Review Pathways
Payroll costs in the prescription drug user fee program increased in fiscal year 2025 despite the reduction-in-force and voluntary departures, which could impact industry efforts to reduce the annual charges.
The US FDA will seek industry feedback on the Commissioner’s National Priority Voucher pilot during a June public meeting as the ultra-fast drug review program marks its first year amid growing scrutiny of its scope, timelines, and sponsor obligations.
In a signal that prescription drug and generic drug user fee talks are nearing completion, the FDA and industry are preparing to start biosimilar user fee reauthorization talks with America First and other issues potentially looming.
The agency is conducting further investigation of reports of altered skin sensation that occurred more frequently with the 7.2 mg semaglutide dose than with lower doses of the GLP-1 inhibitor.
A regulatory roadmap and product development tracker, expedited scientific advice, and submission readiness meetings are being integrated into the European Medicines Agency’s decade-old priority medicines scheme.
Asieris Pharmaceuticals' hexaminolevulinate, for treating high-grade squamous intraepithelial lesions, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Now that CBER Director Vinay Prasad is leaving the FDA, Regenxbio's CEO is unsure a fast track pathway agreement will remain in place for its Duchenne muscular dystrophy gene therapy, RGX-202.
Pink Sheet editors discuss the direction of the FDA and CBER after Vinay Prasad’s exit, CBER’s similarities to the Harry Potter saga, as well as the Real-Time Oncology Review pilot’s contributions to Commissioner’s National Priority Voucher approval times.
Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.
So far this year, four drug candidates have secured a place on the European Medicines Agency’s priority medicines scheme for promising treatments for unmet medical needs.
Clinigen's CEO and senior executives outline how the services company navigated Japan’s rigorous regulatory framework to secure approval for Prolacta’s human milk–based fortifier as a prescription biological product.
The US FDA Commissioner's National Priority Voucher program is speeding clearance of products advancing agency priorities, but are recent quick approvals more attributable to the Real-Time Oncology Review (RTOR) program?
US FDA’s vaccine advisors will meet in March to make flu strain selection recommendations, but the context for the meeting makes a “routine” event feel extraordinary.
Vinay Prasad will leave the FDA less than a year after his initial arrival, having served two tenures as head of the biologics center.
Two recent CNPV approvals point to a practical submission-to-approval cadence of roughly three months, while the FDA’s filing‑to‑decision clock signals an even shorter timeframe.
Japan's regulatory authorities are implementing a number of updates and revisions to the national drug law in measures designed to address shortages of high-demand products and clarify guidance in areas including conditional approvals.
The agency offered to commission a third-party study of efficiency, workload and other factors to determine whether the base PDUFA revenue should be lowered mid-program cycle.
Neonatal drug development struggles with the lack of a standard of care and pervasive off‑label use, but the FDA’s growing preparedness for AI and real‑world evidence approaches offers an opening to harness NICU data to accelerate neonatal‑focused therapies.
Pink Sheet editors discuss the generic and biosimilars industries’ 2026 priorities as well as FDA Commissioner Martin Makary’s interesting take on the compassionate use program.
The FDA granted accelerated approval of zongertinib, a targeted non-small cell lung cancer treatment, in a first-line setting 44 days after the supplemental application was filed.