What FDA's Peptide Decision Means for the Industry

Bristol Myers Squibb discloses results from it's Phase I Breakfree-2 trial of CAR-T therapy zola-cel for multiple sclerosis.

FDA has granted accelerated approval to Ultomiris based on Phase III data showing a 43.4% placebo-adjusted reduction at 34 weeks.

European regulators are increasing pressure on clinical trial sponsors to report study results on time, rolling out new monitoring, reminders and guidance as patient advocates welcome the progress but question whether stronger oversight and enforcement will follow.

Bristol Myers Squibb discloses a patient death in its Phase I CAR-T multiple sclerosis trial, Pathos AI launches multi-year collaborations with Bristol Myers Squibb and Tempus AI to advance Alzheimer’s drug development, and health economist Dr. Nadine Zawadzki speaks with The Ron Lanton Report on how value is defined across healthcare.

Pfizer’s talazoparib-enzalutamide combination moves to earlier line in prostate cancer, with eligibility tied to genetic testing and immature survival data.

Shionogi’s Dr. Draica on why COVID-19 still matters — and why the window between exposure and symptoms is where XOCOVA can intervene.

FDA approved an at-home induction option for risankizumab-rzaa in adults with moderate-to-severe Crohn's disease, based on the phase 3 AFFIRM trial.

The Treasury Department is proposing rules to add biotechnology to its Outbound Investment Security Program under the COINS Act.