Regulatory Updates

FDA Approves Orally Disintegrating Nilotinib (Cavhanza) for Chronic Myeloid Leukemia

FDA · leukemia · 6 min

Ten-Year-Old Cambridge Biotech Seeks Merger or Acquisition Amidst Market Pressures

FDA · sickle cell · 6 min

Outlook Therapeutics Resubmits LYTENAVA BLA to FDA, Initiating 60-Day Review

FDA · 5 min

Hanmi Signs Licensing Deal with Eli Lilly for Sonefpeglutide, Bolstering GLP-2 Pipeline

FDA · 4 min

FDA Issues Final Guidance for Pulmonary Tuberculosis Drug Development

FDA · pulmonary tuberculosis · 5 min

Biosimilars Drive Significant Reductions in Specialty Drug Spending

9 min

ALX Oncology to Present at 2026 Jefferies Global Healthcare Conference, Highlighting Oncology Pipeline

oncology · 6 min

Legend Biotech's In Vivo CAR-T Data Sparks Stock Surge: A Catalyst Tracking Analysis

8 min

Advancing Bladder Cancer Care Through Education and Awareness

FDA · bladder cancer · 6 min

Fulcrum Explores Sale Amid FDA Setback for Sickle Cell Drug

FDA · sickle cell disease · 6 min

ASCO ‘26: Bispecifics, ADCs, and the RAS Revolution Reshape Oncology

prostate cancer · 7 min

This Week’s Biopharma News: New Approvals, Appeals, and AI

FDA · 10 min