The first smallpox treatment, being developed for the United States government in the case of a bioterrorism attack, could be available as early as August.
A combination cancer treatment has been expanded to include treating both melanoma and anaplastic thyroid cancer (ATC).
FDA approved a new treatment for non-small cell lung cancer, as well as drugs to treat chronic immune thrombocytopenia and a rare form of childhood rickets.
FDA is permitting marketing of the first medical device that uses artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy.
FDA approved a new indication for Exparel Bupivacaine Liposome injectable suspension (Exparel, Pacira) for use as a nerve block to produce post-surgical regional analgesia following shoulder surgery in adults.
After US Surgeon General Jerome M. Adams, MD, MPH, urged more Americans to carry naloxone to reverse opioid overdoses, organizations and medical experts praised the decision.
A new deal between pharma giants AbbVie and Samsung Bioepis is designed to postpone competition against a biosimilar to Humira until 2023.
FDA okayed the marketing of a new continuous glucose monitoring system for diabetics—the first to be used as part of an integrated system with other compatible medical devices and electronic interfaces.
FDA’s approval of a new combination treatment for patients with classical Hodgkin lymphoma (cHL) is the first new advanced treatment for the disease in 40 years
Due to problems with compounded medications— including the 2012 fungal meningitis outbreak that led to 64 deaths—FDA is releasing a draft guidance that will determine which bulk drug substances outsourcing facilities can use to compound drugs.