Blog: FDA Urges Strict Adherence to Safe Use of Hyperbaric Oxygen Therapy Devices
1. Context & Safety Warning On August 25, 2025, the FDA issued a Letter to Health Care Providers, reminding clinicians and facilities of the…
Read more →FDA Suspends Biologics License for Ixchiq: A Safety-Driven Pivot
What Happened? On August 22, 2025, the FDA’s Center for Biologics Evaluation and Research (CBER) suspended the biologics license for Ixchiq® (VLA1553)—Valneva’s live-attenuated chikungunya…
Read more →FDA Launches Real-Time Reporting of Adverse Event Data
A Leap Toward Transparency & Speed On August 22, 2025, the U.S. Food and Drug Administration (FDA) initiated daily publication of adverse event data…
Read more →Qfitlia (fitusiran): a practical, evidence-based look at the newly approved hemophilia prophylaxis
Summary: On March 28, 2025 the U.S. FDA approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce bleeding in people 12 years and…
Read more →Article: FDA Issues New Guidance on Animal Studies for Dental Bone Grafting Materials
Background & Purpose On August 22, 2025, the FDA released its latest guidance titled “Animal Studies for Dental Bone Grafting Material Devices – Premarket…
Read more →FDA Safety Labeling Change: CORTISPORIN® Ointment — What Changed, What to Update, and How Shudarsana Can Help
What changed (SrLC highlight) On Aug 8, 2025 (SUPPL-86) the FDA approved an update to Adverse Reactions adding the statement: “Skin hyperpigmentation has been…
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