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Adverse Events

Device Malfunction Monitoring Hematologic Toxicity Device Malfunctions Injury Reporting Self-Administration Risks Major Bleeding Clinical Investigations Medication Complications Medical Interventions

Roche Starts Placebo-Controlled Phase 3 Trial of Elevidys to Pursue EU Approval

The study answers an EMA call for stronger, placebo-controlled evidence after a negative review.

Structure’s Oral Obesity Pill Delivers 16.3% Placebo-Adjusted Weight Loss in Phase 2

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

Roche’s CT-388 Shows Up to 22.5% Placebo-Adjusted Weight Loss in Phase 2 as Phase 3 Nears

Recalls Expand for Abbott FreeStyle Libre 3 Sensors Over False Low Readings

FDA Issues Early Alert on Certain FreeStyle Libre 3 Sensors After False Low Readings Linked to Harm

Protara Reports Strong Interim Phase 2 Results for TARA-002 in Pediatric Lymphatic Malformations

FDA Issues Safety Alert on RF Microneedling Injuries

Low-Dose Transplant Drug Preserves Beta Cells in Young People With Type 1 Diabetes, Phase 2 Trial Finds

World Patient Safety Day 2025 Centers on Safer Care for Newborns and Children

Capsida Halts STXBP1 Gene Therapy Trial After First Pediatric Participant Dies

Iza-Bren Plus Osimertinib Delivers 100% Response in Small First-Line EGFR-Mutant NSCLC Cohort

ESC Trials Recast Antiplatelet Strategies After PCI and CABG

Tandem Diabetes Announces Urgent Medical Device Correction for t:slim X2 Pumps

Safety and Cost Concerns Fuel Push to Restrict Spinal Cord Stimulators in Australia

Amgen Advances Monthly Obesity Drug to Phase 3 After 20% Weight Loss in Mid-Stage Trial

Sarepta Halts Elevidys Shipments for Non-Ambulatory Patients After Second Fatal Liver Failure

FDA Halts Rocket’s RP-A501 Gene Therapy for Danon Disease After Patient’s Death

Abortion Pill Study Fuels Debate Over Safety and Access

French Authorities Exclude Seniors from Chikungunya Vaccination After Serious Adverse Events