Cover storyContinued Process Verification In Pharma: What Literature Shows
CPV theory is well understood, but literature shows execution is uneven, here's what real-world data reveals about running Stage 3 well.
Cover storyCPV theory is well understood, but literature shows execution is uneven, here's what real-world data reveals about running Stage 3 well.

Maharashtra FDA cancels Cipla Pune unit's drug sale licences over Reactin Plus labelling, recall, and storage failures.

FDA approves Stelara for paediatric UC in patients aged 2+, using an adult-data extrapolation plus paediatric PK pathway that sets a precedent for biologic sponsors.

FDA approves Takeda's Mimrylo (rusfertide), the first hepcidin mimetic for polycythemia vera, following priority review and Phase 3 VERIFY trial data.

FDA and ISoP's November 2023 workshop advances model-informed dosage optimization as a core regulatory expectation for oncology development.
Latest edition

Sep 28
Feb 03From native content to event partnerships, we help brands earn the attention of a hard-to-reach, senior audience — without breaking the reading experience.
See partnership options →Explore expert-led guides crafted for pharma professionals. Log in to download and stay ahead.








Join thousands of pharma professionals getting our sharpest reporting, briefings and guides — free.
