FDA Grants Conditional Approval for Cattle Treatment Addressing New World Screwworm and Fever Ticks
The U.S. Food and Drug Administration (FDA) has granted conditional approval for Exzolt Cattle-CA1 (fluralaner), a topical solution designed to…
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FDA Grants Approval to First CAR T-Cell Therapy for Marginal Zone Lymphoma in the U.S.
The U.S. Food and Drug Administration (FDA) has issued its approval for Breyanzi (lisocabtagene maraleucel) as the first-ever Chimeric Antigen…
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FDA Grants Approval for Avance Nerve Scaffold to Treat Sensory Nerve Damage
The U.S. Food and Drug Administration (FDA) has approved Avance (acellular nerve allograft-arwx), marking a significant advancement in the treatment…
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FDA Appoints Acting Director for Center for Drug Evaluation and Research
The U.S. Food and Drug Administration (FDA) announced the appointment of Tracy Beth Høeg, M.D., Ph.D., as the acting director…
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FDA Issues Early Alert on Glucose Monitor Sensor Risks from Abbott Diabetes Care
The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor sensors manufactured by Abbott…
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Critical Update: Olympus Modifies Use Instructions for Single Use Ligating Device PolyLoop
On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating Device PolyLoop. This update…
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FDA Proposes New Measures to Minimize Non-Human Primate Testing for Monoclonal Antibody Development
The U.S. Food and Drug Administration (FDA) has released proposed guidance aimed at reducing or eliminating the use of six-month…
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FDA’s Coordinated Crackdown: $1 Million Worth of 7-OH Opioids Seized in Missouri
The U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Justice (DOJ), took decisive action on…
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FDA Rolls Out Advanced AI Tools for Enhanced Regulatory Operations
The U.S. Food and Drug Administration (FDA) has announced a significant milestone: the organization is deploying agentic artificial intelligence (AI)…
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FDA Issues Urgent Recall for SJM Pericardial Patch Due to Quality Control Issue
An urgent recall has been announced for a specific lot of SJM Pericardial Patch devices distributed by Glycar SA. Health…
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FDA Issues Serious Correction Notification for BD Alaris Pump Modules Due to Safety Risks
The United States Food and Drug Administration (FDA) has released an updated correction notification for BD Alaris pump modules. These…
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Critical Recall Alert: Baxter Removes Life2000 Ventilator System Over Cybersecurity Risks
The FDA has announced a Class I recall for Baxter’s Life2000 Ventilation System, citing serious potential risks tied to cybersecurity…
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