Does being an orphan speed up FDA approval?

Sun Pharma's IL-23 inhibitor tildrakizumab gains a psoriatic arthritis indication; the announcement cited no phase 3 efficacy figures.

Brox.AI's co-founder and CEO on why telling an AI to pretend to be a doctor isn’t the same as cloning one — and why that distinction matters for pharma.

Shionogi’s Dr. Draica on why mild COVID-19 still matters, how XOCOVA blocks replication before symptoms, and why prevention beats treatment.

Earlier pediatric planning, innovative trial design, and closer collaboration among regulators, industry, and families are needed to close the persistent gap between the evidence available for adult and pediatric treatments.

BioMarin licenses long-acting Fabry enzyme replacement therapy HM15421/GC1134A, while Ferring agrees to acquire fertility biotech Gameto.

As AI accelerates drug discovery, the industry’s next challenge is building a connected, standards-based data infrastructure capable of supporting it through clinical development.

Shionogi’s Dr. Draica on why mild COVID-19 can worsen chronic conditions for up to a year — and why prevention matters more than hospitalization data suggests.

Brock.AI’s Hamish Brocklebank on recruiting 8% of all US pancreatic cancer prescribers — paying $2,000 an hour, offering equity, and triple opt-in consent.