Inside PRAC (Sept 2025): What EMA’s Safety Experts Decided, and What That Means for You
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) met from 1-4 September 2025. Their role: monitor the safety of medicines in the EU, assess risk signals, recommend actions, and ensure the benefit/risk of drugs remains favorable. Here are the key takeaways from the meeting, plus deeper insight into why they matter. Key Decisions & […]
When Sleep Therapy Devices Go Wrong: Philips DreamStation Ventilator Recall Explained
Sleep apnea affects millions. For many, devices like CPAPs or BiPAPs are lifelines — nightly helpers that keep airways open, ensure proper oxygenation, and protect against serious health risks. So when devices meant to heal can potentially misbehave, it’s a serious matter. Recently, Philips Respironics initiated a recall for certain DreamStation Auto CPAP / Auto […]
When Your CGM Says “No Active Sensor” but Isn’t Warning You: Dexcom’s App Correction & Its Impact
Imagine relying on a continuous glucose monitor (CGM) app to track your blood sugar—only to have the sensor fail and the app quietly stop sending data. You see the “No active sensor” screen and assume everything is OK or that it’s just a small glitch. But it’s not. Because the app didn’t alert you to […]
Breaking News: FDA Expands IZERVAY™ Label for Long-Term Use in Geographic Atrophy Management
1. What’s New? The U.S. Food and Drug Administration has approved an expanded prescribing label for IZERVAY™, enabling unlimited duration dosing in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) Astellas Pharma US, Inc. | News Room. Previously, treatment duration was capped at 12 months. 2. Clinical Evidence Behind the Expansion This […]
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 […]
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 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 new safety subsection describing Serious Dermatologic Reactions (including Stevens–Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) and updates related adverse reaction and patient counseling sections to reflect these postmarketing reports. FDA […]
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 […]