RYBREVANT (amivantamab-vmjw) 2025 Label: What Changed, Why It Matters, and How to Apply It in Practice
Bottom line: In early 2025 the RYBREVANT label tightened safety language (notably infusion-related reactions, anaphylaxis placement, and venous thromboembolism management with lazertinib) and clarified dosing/administration details. Later in 2025, FDA accepted a supplement to update overall survival results from MARIPOSA, which will flow into Clinical Studies once the updated PI posts. Together, these moves round […]
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 […]
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 […]
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 Notification (510(k)) Submissions,” building upon the original Dental Bone Grafting Guidance from 2005 U.S. Food and Drug Administration+1. The document offers nonbinding recommendations on conducting animal studies for dental bone grafting […]
FDA Safety Labeling Changes for ACTEMRA (tocilizumab): What Changed, PV & Regulatory Impact, and a Playbook for Shudarsana
What changed in the U.S. label Newest update (August 8, 2025): Recent prior update (September 2024): Practical takeaway: Two concurrent risk domains now shape operations—expanded pediatric COVID-19 use (dosing, handling, benefit–risk) and heightened vigilance for severe hypersensitivity/SCARs. FDA Access Data+1 What needs to change internally (manufacturer/MAH “to-do” list) Pharmacovigilance impact Signal detection & case processing […]
Ensuring Patient Safety: FDA’s Draft Guidance on Assessing Overall Survival in Oncology Clinical Trials — A Multi-Perspective Analysis
Article 1. Regulatory Perspective The FDA’s August 2025 draft guidance outlines recommendations for evaluating Overall Survival (OS) in randomized oncology trials, particularly when OS isn’t the primary endpoint U.S. Food and Drug Administration. 2. Pharmacovigilance Perspective OS serves not only as efficacy but a critically objective safety endpoint. 3. MAH (Marketing Authorization Holder) Perspective From […]