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LEQEMBI IQLIK Subcutaneous Dose Gets US FDA Priority Review for Early Alzheimer's Disease
LEQEMBI IQLIK subcutaneous dose review by US Food and Drug Administration (FDA) extended after major sBLA amendment for early Alzheimer’s disease, with no approvability concerns raised.
PDUFA | 11/05/2026 | By News Bureau | 113
FDA Publishes Guidance on Modern Statistical Methods for Clinical Research
The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.
PDUFA | 14/01/2026 | By News Bureau | 114
Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis
PDUFA | 08/08/2023 | By Sudeep Soparkar | 746
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