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…
Read more →FDA Safety Labeling Update — BRIVIACT (brivaracetam)
Source: FDA Drug Safety-related Labeling Changes database (BRIVIACT entry). FDA Access Data Last update What changed (high-level) The August 28, 2025 supplement adds a…
Read more →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…
Read more →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,…
Read more →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…
Read more →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…
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