Postmarket Safety Actions for Novel Oncology Drugs Granted FDA's Accelerated Approval.
Mooghali M +4 more
europepmc +1 more source
Postmarketing safety of bimekizumab for hidradenitis suppurativa: An early pharmacovigilance analysis using the United States Food and Drug Administration Adverse Event Reporting System. [PDF]
Alomary SA +3 more
europepmc +1 more source
GLP-1 receptor agonists and functional gastrointestinal obstruction: mechanistic rationale, emerging evidence, and clinical implications. [PDF]
Riaz L +4 more
europepmc +1 more source
Mid- to Long-term Outcomes Following Primary Augmentation With B-Lite Lightweight Breast Implants: A Prospective Multicenter Postmarketing Clinical Follow-up Study. [PDF]
Reichenberger M, Hedén P, Germann G.
europepmc +1 more source
Expedited research and approval of medicines for drug-resistant bacterial infections in children. [PDF]
Williams PC +7 more
europepmc +1 more source
Adverse events associated with use of immunoglobulin in pediatric patients reported to the US Food and Drug Administration Adverse Event Reporting System, 2001-2023. [PDF]
Wei S +4 more
europepmc +1 more source
Policy Without Penalty: A Review of Pediatric Research Equity Act Noncompliance Letters. [PDF]
Green DJ +3 more
europepmc +1 more source
Navigating hepatotoxicity of antibody-drug conjugates: from mechanistic insights to clinical and postmarketing evidence. [PDF]
Dong Y +9 more
europepmc +1 more source
Japanese evidence on Janus kinase inhibitors for rheumatoid arthritis: a narrative review of risk-optimized use. [PDF]
Matsumoto H +12 more
europepmc +1 more source

