FDA Grants Historic National Priority Vouchers to Nine Sponsors Under New Pilot Program
The U.S. Food and Drug Administration (FDA) has announced a significant development in regulatory initiatives. On October 18, 2025, the…
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FDA Warns of Serious Risks Linked to Radiofrequency Microneedling Devices for Aesthetic Skin Procedures
The U.S. Food and Drug Administration (FDA) has issued a safety communication concerning serious complications associated with the use of…
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FDA Issues Boxed Warning Update for CARVYKTI Over Rare Enterocolitis Risk
The U.S. Food and Drug Administration (FDA) has issued updated labeling for Ciltacabtagene Autoleucel (CARVYKTI), a treatment for certain patients…
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Urgent FDA Alert: Cybersecurity Vulnerability Identified in Abiomed’s Automated Impella Controller
On October 10, 2025, the FDA issued an alert regarding a cybersecurity vulnerability affecting the Automated Impella Controller (AIC) used…
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Trividia Health Initiates Precautionary Recall of Certain TRUE METRIX Blood Glucose Meters Due to Display Issue
Trividia Health, Inc., a leading global health and wellness company, has initiated a voluntary recall of a specific lot of…
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FDA Reacts to Florida’s Ban on 7-OH Opioid Products: What You Need to Know
Meta description: The FDA addresses Florida’s new restrictions on 7-OH opioid products, discussing implications for clinical and regulatory teams. Find…
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FDA Greenlights Papzimeos: First Immunotherapy for Recurrent Respiratory Papillomatosis
On October 2, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of Papzimeos, the first immunotherapy specifically…
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FDA Emergency Authorization of Animal Drugs Tackles New World Screwworm Threat to Food Supply
The U.S. Department of Health and Human Services (HHS) announced a declaration enabling the Food and Drug Administration (FDA) to…
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FDA Introduces Daily Updates on Adverse Event Reporting for Drug Safety Insights
The U.S. Food and Drug Administration (FDA) has announced a major step forward in public health transparency by initiating daily…
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FDA Demands Safer Nicotine Pouch Packaging Amid Rising Cases of Child Exposure
The U.S. Food and Drug Administration (FDA) has issued a strong appeal to nicotine pouch manufacturers, urging them to adopt…
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FDA Introduces Groundbreaking Guidance to Streamline Rare Disease Drug Development
The U.S. Food and Drug Administration (FDA) has launched the Rare Disease Evidence Principles (RDEP) initiative, promising faster and more…
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FDA Urges Retailers to Cease Illegal Vape Sales in New Compliance Initiative
Marty Makary, M.D., M.P.H., Commissioner of the U.S. Food and Drug Administration (FDA), has announced a pivotal step in addressing…
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