safety review – Talk Bio

CDC highlights strong effectiveness of 2024–2025 COVID-19 shots in kids while FDA reviews reports of alleged post-vaccination deaths

3 days ago talkbio0Tagged alleged deaths, Centers for Disease Control and Prevention (U.S.), Child, COVID19 (disease), Effectiveness, Emergency department patient visit, Pediatrics, safety review, United States Food and Drug Administration, urgent care visits, Vaccines, VAERS

CDC; FDA; COVID-19 vaccine; children; pediatrics; vaccine effectiveness; emergency department visits; urgent care visits; safety review; alleged deaths; VAERS

FDA reviews safety of approved RSV antibodies for infants

5 days ago talkbio0Tagged AstraZeneca, Beyfortus, Infant, Merck, nirsevimab, palivizumab, Respiratory syncytial virus, RSV antibodies, safety review, sanofi, United States Food and Drug Administration

FDA; RSV; nirsevimab; Beyfortus; palivizumab; RSV antibodies; infant safety review; Sanofi; AstraZeneca; Merck; respiratory syncytial virus

FDA Broadens COVID-19 Vaccine Safety Probe to Adults Under New Health Leadership

5 days ago talkbio0Tagged Adult, COVID19 (disease), Moderna, Myocarditis, Pfizer, public trust, safety review, United States Food and Drug Administration, vaccine deaths, Vaccines

FDA; COVID-19 vaccines; safety review; adults; Robert F. Kennedy Jr.; vaccine deaths; public trust; Pfizer; Moderna; myocarditis

Diamyd Medical’s Pivotal Phase 3 Type 1 Diabetes Trial Clears Final Safety Review Ahead of Early Readout in March 2026

1 month ago talkbio0Tagged Accelerated, approval pathway, Data Safety, Diabetes Mellitus, Insulin-Dependent, DIAGNODE-3, Diamyd Medical, DSMB, fast-track designation, Genotype, HLA DR3-DQ2, interim readout, Monitoring Board, orphan drug designation, Phase 3 trial, precision therapy, safety review

Diamyd Medical; Type 1 Diabetes; Phase 3 trial; DIAGNODE-3; safety review; Data Safety Monitoring Board (DSMB); interim readout; March 2026; HLA DR3-DQ2 genotype; Orphan Drug Designation; Fast Track Designation; accelerated approval pathway; precision therapy

Protect Your Trial Data: Endpoint, Imaging, and Safety Review

7 months ago talkbio0Tagged Biomechanical compliance, Clinical Trials, CTMS, Diagnostic Imaging, Encryption, End Point, General Data Protection Regulation, safety review, Security - service

Clinical Trials, Diagnostic Imaging, Security – service, End Point, safety review, General Data Protection Regulation, Biomechanical compliance, CTMS, Encryption

MacroGenics Reviews Safety Protocols Following Three Patient Deaths in Prostate Cancer Drug Trial

2 years ago talkbio0Tagged Antibodies, Bispecific, Cessation of life, MacroGenics, Malignant neoplasm of prostate, margetuximab, Phase 2 trial, safety review

MacroGenics, Phase 2 trial, prostate cancer, patient deaths, safety review, margetuximab, bispecific antibody