

FDA Considers Easing Restrictions on Peptide Injections Amid Safety Concerns

The Food and Drug Administration (FDA) is evaluating the possibility of allowing compounding pharmacies to produce seven peptides that are currently restricted due to safety concerns. This move comes as peptides gain popularity for their purported wellness and anti-aging benefits, despite many claims remaining untested. Health Secretary Robert F. Kennedy Jr. has expressed support for making peptides more accessible, citing the need to curb the illicit market that has emerged due to current restrictions. The FDA's advisory panel on pharmacy compounding is set to discuss the potential use of these peptides for various conditions, including ulcerative colitis and obesity, in a meeting scheduled for late July. The agency has previously categorized certain peptides as too risky for compounding, but the growing demand and unauthorized sales have prompted a reevaluation.
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FDA Urges Over 2,200 Sponsors to Disclose Clinical Trial Results, Addresses Publication Bias

FDA Urges Over 2,200 Sponsors to Disclose Clinical Trial Results, Addresses Publication Bias

The U.S. Food and Drug Administration (FDA) has reminded more than 2,200 medical product companies and researchers to submit clinical trial results to ClinicalTrials.gov. The agency highlights the issue of publication bias, where negative trial results are often not disclosed, leading to a skewed perception of drug efficacy and safety. The FDA's initiative aims to ensure transparency and improve public access to clinical data. The agency has sent messages to companies and researchers to encourage voluntary compliance with reporting requirements, emphasizing the ethical obligation to disclose all trial outcomes.
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Mail-order dominates US abortion pill dispensing

Mail-order dominates US abortion pill dispensing

By Ahmed Aboulenein WASHINGTON, April 13 (Reuters) - U.S. pharmacies are largely filling prescriptions for the abortion pill mifepristone via mail-order in states permitting telehealth access to the medication, despite a 2023 FDA decision allowing retail pharmacies to dispense the drug, according to
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Blueroot Health Expands Recall of Dietary Supplements Due to Life-Threatening Allergens

Blueroot Health Expands Recall of Dietary Supplements Due to Life-Threatening Allergens

Blueroot Health has expanded its voluntary recall of Vital Nutrients Aller-C dietary supplements after discovering undeclared allergens that pose serious health risks. The recall, initially announced in late March, now includes all products manufactured using lot 25E04. The undeclared allergens include egg, hazelnut, and soy, which could cause life-threatening reactions in sensitive individuals. The affected supplements, sold in bottles of 100 or 200 capsules, were distributed nationwide through the company's website and other online retailers. The issue was identified during routine internal testing, prompting Blueroot Health to notify the FDA and expand the recall. No illnesses have been reported so far, but consumers with allergies to the undeclared ingredients are advised to stop using the product immediately and return it for a replacement.