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FDA clarifies cell and gene therapy potency standards
Final guidance explains how manufacturers can build potency checks into development, production,…
FDA Approves Voceryq for RRP Under Accelerated Pathway
The approval introduces an immune-based treatment option for adults whose airway growths…
FDA Grants Accelerated Rybrevant Faspro Approval for Head and Neck Cancer
The decision adds an option after prior treatments, while confirmatory studies must…
FDA Issues Final Guidance on prescription drug apps and Software
The framework explains how drug companies should handle companion software, prescribing information,…
FDA approves new chronic hepatitis B treatment, Hibsago
The injectable medicine offers certain adults another approach, but eligibility requirements and…
FDA approves once-weekly generic hormone therapy patch
The first generic of Climara Pro combines two hormones and is approved…
FDA Launches Rare Disease Framework Initiative
The initiative seeks a more predictable development process that accounts for small…
FDA approves rectal cancer immunotherapy for select adults
The accelerated approval applies to a small, biomarker-defined group, with longer follow-up…
WTC Health Program: Lessons 25 Years After 9/11
A CDC summary examines long-term health outcomes and the role of connected…
FDA Expands Approval of Anktiva for Bladder Cancer That Has Not Responded to BCG
The expanded indication covers a specific tumor type and draws on evidence…
CDC launches new overdose prevention data channel
The centralized resource pairs national and state overdose trends with prevention strategies…
FDA Reports Charges in Alleged Counterfeit Ozempic Scheme
The federal announcement describes alleged distribution to US sellers and explains how…
FDA seeks public input on ibogaine research
The agency is gathering evidence on early clinical trial design, with patient…
CDC releases kindergarten vaccination data for 2025-2026
The agency’s brief statement reports a small coverage decline and encourages parents…
US cancer death rates fall as lung cancer progress continues
The annual report tracks national trends while highlighting tobacco reduction and access…
