FDA Grants Approval to Avance Nerve Scaffold for Treating Sensory Nerve Discontinuity
The U.S. Food and Drug Administration (FDA) has approved Avance (acellular nerve allograft-arwx), a novel nerve scaffold, for surgical implantation…
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FDA Grants Regulatory Approval for Cellular Therapy to Address Severe Aplastic Anemia
The U.S. Food and Drug Administration (FDA) has taken a landmark step by granting approval for Omisirge (omidubicel-onlv), a hematopoietic…
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FDA Approves Augmentin XR under New Voucher Program to Boost Antibiotic Production
The U.S. Food and Drug Administration (FDA) has announced the first approval under the Commissioner’s National Priority Voucher (CNPV) pilot…
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FDA Grants Historic Approval to Gene Therapy for Wiskott-Aldrich Syndrome
The U.S. Food and Drug Administration (FDA) has approved Waskyra (etuvetidigene autotemcel), marking a significant milestone as the first cell-based…
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FDA Moves to Include Bemotrizinol in Sunscreen Formulations: A Regulatory Update
The U.S. Food and Drug Administration (FDA) announced a major step forward in sunscreen product development on December 13, 2025.…
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FDA Authorizes Two New Oral Treatments for Gonorrhea, Marking a Regulatory Milestone
The U.S. Food and Drug Administration (FDA) has approved two novel oral therapies for gonorrhea, a significant milestone in addressing…
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FDA Highlights Nationwide Recall of ReBoost Nasal Spray Over Microbial Risks
MediNatura New Mexico, Inc. has issued a voluntary recall of one lot of ReBoost Nasal Spray across the United States…
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Cargill Issues Voluntary Recall of Nutrena® Country Feeds® Cracked Corn Due to Elevated Aflatoxin Levels
On December 9, 2025, Cargill Animal Nutrition & Health announced a voluntary recall of one specific lot of Nutrena® Country…
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FDA Alerts: ReBoost Nasal Spray Recalled Nationwide Due to Microbial Contamination
MediNatura New Mexico, Inc. has announced a voluntary nationwide recall of one lot of its ReBoost Nasal Spray as of…
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Critical FDA Alert: Power Management Issues in GE HealthCare Anesthesia Systems
The U.S. Food and Drug Administration (FDA) has issued an early alert regarding a potentially high-risk issue in certain anesthesia…
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FDA Unveils TEMPO Pilot Program to Boost Safe Access to Digital Health Tools for Chronic Diseases
The U.S. Food and Drug Administration (FDA) has announced a groundbreaking initiative aimed at improving access to digital health technologies.…
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FDA Introduces TEMPO Digital Health Pilot to Improve Chronic Disease Care Access
The U.S. Food and Drug Administration (FDA) unveiled the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot on…
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