Regulatory Updates

Monopar Starts Rolling NDA for ALXN1840 Wilson

FDA · Rare Diseases · 3 min

FDA Accepts Daraxonrasib NDA for Pancreatic Cancer

FDA · Oncology · 3 min

Commissioner National Priority Voucher CNPV Pilot

FDA · Regulatory Policy · 3 min

FDA Finalizes Guidance on Clinical Trial Design

FDA · Psychiatry · 3 min

FDA Activity Round Up July 2026

FDA · 3 min

Drug Repurposing Stakeholders Say FDA Should Act

FDA · 3 min

Compounded GLP-1s Why doctors worry and FDA acts

FDA · Metabolic Disorders · 3 min

FDA approves OTC Rextovy, broadening naloxone access for opioid overdose

FDA · opioid overdose · 6 min

Lilly buys 4E in non-opioid pain push: what investors should watch

FDA · moderate to severe acute pain · 6 min

Lilly’s early JAK data raises myelofibrosis competition question

FDA · myelofibrosis · 6 min

FDA authorizes emergency pet treatment for New World screwworm

FDA · New World screwworm · 4 min

FDA guidance on sharing potential NDA patent information: what changes now

FDA · 4 min