Compounded Medicines: FDA Safety Risks Doctors and Patients Should Understand
What FDA guidance says about compounded medicines, quality risks, approved alternatives and the limits of overseas regulatory information.
Drugs
Regulatory approvals, medicine status, safety communications and evidence-based drug updates.
FDA Accelerated Approval of Sevabertinib: What Is Known and What Remains Uncertain
An evidence-focused explainer of the FDA accelerated approval of sevabertinib, including limitations and India regulatory status.
FDA Approves First Treatment for Alexander Disease: What the Evidence Shows
FDA has approved zilganersen as the first treatment for Alexander disease. Review the mechanism, trial evidence, safety signals and important limitations.