FDA’s Real-Time Adverse Event Reporting Dashboard for Cosmetics: A New Era of Transparency
Published: September 2025 Imagine you bought a new shampoo, hair dye, or moisturizer. A few days later, you notice a rash, excessive itching, or even worse. What would you do? Report it—but often, you might wonder whether your report ever makes a difference. With the FDA’s launch of its new dashboard for real-time adverse event […]
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
Understanding the Guidance: What, Why, How In September 2025, the U.S. Food and Drug Administration (FDA) issued a nonbinding guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” U.S. Food and Drug Administration This document gives detailed recommendations for sponsors developing therapeutic protein biosimilars, especially how to design […]
FDA’s Guidance on Alternative Tools for Assessing Drug Manufacturing Facilities: What It Means for Pharma
In September 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance document titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.” This guidance redefines how regulators and industry navigate facility assessments for pending drug applications—including NDAs, ANDAs, and BLAs. The new framework signals FDA’s intent to use more flexible, risk-based […]
FDA’s New RDEP Framework: A Regulatory Deep Dive
On September 3, 2025, the FDA formally launched the Rare Disease Evidence Principles (RDEP) program, aimed at creating a clearer, faster pathway for therapies targeting ultra-rare, genetically driven diseases affecting fewer than 1,000 people in the U.S. U.S. Food and Drug AdministrationReuterswww.hoganlovells.com. What the RDEP Is — and Isn’t RDEP does not change the statutory […]
EPYSQLI® (Eculizumab-aagh) — A Landmark Biosimilar in Rare Disease Treatment
Introduction Samsung Bioepis’ EPYSQLI® (eculizumab-aagh) has earned FDA approval as a biosimilar to Soliris® (eculizumab). Approved on July 19, 2024, EPYSQLI offers a more affordable alternative for treating debilitating rare diseases.FDA Access DataSamsung BioepisU.S. Pharmacist Indications EPYSQLI is indicated for: Efficacy & Clinical Performance EPYSQLI matches the reference biologic in both efficacy and safety: Cost […]
Byetta (Exenatide): A Leap Forward in Type 2 Diabetes Management
Key Details from the FDA Record (NDA 021773) Indication & Efficacy Mechanism of Action Byetta is a GLP-1 receptor agonist. It: Patent & Exclusivity Insights
FDA Accepts VCTE Liver Stiffness as a “Reasonably Likely” Surrogate Endpoint in MASH: What Changed, Why It Matters, and What Happens Next
Date of FDA statement: August 27–28, 2025Scope: Adults with non-cirrhotic MASH and moderate-to-advanced fibrosis (trial context) TL;DR The FDA’s Office of New Drugs accepted a Letter of Intent (LOI) to qualify Liver Stiffness Measurement (LSM) by vibration-controlled transient elastography (VCTE)—e.g., FibroScan—as a reasonably likely surrogate endpoint (RLSE) for MASH trials. The proposed endpoint aims to […]
FDA Removes REMS Program for Clozapine: Insight, Rationale & Implications
1. What’s New? Effective June 13, 2025, the FDA officially eliminated the Clozapine REMS (Risk Evaluation and Mitigation Strategy) program for clozapine (e.g. Clozaril, Versacloz, generics) GovDeliverynewclozapinerems.com.In practice, as of February 24, 2025, the FDA no longer expects prescribers, pharmacies, or patients to enroll in REMS or report ANC results before dispensing clozapine U.S. Food […]
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 […]