FDA News

FDA Approves Oral Nilotinib Tablets for Ph+ CML: A New Era for Treatment

FDA · Ph+ CML · 6 min

FDA Approves Xocova: A Catalyst for Pharmaceutical M&A and Licensing

FDA · 8 min

Cencora-Kite Agreement: A New Era for CAR T-cell Therapy Commercialization

FDA · CAR T-cell therapies · 7 min

FDA Grants Priority Review to Giredestrant for ER+/HER2- Breast Cancer

FDA · breast cancer · 6 min

FDA's Shifting Tides: Navigating Clinical Trials Amidst Regulatory Uncertainty

FDA · 9 min

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

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