June 20, 2025
FDA’s Top Cell and Gene Therapy Leaders Exit Amid CBER Upheaval
FDA; cell therapy; gene therapy; CBER; Nicole Verdun; Rachael Anatol; Peter Marks; leadership changes; biopharma regulation
CHMP Recommends Five New Drugs and Reviews Eli Lilly’s Kisunla
CHMP; EMA; new drug approvals; Eli Lilly; Kisunla; biosimilars; hyperphosphatemia; myopia; March 2025; regulatory review
Inside the FDA’s Listening Tour: Officials Agree US Lags Behind China on Drug Development
FDA; China; drug development; biotechnology; regulation; clinical trials; pharmaceutical industry; biotech innovation
Gilead Wins Groundbreaking FDA Approval for Twice-Yearly HIV Prevention Shot
Gilead; FDA approval; lenacapavir; Yeztugo; HIV prevention; twice-yearly injection; PrEP; long-acting injectable; WHO guidelines
Zealand Pharma’s Dual GLP-1/GLP-2 Agonist Dapiglutide Shows Promising 11.6% Weight Loss at 28 Weeks
Zealand Pharma; dapiglutide; GLP-1; GLP-2; weight loss; obesity; phase 1b trial; clinical trial; dual agonist; safety
Recent Developments in Immune Profiling for Early Immuno-Oncology Trials
immune profiling; immuno-oncology; clinical trials; AI in immunotherapy; multi-omic strategies; tumor microenvironment; spatial proteomics; biomarker discovery; personalized medicine
FDA Grants Dupixent (Dupilumab) Eighth Approval: Now Cleared for Bullous Pemphigoid
Dupixent; Dupilumab; Sanofi; Regeneron; bullous pemphigoid; FDA approval; type 2 inflammation; autoimmune disease; priority review; orphan drug