FDA Recommends Earlier MRI Monitoring for Leqembi (lecanemab): What Changed, Why It Matters, and the Real-World Impact
Date of FDA communication: August 28, 2025 Summary (TL;DR) The FDA now recommends an additional, earlier brain MRI before the 3rd Leqembi infusion (previously before the 5th, 7th, and 14th). The shift follows an analysis of serious ARIA-E cases and six early-treatment fatalities, suggesting earlier imaging may detect brain swelling sooner and help clinicians pause […]
FDA Presses Nicotine Pouch Makers to Adopt Child-Resistant Packaging
Background & Key Findings On September 2, 2025, the U.S. Food and Drug Administration (FDA) issued a formal call urging manufacturers of nicotine pouches to implement child-resistant packaging, responding to a dramatic rise in accidental exposures — particularly among very young children U.S. Food and Drug Administration+1. From April 1, 2022 through March 31, 2025, […]
EMA backs first low-carbon propellant for a licensed inhaler: what’s changing with Trixeo/Riltrava Aerosphere, and why it matters
The headline On July 25, 2025, the European Medicines Agency (EMA) announced that it recommended a change in the propellant for two pressurised metered-dose inhalers (pMDIs) used in COPD—Trixeo Aerosphere and its duplicate product Riltrava Aerosphere. The current hydrofluorocarbon (HFC) propellant HFA-134a will be replaced with HFO-1234ze(E), a low-global-warming-potential (GWP) alternative. EMA highlights that this […]
EMA CHMP Spotlight: July 21–24, 2025 Meeting Highlights
1. New Medicines Recommended for Approval The EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed promising therapies and issued positive opinions for 13 new medicines, including treatments targeting rare, life-threatening, or underserved conditions.European Medicines Agency (EMA) Notable approvals: 2. Biosimilars & Generics: Expanding Access The CHMP also issued positive opinions for four biosimilars […]
B. Braun Voluntary Nationwide Recall: What You Need to Know
Recall Overview Clinical Background & Trial Context While the recall centers on manufacturing quality, here’s what clinical data tells us about these fluids: Overview of Clinical Efficacy & Safety Comparative Studies Label-Referenced Safety Considerations Pharmacovigilance Impact Public Health & Real-World Considerations Summary Table Category Details Recall Details Two lots of 1000 mL LR and saline; […]
FDA Issues Class I Recall for Boston Scientific Carotid Stent
What Happened: Scope & Rationale On August 22, 2025, the FDA classified as Class I the recall of Boston Scientific’s Carotid WALLSTENT Monorail Endoprosthesis, a self-expanding stent used to treat carotid artery narrowing U.S. Food and Drug AdministrationCardiovascular Business. Affected models (over 26,000 globally, including 1,333 in the U.S.) were found to have a manufacturing […]
FDA Issues Import Alerts on Olympus Medical Devices Made in Japan
Background & Regulatory Action On June 24, 2025, the U.S. Food and Drug Administration (FDA) issued Import Alert 89-04, targeting certain Olympus medical devices manufactured at its Aizu facility in Fukushima, Japan. These include: The alert effectively blocks 58 specific models from entering the U.S., citing ongoing violations of Quality System regulations (QSR) despite Olympus’ […]
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 critical importance of following manufacturer instructions when using hyperbaric oxygen therapy (HBOT) devices—given rising reports of serious injuries and fatalities U.S. Food and Drug Administration. Key recommendations include: The FDA emphasized […]
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 vaccine—citing serious safety concerns. The decision is grounded in evidence that the vaccine may be causing chikungunya-like illness, including encephalitis, hospitalizations, and fatalities.citeturn0search0turn0search1 This move follows a prior May 9, 2025 […]